Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
Protein Impurities Pose Challenges
Multiple methods are required for detecting and removing protein impurities.
All Buzz, No Bite
Congressional partisanship creates noise, but no funding for Zika virus research.
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
Quality Manufacturing Key to Stemming Drug Shortages
Regulators and manufacturers address economic and ethical issues for scarce medicines.
Downstream Processing Continues to Worry CMOs
CMOs are working hard to improve performance by investigating new technologies for filtration and purification.
One Strategy for Updating an Aging Facility
Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.
Integrating Single-Use Systems in Biopharma Manufacturing
Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.
The Flexibility of Small-Scale Single-Use Bioreactor Solutions
The authors present a case study in which four single-use vessels were fitted to an existing bioreactor system.
Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody
The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.
Micro-Scale Bioreactors in Fed-batch Microbial Screening
The author outlines key functional attributes to assess a small-scale model.
Syringe Pump for Continuous Flow Chemical Processing
The Titan Syringe Pump from Syrris is a continuous flow chemical processing module suitable for lab-, pilot-, and production-scale applications.
Sterile Bag Streamlines Environmental Monitoring Workflows
The IsoBag from MilliporeSigma is used for the convenient transfer of contact and settle plates to production isolators.
BioPharm International, August 2016 Issue (PDF)
Click the title above to open the BioPharm International August 2016 issue in an interactive PDF format.
