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Pharmaceutical Technology/BioPharm Marketplace eNewsletter

Pharmaceutical Sciences, Manufacturing & Marketplace Report June 26, 2013
  From Cynthia Challener, PhD, Editor, Pharmaceutical Sciences, Manufacturing & Marketplace Report
In this issue, the impact of FDA's recent guidance on Pharmaceutical Co-Crystals on API manufacturing and formulation development. Plus serialization regulations in California and the EU and pending legislation in the US. And the latest on single-use technologies in aseptic-filling systems and high-throughput glycan analysis. 		 
 

   
Stay current in the fast-paced world of biopharmaceutical and pharmaceutical development and manufacturing with a free subscription to the Pharmaceutical Sciences, Manufacturing & Marketplace Report.
 
Chemical API Manufacturing
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Alfred Pasieka/Getty Images

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. Click Here to Read More

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Parenterals
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Maria Toutoudaki/Getty Images
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. Click Here to Read More
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Pharmaceutical Analysis
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Adam Gault/Getty Images
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. Click Here to Read More
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Solid, Semisolid, and Specialty Dosage Forms
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Ion-Bogdan Dumitrescu/Getty Images

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?Click Here to Read More

Join our Solid, Semisolid, and Specialty Dosage Forms Linked-In Community
 
Biological API Manufacturing
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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. Click Here to Read More

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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.

 
Highlights from Pharmaceutical Technology and BioPharm International
Recent articles from Pharmaceutical Technology and BioPharm International

Solid Dosage

Experts Discuss Quality by Design (Equipment and Processing Report)

Making the effort to apply new methods to pharmaceutical processing will bring benefits.
Click Here to Read More

Parenterals

Lyophilization: A Primer (Pharmaceutical Technology)

Optimized freeze-drying cycles can offer scientific and business advantages. Click Here to Read More

Pharmaceutical Analysis

Compositing Samples and the Risk to Product Quality (Pharmaceutical Technology)

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied. Click Here to Read More

Chemical API Manufacturing

Using Thermal Ink-Jet Printing Technology to Produce Pharmaceutical Cocrystals (Pharmaceutical Technology)

Cocrystals are used to improve the performance of APIs that have non-ideal physiochemical properties. Click Here to Read More

Biological API Manufacturing

Facility Trends: Modularization and Single Use (Biopharm International)

BioPharm International spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.Click Here to Read More

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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