Search results for "biopharm" in Articles / App Notes
Article
Bracing for a Future Wave of Advanced Therapies
Buoyed by the regulatory approval of several cell and gene therapy (CGT) products for difficult-to-treat diseases, the US biopharma industry is now bracing for a new wave of CGTs in the near future as…
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Evolving demands of process development services
In this interview, BioPharm International discusses how process development demands have changed for service providers with Xiaoyong Fu, PhD, chief technology officer and head of API Business, WuXi ST…
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Enhancing Resins Addresses Purification Concerns
…o be produced quicker than traditional vaccines, confirms Nandu Deorkar, vice-president of R&D, Biopharma Production, Avantor.
The main critical purification challenge for mRNA-based vaccin…
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Understanding Validation and Technical Transfer, Part 3
This third article in a three-part series (1,2) dealing with validation and technical transfer in the biopharmaceutical industry discusses validation of a non-traditional biopharmaceutical process, l…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
The good news is that, partly because of the efforts to remove or inactivate viruses, there have been no reported cases of disease transmission from a biopharmaceutical manufacturing process to a pati…
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mAbs to Watch in 2016
And there may be many more of these types of proteins on the horizon—as many as 14 are projected to hit the market in 2016, according to data compiled by EvaluatePharma, in collaboration with BioPharm…
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Breakthrough Drugs Raise Development and Production Challenges
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA program to expedite the development and approval of innovative drugs for serious and life-threat…
Article
Robust Optimization, Simulation, and Effective Design Space
Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
…
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Taking a “Development-by-Design” Approach to Cell Therapies
A new CEO, David Mazzo, with a doctorate in analytical chemistry and experience running both private and public international biopharma companies, assumed NeoStem’s leadership in January. He sees no c…
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Quality Systems Key to Lifecycle Drug Management
FDA officials plan to try again to offer regulatory relief in filing supplements and also in undergoing plant inspections for those biopharma companies that implement QbD and advanced manufacturing te…