APRIL 2015
Volume 39, No. 4 |
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|Focus|
Jennifer Markarian
Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.
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|Featured content|
M. Sebastian Escotet-Espinoza, Ravendra Singh, Maitraye Sen, Thomas O'Connor, Sau Lee, Sharmista Chatterjee, Rohit Ramachandran, Marianthi Ierapetritou, and Fernando Muzzio
In-silico design facilitates process optimization and evaluation of process control strategies. read more
Randi Hernandez
In this article, industry experts discuss critical analyses for demonstrating biosimilarity. read more
Mark Mitchell
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. read more |
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|PEER-REVIEWED RESEARCH|
James Agalloco
The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.
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|FORMULATION|
Adeline Siew, PhD
Emerging controlled-release technologies could lead to more effective therapies in the near future.
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|API SYNTHESIS & MANUFACTURING|
Cynthia A. Challener
New legislation and changes in policy at FDA are leading to better control of the API supply chain.
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|TROUBLESHOOTING|
Katriona Scoffin
Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.
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|OUTSOURCING OUTLOOK|
Jim Miller
Big service providers get bigger faster thanks to Big Pharma.
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|REGULATORY WATCH|
Jill Wechsler
More reliable operations would accelerate product development and prevent drug shortages.
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Sean Milmo
Drug developers understand the importance of early communication with regulators, but is EMA providing enough flexibility and support to companies?
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|OTHER FEATURES|
Hallie Forcinio
Industry awaits the final revision of USP General Chapter <1207> and the impact it will have on the evaluation of sterile product package integrity.
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Jane Wan
Hope abounds for local drug discovery companies despite challenges at home.
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Rita Peters
FDA approves a biosimilar and loses a commissioner in March.
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David Barrett, chief operating officer at cut-e, discusses The Behavioral Positioning System.
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|Webcasts|
Thursday, May 14, 2015, 11 am EDT/8 am PDT/16:00 BST/17:00 CEST
Join this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
Register Free
Sponsored by: Eurofins Lancaster Laboratories
On Demand
As the biologics market continues to grow with additional launches, expanding indications, and approvals of biosimilars, the delivery platform will play a more critical role in product differentiation. Join us for this webinar to explore the advantages, challenges, case studies and science behind delivering biologics with a difference.
Sponsored by: Baxter BioPharma Solutions
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|Events|
April 21-23, 2015 | New York
June 01–03, 2015 | Washington, DC
June 02–04, 2015 | Philadelphia, PA
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