Great Expectations from New European Commission
The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.
Analyzing Protein Aggregation in Biopharmaceuticals
Understanding and preventing protein aggregation is crucial to ensuring product quality and patient safety.
Raw Materials and the Development Cycle
Switching grades of raw material late in the development cycle can be costly. Best practice says get it right at the beginning.
Fill/Finish Capacity Use for Biologics
There are significant differences between small molecules and biologics fill/finish capacity.
Politics and Patients to Shape Pharma in 2015
Manufacturers are under pressure to develop pipelines, promote quality, and justify pricing.
Standards Organizations Update
In late 2014, standards organizations continued to work towards harmonization and securing drug safety.
Adopting the Product Lifecycle Approach
The author presents opportunities and challenges in implementing the product lifecycle approach.
Ligand-Binding Assays and the Determination of Biosimilarity
Ligand-binding assays are fundamental to characterizing biosimilars.
Drug Breakthroughs, with Some Reservations
New designations lead to faster drug approvals, but there is more work to be done.
Technologies and Practices Must Evolve to Meet Demand
As more biologic drugs come to market, manufacturers will require improved bioprocessing technologies.
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth.
Sterile Vent Increases Precision
Bioreactor Enhances Process Control
Aseptic Robot Decreases Cycle Time
Chromatography Resin Purifies Proteins
BioPharm International, January 2015 Issue (PDF)
Click the title above to open the BioPharm International January 2015 issue in an interactive PDF format.
