Category: Manufacturing

Exciting news has surfaced in the biotech industry as the FDA has accepted the resubmission of the Biologics License Application (BLA) for Linvoseltamab, a promising therapeutic agent. This milestone signifies a step closer towards bringing innovative treatment options to patients in need. However, behind this achievement lies a complex web of biotech manufacturing operations that […]

As I step into my role as the new leader of Severn Trent, I am continually inspired by the dedication and enthusiasm demonstrated by the employees, whom I fondly refer to as “Severn Trenters.” Their commitment to providing clean water and excellent service to customers is truly commendable. Each day, I witness firsthand the passion […]

In the realm of biotech manufacturing operations, the quest for enhanced precision and efficiency is a perpetual pursuit. A recent study has shed light on the transformative potential of radiomics-based models in accurately diagnosing Multiple Myeloma (MM) and bone metastases. This breakthrough not only signifies a significant advancement in medical diagnostics but also holds immense […]

Pharmaceutical Technology recently interviewed Lisa Crandall, MS, and Peter Angus, PhD, from Velesco Pharma, delving into the critical topic of determining drug stability in pharmaceutical development. The discussion shed light on various best practices and methodologies employed in stability testing to ensure the efficacy and safety of API and drug products. In the early stages […]

In the realm of topical drug manufacturing, the mastery of critical process parameters (CPPs) is paramount to ensure a seamless and efficient manufacturing process. From temperature control to mixing methods and flow rates, every detail plays a crucial role in the quality and consistency of topical formulations. Let’s delve into the intricacies of these CPPs […]

In the dynamic landscape of parenteral manufacturing, aseptic connectors have emerged as a crucial technology, enabling the possibility of production outside the confines of the cleanroom. These connectors play a pivotal role in enhancing manufacturing flexibility, reducing costs, and improving production economics, especially with the increasing adoption of single-use systems in the biopharmaceutical industry. The […]

In the realm of sterile cleanrooms, the shift from traditional settle plates to active air microbial monitoring is a topic of increasing relevance and interest among experts. This transition not only offers potential time and cost savings but also holds the promise of reducing the risk of product contamination. Let’s delve into the world of […]

In the intricate dance of biotech collaborations, Abzena, a Contract Development and Manufacturing Organization (CDMO), has taken center stage with a mesmerizing performance alongside the biotechnology firm Mabqi. This strategic partnership is not merely a duet but a harmonious ensemble, blending Mabqi’s mastery in antibody discovery with Abzena’s prowess in development and manufacturing services. Together, […]

ROSTI, a Swedish plastic injection moulding company and contract manufacturer, has recently made a significant stride in expanding its presence in Asia with the inauguration of a cutting-edge production facility in Chennai, India. This new facility, established on 5th November 2025 in the ESR Oragadam industrial Park, marks ROSTI’s third site in Asia, highlighting the […]

PSCI, a Delaware-based company, recently announced an expansion of its IT consulting and staffing services to cater to the rising demand for specialized technical talent across various industries. This move solidifies PSCI’s position as a leading provider of information technology staffing solutions for different types of clients. The company aims to align with the evolving […]

In the realm of cutting-edge biotechnology, cell and gene therapies (CGT) stand out as revolutionary treatments with the potential to cure previously incurable diseases. However, despite their immense promise, the high cost of manufacturing these therapies has presented a significant barrier to widespread adoption. The heart of this challenge lies in the complex and labor-intensive […]

Prefilled syringes have emerged as a groundbreaking innovation in the realm of parenteral packaging, transforming the landscape of drug delivery with their convenience, safety, and precision. These ready-to-use syringes come pre-filled with a specific dosage of medication, eliminating the need for manual filling by healthcare providers or patients. With the global pharmaceutical industry witnessing a […]

In the fast-paced world of biotech manufacturing, operational efficiency is the key to success. As a biotech manufacturing operations leader, you are constantly challenged to maximize plant capacity, mitigate batch failures, and ensure a robust supply chain. These aspects are critical for meeting the increasing demand for life-saving therapies and staying ahead in a competitive […]

In the fast-paced world of biotech manufacturing operations, efficiency and speed are paramount. Recently, the integration of artificial intelligence (AI) has been a game-changer, revolutionizing the way processes are streamlined and optimized. One of the most significant impacts of AI in this sector has been the slashing of clinical trial approval times by half, a […]

In the ever-evolving landscape of biotech manufacturing operations, Amgen is taking bold steps to enhance patient access to Evolocumab through a direct-to-patient program. This initiative comes at a crucial time as the United States grapples with significant drug pricing reforms that are reshaping the pharmaceutical industry. By bypassing traditional distribution channels, Amgen aims to streamline […]

Greetings fellow biotech manufacturing enthusiasts! Today, we delve into the fascinating realm of biotech manufacturing operations, where science, technology, and production intertwine to bring life-changing products to the world. As a biotech manufacturing operations leader, you are the orchestrator of this intricate dance, ensuring seamless processes, maximal plant capacity utilization, and optimal supply chain management […]

In the fast-paced world of biotech manufacturing, operational efficiency is a key determinant of success. Plant capacity, batch failures, and supply chain disruptions can make or break a company’s ability to deliver life-saving therapies to patients in need. As a biotech manufacturing operations leader, it is crucial to navigate these challenges with pragmatism and strategic […]

