Search results for "biopharmaceutical"
Article
Bioprocessing Advances in Vaccine Manufacture
Single-Use Adoption
BioPlan's 10th Annual Report documents increasing adoption of these technologies and their impact on biopharmaceutical manufacturers. Survey data show that bioprocessing at pre…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
Twelve biopharmaceutical marketing applications were approved in the United States and/or the European Union in 2012 (see Table I). Approval numbers for the past year are in line with those recorded o…
Article
Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
Article
PDA's Technical Report for Biotech Cleaning Validation
Cleaning validation plays an important role in reducing the possibility of product contamination from biopharmaceutical manufacturing equipment. It demonstrates that the cleaning process adequately an…
Resource
Biopharm International
We provide practical peer-reviewed technical solutions to enable biopharmaceutical professionals to perform their jobs more effectively.
Article
Considerations in depth filter scale-up
Depth filters are widely used in the biopharmaceutical industry. They are typically made of a mixture of cellulose, filter aids, and a binder. These components can be milled and mixed in diffe…
Article
Selected courses from cell culture and downstream process development to scale-up and manufacturing
Built upon our expertise in the biopharmaceutical and biotechnological industry, our course curricula cover theory, applications, instrument use, process development and software.
Examples of avai…
Webcast
Accelerate biotech process development
Balancing innovation, speed, and robustness to support biotherapeutic production
Biopharmaceutical process development faces new challenges: shorter time-to-market and changing regulatory expect…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
…y compared to the reference product, says Olaf Stamm, PhD, technical business development director, Biopharmaceutical Testing Solutions, Charles River Laboratories.
Among these criteria are compa…
Article
Introducing the VH3 ligand ELISA kit
Ensuring the safety and efficacy of antibody-based therapeutics is crucial in biotherapeutic manufacturing. Accurate testing for ligand leakage from affinity resins is a key part of this proce…