Search results for " Center of Excellence"
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
Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…
Article
Next Generation Bioprocesses: Mapping Roads to the Future
Increased productivity demand and a diversifying clinical drug pipeline have pushed the industry to explore new strategies and technologies in biomanufacturing. So what are next-generation proc…
Article
Modeling the Degradation of mAb Therapeutics
Acknowledgments
This work was funded by the Center of Excellence for Biopharmaceutical Technology grant from the Indian government’s department of Biotechnology (number BT/COE/34/SP15097/2015).
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Article
Industry Adoption of Single-Use Systems Remains Low
…e fast scale-up to 500 L initially and later to the 2000-L scale single-use bioreactor at Abzena’s center of excellence for clinical manufacturing.
The role of modular manufacturing
M…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
Article
The New World of Biopharmaceutical Manufacturing
Galliher, chief technology officer, Upstream, Cytiva; Sabrina Restrepo, associate director in the Sterile & Validation Center of Excellence, Global Technical Operations at Merck; Helene Pora, PhD, vic…