The biotech industry is a dynamic and ever-evolving landscape, where operational excellence is paramount for success. As a biotech manufacturing operations leader, you are constantly faced with challenges ranging from plant capacity constraints to supply chain disruptions. The recent modeling suggesting that America could be ‘flirting with recession’ if tech investment slows serves as a […]

In the realm of biotech manufacturing operations, capacity planning is a critical aspect that requires meticulous attention to detail and strategic foresight. Just as in the world of politics where endorsements can sway outcomes, decisions made in manufacturing can have far-reaching implications on efficiency, production timelines, and ultimately, the success of the business. When considering […]

In the realm of biotech manufacturing operations, ensuring efficiency and scalability is paramount to meet the demands of a dynamic market. From plant capacity to supply chain management, every aspect plays a crucial role in driving success and maintaining competitiveness. Let’s delve into the key factors impacting biotech manufacturing operations and explore strategies to optimize […]

In the realm of global energy dynamics, recent developments within the European Union have sparked fiery debates and raised concerns across the oil and gas industry. ExxonMobil’s CEO, Darren Woods, recently made waves with his scathing criticism of the EU’s proposed Corporate Sustainability Due Diligence Directive. This legislation, aimed at enforcing social responsibility and environmental […]

Eli Lilly, the renowned pharmaceutical company based in Indianapolis, has unveiled its ambitious plan to construct a cutting-edge manufacturing facility in Goochland County, Virginia, with a staggering investment of $5 billion. This state-of-the-art facility is poised to not only create significant employment opportunities but also revolutionize the landscape of biopharmaceutical manufacturing in the region. Amidst […]

GSK, a pharmaceutical giant based in London, has unveiled a monumental commitment of $30 billion to bolster research and development efforts, along with the entire pharmaceutical supply chain, in the United States over the next five years. This substantial investment encompasses advancements in biopharma manufacturing, clinical research, and the implementation of cutting-edge technologies like AI […]

The recent decision by the Federal Reserve to cut its benchmark interest rate by a quarter point has sparked discussions on the potential impacts it may have on various lending rates and the overall economy. With the Fed hinting at the possibility of two more cuts by the year’s end, the move has generated both […]

Machina Labs, a trailblazer in the realm of defense manufacturing, secures a prestigious contract from the US Air Force Research Laboratory (AFRL) to bolster its cutting-edge RoboCraftsman platform with advanced AI and machine learning capabilities. This strategic move is set to propel the Department of Defense (DoD) sustainment modernization efforts into a new era of […]

Pharma giant Eli Lilly’s recent announcement of a $5 billion investment in a new manufacturing facility at the Markel-owned West Creek site in Goochland County marks a significant milestone in the region’s economic development landscape. The unveiling of this massive project has sparked excitement and speculation about the potential implications for the area’s growth and […]

BWXT, a trusted partner in advancing the nation’s nuclear defense mission, has been awarded a monumental $1.5 billion contract by the National Nuclear Security Administration (NNSA). This contract aims to establish a crucial domestic uranium enrichment capability to meet defense requirements, solidifying BWXT’s pivotal role in supporting national security initiatives. The contract entails the construction […]

In a groundbreaking move, BWX Technologies (BWXT), a Lynchburg-based nuclear components manufacturer, has secured a monumental $1.5 billion contract from the National Nuclear Security Administration (NNSA). This contract aims to bolster the United States’ domestic uranium enrichment capability for defense purposes. The subsidiary of BWXT, named BWXT Enrichment Operations, will spearhead the design, construction, and […]

In the dynamic landscape of pharmaceuticals, where innovation and manufacturing go hand in hand, two major players are making waves with substantial investments in US facilities. Let’s dive into the exciting developments from GSK and Lilly as they gear up to bolster their presence in the American pharmaceutical market. GSK’s $30 Billion Commitment to US […]

In a captivating dialogue with Bo Zhang from Xiamen University, we delve into the groundbreaking realm of 3D-printed column technology, poised to redefine the landscape of chromatography manufacturing. This innovative approach not only challenges the conventional methods of slurry packing and casting but also heralds a new era of precision and scalability in chromatography. Zhang […]

In the realm of biotechnology, the utilization of lipid nanoparticles (LNPs) for RNA delivery has emerged as a pivotal strategy, with a surge in clinical applications ranging from vaccines to disease treatments. The advent of microfluidics has revolutionized the manufacturing of LNPs, offering scalability, reproducibility, and rapid preparation. This study delves into the essential operating […]

In a significant move that reverberates across the additive manufacturing (AM) landscape, Kanfit, a distinguished build-to-spec engineering and manufacturing company, has recently acquired NanoParticle Jetting (NPJ) solutions from XJet. This acquisition marks a pivotal moment for Kanfit as it embraces cutting-edge ceramic and metal AM technology, solidifying its foothold in the industry. Among the prized […]

California lawmakers recently passed a bill aiming to expand manufacturing decarbonization projects by making thermal energy storage and industrial heat pumps eligible for financial incentives within various state programs. The INDIGO program in California, established in 2022, provides incentives for industrial projects that benefit the electrical grid, reduce emissions, and enhance air quality. For instance, […]

Hey there, biopharma enthusiasts! Hold onto your lab coats because Eli Lilly is making waves with its latest announcement. Picture this: a cutting-edge manufacturing plant nestled in the heart of Goochland County, poised to employ a whopping 650 individuals once it hits full throttle. Now, that’s what I call a prescription for success! Breaking Down […]

