| November 2015, Volume 11 Issue 11
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API Synthesis and Manufacturing
In the ongoing search for better fluorinating reagents, solid reagents and new coupling reactions are showing promise.
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Hovione acquired a formulation facility adjacent to its current process chemistry and particle engineering facility in Loures, Portugal.
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Bioprocessing and Sterile Manufacturing eBook
Articles in Pharmaceutical Technology’s Bioprocessing and Sterile Manufacturing ebook examine novel technologies for the development, manufacture, purification, and delivery of small- and large-molecule drugs, including single-use systems, lyophilization, and microbial monitoring. Aging facilities and the future of aseptic processing are featured topics.
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A collaboration between Grace and Formac Pharmaceuticals results in drug delivery options for poorly-soluble APIs.
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The technology offers full enteric protection of sensitive APIs without the need for functional coatings.
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The Transform film from Lubrizol LifeSciences is compatible with a range of APIs.
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Excipients Update
Representatives of the excipients industry responded to FDA’s request with new ways to make the IID more relevant and useful.
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Dow’s AFFINISOL HPMC HME is a new cellulosic polymer designed to enhance solubilization and inhibit recrystallization of APIs in hot-melt extrusion formulations.
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Parteck SRP 80 is a functional excipient designed for sustained-release matrix tablets.
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Ashland presented science-based strategies to enhance pharmaceutical formulation quality and advance drug delivery at AAPS 2015.
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Croda Choques SAS has become the company's third excipient manufacturing site, and the 24th such site worldwide, to receive certification.
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Outsourcing Update
While biologic drug development grabs investor interest, small-molecule APIs still hold two-thirds of the drug-development pipeline.
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The contract manufacturing landscape is morphing in response to new client demands and regulatory policies.
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Contract Services Update
Althea is expanding its existing biological drug-product manufacturing operations to include highly active materials, such as antibody-drug conjugates, in a new facility near San Diego, CA.
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CDMO Aesica Pharmaceuticals launched a new brand identity that reflects the new alignment and consolidation of the Consort Medical group and a new service to manage other CDMOs.
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CDMO Xcelience opens new facility in Tampa, FL, for formulation and analytical services.
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Supply Chain Update
Citing compliance issues, FDA has extended the deadline for product tracing information requirements for dispensers to March 1, 2016.
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Paxton will lead the Rx-360 mission to protect patient safety, and ensure the integrity of the healthcare supply chain and the quality of materials within the supply chain.
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Catalent Pharma Solutions announced plans to quadruple the cold-chain capacity at its existing clinical supply storage and distribution facility in Shanghai, China.
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