Search results for " packaging"
Article
Understanding Validation and Technical Transfer, Part I
…visions, authorized FDA to issue good manufacturing practice (GMP) regulations for “manufacturing, packaging, or holding of finished pharmaceuticals.” Those regulations were finalized in 1963 as 21 C…
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
Bioburden Control in the Biopharmaceutical Industry
The basic standards for establishing a facility for manufacturing, processing, and packaging biopharmaceutical products should, therefore, ensure that these three criteria are met …
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
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
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Article
Single-use Bioreactors Have Reached the Big Time
“For example, Pall’s SU bioreactors come with special packaging and an easy-to-implement biocontainer installation method that eliminate the main causes of integrity failures,” she says.
Suppliers…
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
Drug Quality Key to Innovation and Access
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US health…
Article
The Tide Stays High
…s that cater to clinical development (clinical supplies manufacturing, analytical services, clinical packaging, and clinical research). Many CDMOs have told PharmSource that they are operating near c…
Article
Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO.
By Jim Miller
While industry participants and observers talk about the “CMO industry,” they know that …