Romania’s industrial sector has demonstrated signs of resilience and recovery, evidenced by a notable 4.0% year-on-year increase in output during the period of May to July. This positive momentum follows a steady upward trend in performance over the past year, with an annual growth rate of +2.9%. However, while recent data indicates improvement, there are […]

In the realm of pharmaceuticals, the interest in therapeutic oligonucleotides is burgeoning, prompting a crucial shift towards embracing sustainability within the oligonucleotide manufacturing landscape. The current practices in oligonucleotide production are laden with inefficiencies, utilizing copious amounts of hazardous reagents, solvents, and energy-intensive processes throughout synthesis, purification, and isolation stages. Recognizing this unsustainable trend, the […]

Engineering enthusiasts, behold! Eschbach has unleashed a game-changer in the realm of manufacturing with the introduction of their Shiftconnector plug-in for SAP Digital Manufacturing. This revolutionary software integration transcends traditional MES functions, empowering shop floor teams with advanced tools for seamless collaboration and communication. The Marriage of Machine Data and Human Interaction Picture this: SAP […]

The MedTech sector in India, as highlighted by JP Nadda, plays a crucial role in transforming healthcare through diagnostics, advanced devices, digital health, and AI-driven solutions. These innovations not only enhance accessibility and efficiency but also make healthcare more affordable for all citizens. With government support focusing on access, innovation, and infrastructure development, the sector […]

In the fast-paced world of food manufacturing, the skills gap is a real challenge for industry leaders. They are implementing innovative strategies to address this issue head-on and ensure they have the skilled workforce needed to succeed. Let’s explore some proven tactics being utilized by these forward-thinking companies. Regional Talent Ecosystems: Cultivating Collaboration Collaborating with […]

XPeng Inc. (NYSE:XPEV) has made waves in the electric vehicle (EV) industry by forging a strategic partnership with Magna International Inc. (NYSE:MGA) to produce two electric vehicle models in Europe. This collaboration marks a significant milestone for XPeng as it ventures into localized production at Magna’s facilities in Graz, Austria. The production is set to […]

Two of the foremost European solar trade associations, the European Solar Manufacturing Council (ESMC) and SolarPower Europe (SPE), have issued a resounding call to action directed at EU policymakers. The crux of their message revolves around the urgent necessity for increased support to bolster European solar manufacturing. Against the backdrop of a solar industry facing […]

Luminary Cloud Inc., a pioneering startup based in San Mateo, California, has recently secured a substantial $72 million in funding to propel its mission of integrating artificial intelligence into the realm of physical product design. This funding marks a significant milestone for the company, solidifying its position as a key player in the evolution of […]

In the realm of biopharmaceutical innovation, where precision and efficiency reign supreme, WuXi Biologics has emerged as a beacon of cutting-edge technology and unwavering commitment to excellence. The recent announcement of their intensified perfusion culture process platform, WuXiUP, achieving fully automated continuous drug substance (DS) production at pilot scale marks a monumental leap forward in […]

The landscape of cell therapies is rapidly evolving, propelled by the success of groundbreaking treatments like Novartis’ Kymriah for leukemia. However, the current manufacturing processes are struggling to keep up with the demand for consistent, high-quality therapies that are accessible globally. As someone deeply entrenched in the field of biologics and cell-based therapies, I have […]

In the dynamic landscape of biotech manufacturing, optimizing operations is paramount to ensure efficiency, scale, and success. As a seasoned biotech manufacturing operations leader, it is crucial to navigate the intricate web of challenges such as plant capacity limitations, batch failures, and supply chain disruptions to drive operational excellence. This article delves into the strategies […]

In a surprising turn of events, AstraZeneca has recently announced the suspension of its $270 million commitment to establish a new manufacturing facility in the UK. This decision comes just months after the pharmaceutical giant scrapped plans for a vaccine manufacturing plant in the same region. The implications of this move extend beyond financial figures, […]

Xpeng, the renowned Chinese electric vehicle (EV) manufacturer, is making waves in the European automotive industry with the inauguration of its first European production line in partnership with Magna Steyr, a leading Austrian vehicle contract manufacturer under the umbrella of Magna International. The strategic collaboration aims to leverage Magna’s state-of-the-art facilities in southern Austria to […]

In a groundbreaking move, XPeng Inc. (NYSE: XPEV) has forged a strategic partnership with Magna International Inc. (NYSE: MGA) to establish a production base for two distinct electric vehicle models within the European region. This collaboration marks a significant leap for XPeng as it ventures into the European market, with production slated to commence in […]

The semiconductor industry is currently experiencing a monumental shift driven by the strategic integration of artificial intelligence (AI). The recent insights shared at SEMICON Taiwan 2025 by experts from Microsoft, Advantech, and Nvidia shed light on the industry’s rapid transition towards “Lights-Out” factories – fully automated facilities operating round the clock, empowered by AI. This […]

Hyundai has recently entered into a groundbreaking partnership with biotech firm UNCAGED Innovations to pioneer animal-friendly and sustainable alternatives to traditional leather for car interiors. This collaboration, under the umbrella of Hyundai CRADLE, the innovation arm of Hyundai Motor Group, aims to develop a high-performance bioleather named “ELEVATE” that not only mirrors the quality and […]

