MARCH 2015
Volume 39, ISSUE 3 |
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|Focus|
Randi Hernandez
While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.
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|Featured content|
Andrew Teasdale, Cyrille C. Chéry, Graham Cook, John Glennon, Carlos W. Lee, Laurence Harris, Nancy Lewen, Samuel Powell, Helmut Rockstroh, Laura Rutter, Lance Smallshaw, Sarah Thompson, Vicki Woodward, and Katherine Ulman
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities. read more |
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Eric Bohn
Cleanability is crucial when choosing components for GMP manufacturing areas. read more |
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|Peer-reviewed research|
P.J. Cullen
The pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature.
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|FORMULATION|
Adeline Siew, PhD
While the skin offers an alternative route of administration for local and systemic drug delivery, developing semi-solid dosage forms can be a challenge.
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|API SYNTHESIS & MANUFACTURING|
Cynthia Challener, PhD
Protecting workers, patients, and the environment requires advanced technologies.
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|TROUBLESHOOTING|
William Evans
Several chromatographic resins are available for downstream purification.
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|OUTSOURCING OUTLOOK|
Eric Langer
Is there enough talent to go around?
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|Regulatory Watch|
Jill Wechsler
Scientists and industry experts seek effective preventive therapies to combat global disease.
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Sean Milmo
Proposals to make the decentralized procedure more efficient were discussed at the January 2015 EGA conference.
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|OTHER FEATURES|
Dale Schmidt, PhD, Anita Y. Szajek, Fouad Atouf, PhD, and Tina S. Morris, PhD
A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
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Susan J. Schniepp
A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.
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Jim J. Zhang, PhD
The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.
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Siegfried Schmitt
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses good engineering practices.
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Rita Peters
Sessions address cell therapies, tableting, continuous processes, serialization, and more.
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Richard Grant, Global VP of Cell Therapy at Invetech discusses the advantages and challenges of developing and manufacturing personalized immunotherapies.
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|Webcasts|
March 25, 2015 at 11 am ET | Live Webcast
Learn basics of water activity and the role it plays in the chemical stability, microbial content, and physical properties of pharmaceutical products. Hear experts discuss compendial and regulatory requirements for water-activity determination, and practical applications of water activity in marketed pharmaceuticals.
Sponsored by: Decagon Devices
On Demand
Softgel expert, Kaspar van den Dries talks about the opportunities for formulating products with softgel technologies for pediatric, adult and elderly population. Learn about registration of a generic chewable softgel for pediatric indication.
Sponsored by: Patheon
more webcasts
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|on pharm tech tv|
Challenges in Maintaining the Cold Chain
Prefilled Syringes for Clinical Trial Use
Child-Resistant, Senior-Friendly Packaging
Cross-Contamination Risk in Manufacturing of Highly Potent Drugs
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|Events|
April 21–23, 2015 | New York
April 27–29, 2015 | Philadelphia, PA
April 27–29, 2015 | San Juan, Puerto Rico
more events
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