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Pharmaceutical Sciences, Manufacturing & Marketplace Report July 10, 2013
  From Cynthia Challener, PhD, Editor, Pharmaceutical Sciences, Manufacturing & Marketplace Report
In this issue, experts from Novo Nordisk and Baxter discuss technology advances to resolve the challenges of extractables and leachables. Also, researchers from BoehringerIngelheim report on recent work in asymmetric synthesis. GE Healthcare  and Bio-Manguinhos/Fiocruz advance large-scale plant-based protein production. And insight on X-ray imaging technology for QA/QC in manufacturing and risk-mitigation approaches in facility design and operation for high-potency solid dosage manufacturing. 		 
 

   
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Parenterals
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Experts from Novo Nordisk, Baxter Discuss Technological Advances in Addressing the Challenge of Extractables and Leachables

Understanding the supply-chain challenge and coupling high-efficiency chromatographic techniques with information-rich detectors are leading to improvements in the management of extractables and leachables in parenteral drugs. Click Here to Read More

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Chemical API Manufacturing
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New Chiral Sulfur and Phosphorous Chemistry from BoehringerIngelheim

New routes enable the efficient synthesis of enantiopuresulfinamides and structurally and sterically diverse P-chiral phosphine oxides. Click Here to Read More
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Biological API Manufacturing
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GE Healthcare, iBio, and Bio-Manguinhos/Fiocruz Advance Large-Scale Plant-Based Protein Production

GE Healthcare's partnerships with iBio and Brazil's Bio-Manguinhos/Fiocruz for a new plant-based multipurpose biopharmaceutical and vaccine manufacturing facility move plant-based protein production to the next level. Click Here to Read More
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Pharmaceutical Analysis
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Addressing Manufacturing Challenges with Nondestructive X-Ray Imaging

Greater sophistication in 3D X-ray imaging technology raises its utility for QA/QC in manufacturing.Click Here to Read More

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Solid, Semisolid, and Specialty Dosage Forms
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Technology Choices in Highly Potent Solid Dosage Manufacturing

Risk management guides decisions in facility design and operation for highly potent drugs. Click Here to Read More

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Other Recent Developments

Track-and-Trace Compliance Looming, but Once Implemented Will It Bring Benefits?
Serialization regulations in California and the EU come into effect in 2015 and 2016, and two US federal bills are moving through Congress. What are the implications for the pharmaceutical industry?

Aseptic Filling is the Next-Generation Application for Single-Use Systems
The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.

New High-Throughput Glycan Analysis Improving Cell-Line Selection and Early Bioprocess Development
Until recently, glycan analysis has been a slow, labor-intensive process more widely used late in bioprocess development. New high-throughput methods are changing that.

Cocrystals Can Improve API Properties, But Will the Recent FDA Guidance Slow Adoption of This Technology?
Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.

Fujifilm Diosynth Biotechnologies in an Expansion Mode
Since its inception in 2011, Fujifilm Diosynth Biotechnologies has added capabilities and single-use production capacity for mammalian-derived product manufacturing, upgraded development and pilot-scale microbial laboratories, and installed advanced analytical instrumentation.

 
On-Demand Webcast

USP Outlook: Key Program Activity for 2013

USP standards for the identity, strength, quality, and purity of medicines are an integral part of drug development and manufacturing. Modernization of USP monographs and development and revisions to General Chapters is a top priority for the USP Pharmacopeial Convention in 2013. In this webcast, USP experts provide the status and progress of these efforts: Monograph Modernization progress; New General Chapter content for Excipients, Analysis of Elemental Impurities, and Microbiology; and the latest on the Medicines Compendium.
Register for the on-demand webcast.

 
The Pharmaceutical Sciences, Manufacturing & Marketplace Report is a biweekly newsletter of Pharmaceutical Technology and BioPharm International, and an exclusive feature of the new Pharmaceutical Technology/BioPharm International Marketplace, an online community focused on products and services for drug development and manufacturing. The Pharmaceutical Sciences, Manufacturing & Marketplace Report provides insight in five main communities: solid, semisolid, and specialty dosage forms; parenterals; chemical API manufacturing; biological API manufacturing; and pharmaceutical analysis.  
 
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Perspectives from Cynthia Challener, PhD, editor of the Pharmaceutical Sciences, Manufacturing & Marketplace Report and industry members
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