Researchers at the University of California, Davis have been awarded a $3 million National Science Foundation grant to pioneer groundbreaking technologies and workforce training programs aimed at cultivating plants in resource-limited environments both on Earth and in space. The project, known as Engineered Plants in Culture (EPiC), seeks to revolutionize biomanufacturing by leveraging the industrial […]

In the dynamic realm of biomanufacturing, where innovation races ahead at breakneck speed, the infrastructure struggles to keep pace. The global capacity squeeze in this sector is a pressing issue, with a widening gap between the demand for cutting-edge biologics and the limited manufacturing capabilities available. As the complexity and diversity of biologic modalities expand, […]

Biocon Limited, India’s premier biopharmaceutical company, recently made a significant stride by inaugurating its first U.S. manufacturing facility in Cranbury, New Jersey, through its subsidiary, Biocon Generics Inc (BGI). This milestone marks a pivotal moment in Biocon’s global expansion strategy, solidifying its commitment to providing innovative healthcare solutions to patients worldwide. The facility, acquired from […]

Stryker, GE HealthCare, Alcon, and Arthrex have recently been honored by Fortune for their exceptional workplace environments, making it to the prestigious 2025 Best Workplaces in Manufacturing & Production list. These recognitions are a testament to the companies’ commitment to fostering trust, well-being, growth, and a positive culture among their employees. To earn a spot […]

In recent news, Wall Street experienced a significant rally fueled by hopes of potential interest rate cuts. This rally has sparked optimism among investors, leading to record-setting highs in the stock market. As a biotech manufacturing operations leader, it is crucial to analyze and understand the implications of such market movements on our industry. The […]

With the automotive industry rapidly transitioning towards electric vehicles, XPENG, a prominent Chinese smart electric vehicle manufacturer, has taken a significant step by partnering with Magna, a renowned Austrian contract manufacturer, to produce electric crossovers for the European market. The collaboration signifies a crucial move for Chinese car manufacturers aiming to establish a foothold in […]

In the realm of electric vehicles (EVs), the landscape is ever-evolving, with companies strategically maneuvering to optimize their production processes, address regulatory challenges, and expand their market presence. A recent development that has captured attention is the collaboration between Xpeng, a prominent Chinese carmaker, and Magna Steyr, a renowned contract manufacturer based in Graz, Austria. […]

In the realm of semiconductor manufacturing, a groundbreaking technique has emerged, promising to revolutionize the industry’s environmental impact and technological advancements. Researchers hailing from Japan and Taiwan have unveiled a halogen-free plasma etching method that boasts atomic-level precision, particularly in the etching of hafnium oxide (HfO2) films. This innovation, showcased in Small Science, signifies a […]

Western Carriers, a prominent logistics company based in Kolkata, is embarking on an ambitious expansion journey into new regions across India. The strategic focus is on areas where the demand for logistics services is particularly high, aligning with the company’s vision of growth and enhanced service offerings. Through a proactive approach, Western Carriers aims to […]

Introduction Artificial intelligence (AI) stands at the forefront of technological advancements, poised to revolutionize India’s economic landscape. A recent report jointly released by NITI Aayog and Niti Frontier Tech Hub unveils the immense potential of AI in propelling India towards its ambitious GDP target of $8.3 trillion by 2035. Titled “AI for Viksit Bharat: The […]

Governor Phil Murphy recently unveiled the state-of-the-art biomanufacturing facility of Enzene, a prominent global Continuous Innovative Development and Manufacturing Organization (CIDMO). This inauguration marks a significant milestone in the expansion of biotech capabilities in the United States, showcasing Enzene’s commitment to advancing pharmaceutical innovation and enhancing supply chain resilience in North America. The new facility, […]

In a groundbreaking development by the scientists at the Wadhwani School of Data Science & AI, IIT Madras, a revolutionary computational tool named COSMOS (Community and Single Microbe Optimisation System) has emerged. This tool stands poised to transform the way industries leverage microbial processes for sustainable production. By employing sophisticated simulations, COSMOS offers insights into […]

Welcome to the fascinating realm of additive manufacturing of ceramics for extreme environments, where scientific ingenuity meets industrial innovation to push the boundaries of material applications. In this exciting journey, we explore how ceramics, with their exceptional properties, are revolutionizing industries by withstanding extreme conditions that challenge conventional materials. From chemical reactors to aerospace components, […]

In a groundbreaking move towards revolutionizing healthcare, the UK government has allocated nearly £30 million to inaugurate a cutting-edge facility dedicated to propelling the development of novel RNA therapies. The establishment of the UK RNA Biofoundry, situated at CPI’s RNA Centre of Excellence in Darlington, signifies a significant leap forward in empowering UK scientists and […]

In the dynamic landscape of pharmaceutical manufacturing, Grand River Aseptic Manufacturing Inc. (GRAM) stands at the forefront of innovation and expansion with the recent appointment of Denis Johnson as the new CEO. With over 25 years of industry experience under his belt, Johnson steps into his role amidst a period of rapid growth and increasing […]

Indian biopharmaceutical company Biocon Limited reached a significant milestone on September 10, 2025, with the inauguration of its first manufacturing facility in the United States, located in Cranbury, New Jersey. The event was attended by New Jersey Governor Phil Murphy, Biocon Chairperson Kiran Mazumdar-Shaw, and industry representatives, signifying the strategic importance of this development. Operated […]

