The landscape of fill/finish for mRNA vaccines presents unique challenges for CDMOs. These challenges include the need for capabilities to formulate and supply lipid nano particles (LNP) for mRNA encapsulation, as well as the criticality of cryo-handling. CDMOs face the additional complexity of meeting seasonal availability requirements for mRNA vaccines, which contrasts with steady monthly […]
Tag: Biologics
Zydus Lifesciences Enters Global Biologics CDMO Sector
Zydus Lifesciences is poised to make a significant entry into the global biologics CDMO business through the acquisition of US-based Genus Inc. This move aligns with Zydus’ strategic vision in biologics and their commitment to developing innovative solutions for unmet medical needs, particularly in the field of immuno-oncology. The collaboration with Agenus, a key player […]
Samsung Biologics’ Spin-Off Plan Sparks Stock Volatility
Samsung Biologics’ announcement to split into a contract drug manufacturer and a holding company has caused fluctuations in C&T shares. This move signals a significant restructuring within South Korea’s largest conglomerate. The plan aims to streamline operations by separating the manufacturing arm from the oversight and management functions, potentially enhancing overall efficiency and focus in […]
FDA, CDC Actions Impact COVID-19 Vaccine Coverage
In a commentary by FDA Commissioner Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH, the FDA’s approach to Covid-19 vaccines balances regulatory flexibility with gold-standard science. Trials will focus on high and low-risk individuals, shaping future FDA decisions and meeting healthcare provider and public needs. This strategy aims to ensure vaccine safety and efficacy […]
HT-KIT Activity in Rare KIT-Driven Cancers
Hoth Therapeutics is progressing HT-KIT towards clinical evaluation, aiming to submit an investigational new drug application to the FDA in early 2026. An investigational new drug application is a request for FDA authorization to administer an investigational drug to patients. This step is crucial before administering any new drug not yet approved through a new […]
Enhancing Recombinant Protein Production with EffiX System
WuXi Biologics introduces the EffiX E coli expression system to boost the production of recombinant proteins and plasmid DNA. This innovative system is designed to optimize the expression of nanobodies, providing a more efficient and cost-effective solution for biotechnological applications. EffiX offers a streamlined approach to generating high yields of target proteins, benefiting industries reliant […]
India’s Biologics Manufacturing Leadership
India has a significant opportunity to lead in the transition from generics to biologics by focusing on building capacity for next-generation biologic modalities and securing access to essential inputs. Biologics such as cell and gene therapies, monoclonal antibodies, antibody-drug conjugates, and nucleic acid-based treatments rely on a complex array of components like expression vectors, engineered […]
Agenus, Zydus Lifesciences Collaborate to Advance Biologics Manufacturing
Agenus and Zydus Lifesciences have entered a $141M strategic collaboration to advance their BOT/BAL programs and expand Zydus’ biologics manufacturing in the US. Forward-looking statements in this press release highlight the companies’ botensilimab and balstilimab programs, expected regulatory timelines, and filings. It is crucial to note that these statements are subject to risks and uncertainties […]
Zydus Strengthens Biologics Presence Through Agenus Deal
Zydus has solidified its position in the global biologics market through the acquisition of Agenus, which includes biologics manufacturing sites in Emeryville and Berkeley, California. The deal involves an upfront payment of $75 million, with an additional $50 million in milestone-based payments over three years. These facilities will support Zydus’ new biologics CDMO business, catering […]
