Search results for " collaboration"
Article
Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
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Poster
Rapid Process Development of a CIEX Step for a Biosimilar
When establishing purification processes for a biosimilar molecule it is important to develop steps that are scalable, selective, and cost-effective.
A cation exchange (CIEX) chromatographic ste…
Article
Current Innovations and Practices To Address Microbial Contamination in Downstream Bioprocessing
Bioburden control is an area of serious concern for anyone making mAbs or other biologicals. Manufacturers’ efforts to avoid microbial contamination are today being complemented by development…
Article
Work from Anywhere and Add Flexibility to Protein Purification Workflows
…ontrol capabilities to support:
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Freedom to operate from anywhere
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Efficient collaboration with colleagues
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Increased system utilization
Learn how to utilize …
Article
The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
By Jennifer Markarian
…
Article
From Darwin to Recombinant Fc Multimers
Interestingly, the Nordic countries have so many similarities and have many close collaborations, but have major differences in the welfare system and supply of critical plasma products. von Bonsdorff…
Article
Managing Residual Impurities During Downstream Processing
USP, in collaboration with its Expert Committee and Panel members, develops public standards that support the development, characterization, and release of therapeutics. USP monographs and associated …
Article
Drug Quality Key to Innovation and Access
A growing collaboration involves GMP inspections of APIs by FDA and regulatory authorities in Europe, Japan, Australia, Canada, and by the World Health Organization (WHO). FDA and the European Medicin…
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
Article
Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…