Introduction: In the realm of biotech manufacturing operations, the convergence of cutting-edge technology and operational excellence is paramount to success. One technology that has been gaining momentum and showing immense promise is focused ultrasound. This non-invasive therapeutic technology has the potential to revolutionize the way we approach various medical conditions. As a biotech manufacturing operations […]

In the intricate realm of clinical development within the manufacturing sector, the convergence of technology and data has birthed a new paradigm – Industrial DataOps. This avant-garde approach transcends traditional data management, infusing agile methodologies and automation to propel manufacturing processes into a realm of unprecedented efficiency and innovation. As a seasoned clinical development strategist […]

As a seasoned biotech manufacturing operations leader, you are well aware of the complexities and challenges involved in scaling up production to meet growing demand. In the fast-paced world of biotechnology, where innovation drives competition and market dynamics evolve rapidly, the ability to effectively manage plant capacity, mitigate batch failures, and optimize the supply chain […]

Electronics aficionados and tech enthusiasts, brace yourselves for an electrifying update from the dynamic world of Harmony Electronics! The whispers in the tech corridors have finally been confirmed – a change in leadership is on the horizon, coupled with the grand unveiling of a cutting-edge manufacturing facility. This monumental shift promises not just a new […]

In the intricate landscape of the life sciences industry, a paradigm shift is underway. The demands have intensified—ranging from compressing development timelines and meeting stringent regulatory requisites to delivering therapies that resonate with real-world patient needs. Over the years, endeavors to combat these challenges often took the form of isolated solutions, striving for marginal advancements. […]

India’s fight against malaria has reached a significant milestone with the licensing of multiple industry partners for the manufacturing and commercialization of its first indigenous multi-stage malaria vaccine. Developed by the Indian Council of Medical Research (ICMR) and its collaborators, this groundbreaking vaccine is designed to target the malaria parasite before it enters the bloodstream, […]

The semiconductor industry is currently experiencing a significant shift catalyzed by the strategic integration of artificial intelligence (AI). At SEMICON Taiwan 2025, industry stalwarts such as Microsoft, Advantech, and Nvidia shared profound insights into the sector’s rapid move towards “Lights-Out” factories. These fully automated facilities, operational round-the-clock and powered by AI, are poised to address […]

In a groundbreaking move that underscored its commitment to global expansion and innovation, Biocon Limited, a prominent Indian biopharmaceutical company, unfurled its inaugural manufacturing facility on American soil in Cranbury, New Jersey, on a momentous day, September 10, 2025. The ribbon-cutting event was graced by the esteemed presence of New Jersey Governor Phil Murphy, alongside […]

In the realm of large-scale biomanufacturing, the efficient management of process liquids and buffers is crucial for the successful production of biotherapeutics. As manufacturing processes transition from small-scale development to commercial-scale production, the sheer volume of liquids involved can present significant challenges. Directly scaling up buffer production in-house often leads to resource-intensive processes, space constraints, […]

In the realm of biotech manufacturing operations, the journey from concept to commercialization involves a myriad of challenges, particularly when scaling up production processes. As a biotech manufacturing operations leader, it is crucial to navigate the complexities of scale-up, scheduling, plant capacity, batch failures, and supply chain intricacies to ensure seamless execution at scale. Let’s […]

Boeing has set a new standard in aerospace manufacturing with the introduction of 3D-printed solar array substrates, a groundbreaking innovation that significantly reduces production timelines. This cutting-edge approach allows for the compression of composite build times by up to six months, marking a remarkable improvement of up to 50% compared to traditional manufacturing processes. By […]

In today’s rapidly evolving industrial landscape, the integration of digital twins and artificial intelligence (AI) has become a crucial strategy for factories looking to enhance efficiency, reduce downtime, and stay competitive in the market. This shift towards advanced technologies is particularly vital for established enterprises aiming to modernize their operations while safeguarding their existing investments […]

Akums Drugs & Pharmaceuticals recently achieved a significant milestone by obtaining the Good Manufacturing Practice (GMP) Certification from the Eurasian Economic Union (EAEU) for its hormonal manufacturing plant. This accomplishment opens up new avenues for the company to expand its reach into regulated international markets and reinforces the trust in its manufacturing capabilities. The demand […]

Glenn Wright, the President and CEO of PDA, shares his excitement and deep connection to the 34th Annual PDA Joint Regulatory Conference, highlighting the industry’s evolution and the collaboration between industry and regulators as a core aspect of the event’s success. With 36 years of involvement with PDA, Wright emphasizes the importance of the conference […]

The landscape of drug-related arrests in Central Illinois is shifting, particularly in relation to methamphetamines. Recent data has shown a concerning rise in methamphetamine-related arrests within Springfield and its neighboring areas. The Springfield Police Department has observed a surge in arrests linked to methamphetamines, encompassing charges associated with distribution, manufacturing, and possession. Sangamon County mirrors […]

In a significant development for New Zealand’s push towards sustainable transportation, Alstom India has secured a groundbreaking contract to manufacture the country’s first battery-electric multiple unit trains. These cutting-edge trains, branded as ‘Tuhono’, are set to revolutionize the country’s rail network by offering emission-free operations on non-electrified tracks. Let’s delve into the details of this […]

