Onyx Scientific, a division of Ipca Laboratories focusing on small molecule drug substance development, recently announced a significant expansion of its solid form and material science capabilities. This initiative, timed with the company’s 25th anniversary at the end of 2025, marks a major step forward in its mission to provide flexible, phase-appropriate development solutions, especially for complex molecules categorized under the Developability Classification System (DCS) classes II and IV.
Strategic Investment in Advanced Capabilities
The expansion comes in response to an increased demand for integrated services in crystallization development, particle engineering, and preformulation support. By enhancing its toolkit, Onyx aims to address the needs of clients from early-phase development through to commercial supply. This strategic investment is designed to streamline processes and improve the quality of outputs.
Cutting-Edge Technology for Real-Time Insights
At the heart of this development is the Technobis Crystalline PV/RR Line, an advanced platform that integrates temperature and turbidity measurements along with in-line particle imaging. This innovative technology provides real-time visualization capabilities, allowing for detailed insights into nucleation and crystallization behavior, as well as slurry conversions. Chris Atherton, the commercial director at Onyx Scientific, emphasizes the importance of this investment, stating that it enables the company to guide clients more effectively in early-phase material selection and optimization.
Building on Existing Foundations
The new platform complements existing assets such as the Crystal16 parallel screening system and Radleys Mya Station. With the addition of these new capabilities, Onyx Scientific aims to enhance preformulation screening and refine design spaces. This will facilitate the preparation of both small- and large-scale demonstration batches, which are critical for internal evaluations and collaborations with external partners.
Expansion of Processing Platforms
In addition to the Technobis Crystalline system, Onyx has acquired three new platforms that significantly enhance its capabilities in spray drying, lyophilization, and jet milling. These new tools include:
- Buchi S300 Mini Spray Dryer: This platform allows for the preparation of amorphous solid dispersions and supports agglomeration studies through its inert loop and ultrasonic nozzle.
- Buchi Lyovapor L-250 Pro: Equipped with manifold and shelf configurations, this system supports lyophilization processes for both aqueous and organic systems.
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MC DecJet 30 Jet Mill: This versatile equipment facilitates scalable micronization from milligrams to hundreds of grams, catering to applications such as inhalation and bioavailability enhancement.
Julian Northen, the technical director at Onyx Scientific, highlights the importance of these tools for delivering tailored batches that meet the specific needs of clients. The ability to produce small-scale, high-quality engineering batches is essential for supporting pharmacokinetic (PK), toxicity (tox), and first-in-human (FIH) programs.
Optimizing Solid-State Performance
With its enhanced capabilities, Onyx can now prepare amorphous materials in various formats, optimize particle sizes, assess dissolution behavior, and monitor amorphous content across multiple presentations. These advancements empower early-phase formulation teams to refine candidate compounds more quickly, with improved control over solid-state performance parameters.
Commitment to Continuous Improvement
Looking ahead, Onyx Scientific is preparing for additional upgrades in early 2026, including enhancements to its X-ray Powder Diffraction (XRPD) suite, which will incorporate non-ambient measurement capabilities. This commitment not only supports internal skill development and productivity improvements but also aligns with a long-term strategy to enhance the company’s solid-state offerings.
The Philosophy Behind the Expansion
Northen encapsulates the philosophy driving this expansion by stating that robust material science is foundational to successful drug development. Onyx Scientific is not merely investing in tools; it is investing in the expertise and insight necessary to effectively leverage these advancements.
Onyx Scientific continues to solidify its position as a leader in the small molecule CDMO space, driven by a commitment to innovation and excellence in material science.
Key Takeaways
- Onyx Scientific is expanding its solid form and material science capabilities to meet growing client demands.
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The introduction of advanced technologies like the Technobis Crystalline PV/RR Line enhances real-time insights into crystallization processes.
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New processing platforms for spray drying, lyophilization, and jet milling bolster the company’s ability to deliver tailored development solutions.
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Continuous improvements in technology and expertise underscore Onyx’s commitment to successful drug development.
In conclusion, Onyx Scientific’s strategic expansions position the company for future growth, ensuring it remains at the forefront of the biotech landscape. By integrating cutting-edge technology and enhancing its material science capabilities, Onyx is poised to meet the evolving needs of the pharmaceutical industry.
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