Search results for " biopharmaceuticals"
Article
Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…
Resource
Biopharm International
BioPharm International magazine integrates the science and business of biopharmaceutical research, development and manufacturing. We provide practical peer-reviewed technical solutions to enable bio…
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
Develop your skills and those of your teams with training courses designed for researchers, process development scientists, engineers, and manufacturing operators.
Built upon our expertise…
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
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
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…