Mazagon Dock Shipbuilders Limited (MDL) is currently in the process of negotiating formal contracts with Indian procurement authorities for Project 75(I), a significant initiative focused on constructing six advanced conventional submarines. This partnership marks a pivotal moment in bolstering indigenous naval capabilities through the exchange of international technologies and strategic collaboration. The project entails the […]

Charter Next Generation (CNG) and NOVA Chemicals are joining forces in a groundbreaking partnership to introduce high-quality recycled polyethylene (rPE) into the realm of advanced flexible packaging applications. By coining the brand name SYNDIGO for their post-consumer recycled (PCR) resin, sourced from recycled film and plastic packaging, the collaboration is set to propel the industry […]

In the realm of biotech manufacturing operations, the journey from laboratory-scale production to large-scale commercialization is a complex and challenging endeavor. One of the key aspects of this transition is scale-up, which involves increasing the production capacity while maintaining product quality, consistency, and cost-effectiveness. As a biotech manufacturing operations leader, it is crucial to navigate […]

Biotech manufacturing operations encompass a wide range of critical activities, from scale-up and scheduling to plant capacity, batch failures, and supply chain management. As a leader in this field, it is essential to navigate through various challenges to ensure smooth and efficient operations at scale. Let’s delve into the key areas of focus and explore […]

Biotech manufacturing operations are complex and require meticulous planning to ensure successful scale-up, efficient scheduling, optimal plant capacity utilization, minimal batch failures, and robust supply chain management. As a biotech manufacturing operations leader, it is crucial to address key challenges and implement effective solutions to drive operational excellence and meet growing demands in the industry. […]

In the realm of biotech manufacturing operations, scaling up production while maintaining quality and safety is paramount. The successful manufacturing of biopharmaceuticals, such as antibody-drug conjugates (ADCs) used in breast cancer treatment, requires a deep understanding of structural components, toxicity profiles, and the nuances of managing batch failures and supply chain challenges. As we delve […]

The concept of green manufacturing has been greatly influenced by the emergence of 3D printing technology, which has been likened to a second industrial revolution. With its ability to transform various sectors such as automotive, healthcare, and construction, 3D printing offers a promising solution to reduce waste and improve manufacturing efficiency. The industry has experienced […]

As global climate regulations become stricter and the push to decarbonize intensifies, manufacturers are facing increased international requirements and evolving consumer demands. The European Union’s Carbon Border Adjustment Mechanism, coming into effect in 2026, will require South African manufacturers exporting certain products to provide verifiable emissions data or face obstacles in market entry. This poses […]

In the realm of biotech manufacturing operations, one of the critical challenges lies in scaling up production to meet increasing demand while maintaining efficiency and quality standards. As operations leaders, it is imperative to address various aspects such as scheduling, plant capacity, batch failures, and supply chain intricacies to ensure smooth execution at scale. When […]

As a biotech manufacturing operations leader, it is crucial to address key challenges such as scale-up, scheduling, plant capacity, batch failures, and supply chain management to ensure successful execution at scale. When considering the scale-up of biopharma production, it is essential to assess the capacity of the existing facilities and equipment to meet the increased […]

Eli Lilly has achieved significant milestones in its development of orforglipron, an oral obesity pill, following the successful Phase III ATTAIN-2 trial. The trial results have not only demonstrated substantial weight loss benefits but also highlighted a key manufacturing advantage that could lead to a substantial market opportunity for the company. With a weight reduction […]

Illinois has witnessed a significant surge in business investments, with over 700 companies committing to expanding or relocating to the state. These investments, totaling $25.8 billion in the last fiscal year, are poised to generate around 19,000 new jobs. The state’s focus on sectors like quantum computing, electric vehicles, and clean energy reflects a strategic […]

Taiwan Semiconductor Manufacturing (TSMC) has established itself as the go-to leader in producing cutting-edge chips, boasting significant free cash flow despite its aggressive expansion efforts in new fabrication facilities. While not as flashy as some AI giants like Nvidia or AMD, TSMC plays a crucial role by manufacturing chips for various chip designers, making it […]

Eli Lilly is on the verge of introducing the first widely available oral GLP-1 drug for weight loss, with their pill orforglipron set to undergo approval this year following promising results from a Phase 3 study. The study demonstrated substantial weight loss, A1C reductions, and improvements in cardiometabolic risk factors over a 72-week period among […]

Bio-Thera Solutions Inc., a biopharmaceutical company focusing on innovative therapies and biosimilars, has recently obtained European Commission (EC) approval for BAT2206, a biosimilar of Stelara, with marketing rights in Europe granted to Gedeon Richter under the brand name Usymro. This approval, following a positive evaluation by the European Medicines Agency’s (EMA) Committee for Medicinal Products […]

Abbott Laboratories, under the leadership of CEO Robert Ford, is actively preparing for the impact of increased tariffs, particularly the 50% levy on its imports from India to the US. Ford emphasized the lasting nature of tariffs once implemented, signaling the need for strategic adjustments within the company’s network. Despite facing nearly a $200 million […]

The adoption of artificial intelligence (AI) in pharmaceutical manufacturing has led to significant advancements in improving yield, batch consistency, and overall output. Drugmakers are increasingly integrating AI technologies across their manufacturing chains, encompassing upstream, downstream, and fill-finish processes to enhance efficiency and operational performance. While AI offers promising opportunities, it also introduces new risks and […]

