Establishing Process Design Space for a Chromatography Purification Step: Application of Quality-by-Design Principles
This case study reviews how quality-by-design principles can be implemented in an intermediate chromatography purification step that uses cation-exchange chromatography.Abstract
Selecting the Right Viral Clearance Technology
Whether taking an upstream, downstream or holistic approach, there are many factors to consider when choosing viral clearance methods.
Best Practices for Sterility Assurance in Fill/Finish Operations
Two experts discuss best practices to achieve acceptable sterility assurance levels for aseptically filled products.
Diversifying the Global Heparin Supply Chain: Reintroduction of Bovine Heparin in the United States?
The global supply chain for bovine and porcine heparin and regulatory considerations are examined.
CMOs Continue to Improve Overall Biomanufacturing Performance
Better process development is creating industry benchmarks for bioprocessing.
FDA Overhauls Inspection Operations
New program emphasizes quality, risk, and global collaboration.
Good Documentation Practice: Saving Data for the Long Term
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.
Next Steps in Outsourcing Relationships
Biopharma and contract providers must tread carefully amid changing market dynamics.
Investigating Biologics
The authors discuss performing investigations of biological products.
Piloting Track-and-Trace Implementation
Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.
The Development of Process Chromatography in Bioprocessing
Industry experts discuss the development of process chromatography in bioprocessing.
Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis.
BioPharm International, November 2015 Issue (PDF)
Click the title above to open the BioPharm International November 2015 issue in an interactive PDF format.
