Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
The Human Factor in Inspections
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
Development of a Technique for Quantifying Protein Degradation
This article demonstrates that a modified SDS–PAGE can be easily used as a tool for quantifying the degree of protein degradation.
Leveraging Data Analytics Innovations to Improve Process Outcomes
New data analytics tools help solve complex problems in a biotherapeutic development process.
Achieving Optimal mAb Titer and Quality Through Cell Culture Media and Supplement Optimization
In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
Optimization of Culture Conditions for Expression of Human Interleukin 11
To investigate the best culture conditions, the authors used response surface methodology via Box-Behnken design.
Five Themes That Will Drive the CMO Industry
CMO executives are focusing on M&A activity, new business models, and fundraising limits.
Commercializing High-Concentration mAbs
The development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.
Managing Risk in Raw Material Sourcing
Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.
The Truth Behind Protein Aggregation in Prefilled Syringes
Interactions between biologic drug products and the components of prefilled syringes can cause protein aggregation, but there are alternative materials that can help mitigate this problem.
BioPharm International, November 2016 Issue (PDF)
Click the title above to open the BioPharm International November 2016 issue in an interactive PDF format.