Artificial intelligence (AI) is revolutionizing numerous industries by enabling cutting-edge applications that were previously unimaginable. From military drones to healthcare diagnostics and environmental conservation, AI is shaping the future in diverse ways. The rapid development of AI-powered tools played a crucial role in accelerating the timeline for COVID-19 vaccine development, showcasing the potential for AI […]

Digital twin technology integrated with AI is revolutionizing pharmaceutical manufacturing by enhancing efficiency and reliability. Collaborative efforts between CARES and A*STAR I2R have led to the development of a sophisticated system where the digital twin’s ontology and physical modeling are combined with an AI agent for anomaly detection. By merging physical and data-driven models, this […]

Lighthouse Pharmaceuticals has secured a significant $49.2 million grant from the National Institute on Aging (NIA) to progress the Phase 2 clinical trial of LHP588, a novel gingipain inhibitor targeting Porphyromonas Gingivalis. This inhibitor aims to combat neuroinflammation and neurodegeneration associated with Alzheimer’s disease by addressing potential microbial causes. The grant signifies a crucial step […]

Unifi, Inc., the company behind the Repreve fiber brand, faced a challenging fiscal fourth quarter with a 12 percent decline in sales, leading to a steeper adjusted loss. The primary reason cited for this decline was the uncertainty surrounding tariffs, causing customers to delay orders. The CEO, Eddie Ingle, highlighted the impact of recent tariff […]

Precision medicine has long been hindered by exorbitant costs, limiting patient accessibility to life-saving treatments for conditions like cancer. Multiply Labs Inc. has pioneered a groundbreaking approach to biomanufacturing by leveraging UR cobots, resulting in a remarkable 74% reduction in the production costs of personalized cell therapies. This innovation marks a significant shift from the […]

In the realm of manufacturing, the concept of Digital Twins has emerged as a game-changer, offering a versatile solution to streamline processes, enhance product development, and optimize operations. By providing a virtual replica of physical assets and processes, Digital Twins empower companies to gain valuable insights, anticipate challenges, and make informed decisions. Take, for instance, […]

In the biotech industry, scaling up manufacturing operations is a critical challenge that requires careful planning and execution to meet the escalating demand for advanced medical devices and therapies. As the global market for next-generation infusion pumps is projected to reach USD 9.3 billion by 2035, manufacturing leaders must address key factors such as plant […]

Takeda Pharmaceutical Company’s stock experienced fluctuations on Friday, with TAK stock initially dropping to $14.53 during premarket trading before recovering to $15.47 later in the day. This movement followed the U.S. FDA’s approval of Ionis Pharmaceuticals, Inc.’s Dawnzera for the prevention of hereditary angioedema (HAE) attacks in patients 12 years and older. Takeda also offers […]

In biotech manufacturing operations, scaling up production presents a myriad of challenges that require pragmatic solutions to ensure smooth execution. As operations leader, it is crucial to address key areas such as scale-up processes, scheduling, plant capacity, batch failures, and supply chain management to optimize manufacturing efficiency and product quality. One of the primary challenges […]

In the realm of biotech manufacturing operations, scaling up presents a myriad of challenges that require pragmatic solutions to ensure smooth execution at a larger capacity. One of the key aspects to consider is plant capacity – as production volumes increase, bottlenecks can emerge in the manufacturing process. Ensuring that the plant’s infrastructure, equipment, and […]

The results from recent trials of oral obesity candidates have left investors underwhelmed, with Eli Lilly’s orforglipron and Viking Therapeutics’ VK2735 failing to meet expectations. Analysts predict that weight loss pills may have a larger impact in low- and middle-income countries compared to the U.S., where injected peptides currently dominate the market. Despite the anticipated […]

Scaling up biotech manufacturing operations comes with its unique set of challenges that require careful consideration and proactive solutions to ensure smooth execution at scale. From managing plant capacity and scheduling to addressing batch failures and optimizing the supply chain, there are critical factors that must be taken into account to achieve operational success. One […]

Continuous biomanufacturing is poised for significant commercial expansion, driven by advancements in technology, regulatory support, and economic advantages in producing recombinant proteins and biosimilars. Analysts highlight the substantial benefits of continuous processes, including reduced equipment footprint by up to 70%, three- to five-fold increase in productivity, improved product quality consistency, and substantial facility cost reductions […]

The Kennedy College of Science, Department of Chemistry, is hosting a Ph.D. research proposal defense by Mahsa Aghaei on August 25, 2025. The focus of the research is on understanding the importance of disulfide bonds in maintaining the stability, activity, and safety of therapeutic proteins. Disulfide bonds play a crucial role in protein folding and […]

Columbia University researchers are pioneering a groundbreaking approach that leverages DNA to create intricate nanomaterials, inspired by nature’s bottom-up design principles. By programming DNA to form voxel-shaped scaffolds, the team can orchestrate the assembly of diverse nanoscale components, enabling the construction of complex 3D structures like light-reflecting crystals, miniaturized electronics, and brain-like circuits. This innovative […]

The recent FDA approval of Celltrion’s Avtozma biosimilar, a formulation of tocilizumab-anoh, for treating cytokine release syndrome (CRS) in both adult and pediatric patients marks a significant milestone in the realm of immunotherapy. This approval not only expands the indications covered by Avtozma IV, aligning it with the reference product Actemra IV, but also underscores […]

