BioPharm International-08-01-2016

September 01, 2016

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.

August 01, 2016

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.

August 01, 2016

Multiple methods are required for detecting and removing protein impurities.

August 01, 2016

Congressional partisanship creates noise, but no funding for Zika virus research.

August 01, 2016

A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.

August 01, 2016

Regulators and manufacturers address economic and ethical issues for scarce medicines.

August 01, 2016

CMOs are working hard to improve performance by investigating new technologies for filtration and purification.

August 01, 2016

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.

August 01, 2016

Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.

August 01, 2016

The authors present a case study in which four single-use vessels were fitted to an existing bioreactor system.

August 01, 2016

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

August 01, 2016

The author outlines key functional attributes to assess a small-scale model.

August 01, 2016

The Titan Syringe Pump from Syrris is a continuous flow chemical processing module suitable for lab-, pilot-, and production-scale applications.

August 01, 2016

The IsoBag from MilliporeSigma is used for the convenient transfer of contact and settle plates to production isolators.

August 01, 2016

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