Plug Power Inc.’s stock has experienced a notable surge, attributed to Federal Reserve Chair Jerome Powell’s recent dovish remarks at Jackson Hole, signaling a potential shift towards growth equities amid speculation of interest rate cuts. Powell’s acknowledgment of rising downside risks to employment and the Fed’s readiness to adjust monetary policy in response to job […]

India and South Africa are poised to strengthen their partnership in the fields of food and healthcare, with more than 30 Indian companies gearing up to showcase their products at the upcoming Pharm Health South Africa and Food Show South Africa event in Johannesburg from August 27 to 29. The Deputy Consul General in Johannesburg, […]

SetPoint Medical’s recent achievement of securing $140 million in private financing to advance the commercial rollout of its SetPoint System underscores the increasing confidence investors have in neuromodulation approaches for treating autoimmune conditions. The SetPoint System targets the body’s neural pathways to modulate the immune response, providing a non-pharmacological therapy that could reduce reliance on […]

Construction Dive’s newsletter offers a valuable resource for staying updated on the latest news in the construction industry, delivered conveniently to your inbox. One of the significant highlights is AbbVie’s strategic move to expand its production capacity in the U.S., specifically with the construction of a new active pharmaceutical ingredient (API) plant in Illinois. This […]

WuXi Biologics, a prominent global Contract Research, Development, and Manufacturing Organization (CRDMO), has recently received approval from the European Medicines Agency (EMA) for its Dundalk, Ireland facility to engage in commercial manufacturing of an innovative biologic for a global client. This milestone approval further solidifies WuXi Biologics’ standing, with multiple facilities having obtained EMA and […]

Recent advancements in transistor design have paved the way for enhanced bio-integrated electronics, particularly through the development of stretchable, self-healing transistors. These cutting-edge components represent a significant stride in making implantable devices more adaptable to the natural movements of the human body. By utilizing materials that closely mimic the softness and flexibility of biological tissues, […]

The high potency API contract manufacturing market is on track to double its value by 2035, reaching USD 20.7 billion from USD 10.5 billion in 2025, with a projected compound annual growth rate (CAGR) of 7.0%. This growth is primarily attributed to the increasing incidence of chronic diseases, particularly cancer, and the expanding utilization of […]

CRB, a prominent provider of engineering, architecture, construction, and consulting services for the life sciences and food and beverage sectors, has recently named Eric Hanson as Senior Director in its Life Sciences division. With over 20 years of experience in biotechnology operations, facility design, and manufacturing, Hanson brings a wealth of expertise to CRB’s expanding […]

BioMADE, a Dept. of Defense-funded Manufacturing Innovation Institute, has revealed plans to construct a $40 million bioindustrial manufacturing facility near Ames, Iowa, marking its third major site alongside existing locations in Minnesota and California. This new plant, slated for a 2028 opening, aims to expedite the scale-up of agricultural bioproducts, chemicals, and food, bolstering domestic […]

Cell and gene therapy (CGT) manufacturing stands as a notably costly process, with a single batch of cell therapy often exceeding $500,000 in production expenses. The repercussions of a failed batch due to minor process deviations are substantial, leading to financial losses for manufacturers and treatment delays for patients. The CGT market is witnessing exponential […]

The Trump administration’s latest initiative, the FDA PreCheck program, aims to enhance domestic pharmaceutical manufacturing by streamlining the process of establishing manufacturing facilities in the U.S. This program, introduced as part of efforts to reduce reliance on overseas drug production, facilitates more frequent communication with the FDA in early stages and provides early feedback to […]

In response to the growing concerns over the dependence on foreign drug manufacturing, the FDA has launched the innovative PreCheck program. This two-phase initiative is designed to streamline facility approvals, reduce reliance on overseas pharmaceutical production, and enhance the resilience of the domestic drug supply chain. By fortifying regulatory processes and encouraging the establishment of […]

Peptides are essential building blocks of proteins, playing crucial roles in various biological functions. The process of peptide synthesis involves intricate steps like coupling reagents, protecting groups, and can be carried out through solid-phase or liquid-phase methods. In recent studies, scientists have uncovered surprising genetic origins among Samoan populations, shedding light on their unique heritage. […]

Biological technologies are showing immense potential in manufacturing products on-demand in space, benefiting from reduced power, volume, and launch mass requirements compared to conventional methods. This approach also allows for the utilization and recycling of available resources and materials, paving the way for sustainable production in space. Despite these advantages, challenges persist in adapting biological […]

In the realm of biotechnology, the convergence of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) is a pivotal aspect of ensuring the safety, efficacy, and quality of products developed for clinical research. GMP regulations are designed to ensure that pharmaceuticals, biologics, and medical devices are consistently produced and controlled according to quality standards. […]

Exciting news as the initiative to reduce the GMP clearance backlog kicks off in July 2025. Stay informed on the progress through the GMP clearance Sponsor Information Dashboard (SID) and updates shared with industry experts via the TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG). This strategic move aims to streamline GMP production processes […]

Exciting news from Almac Group as they announce their state-of-the-art GMP manufacturing and packaging capacity. With 2,000m² of customisable GMP floor space, Almac Group’s world-class facilities in the UK, Europe, and the US are MHRA, HPRA, and FDA approved. Stay ahead in the manufacturing industry with Almac Group’s cutting-edge solutions and expertise. Read more about […]