Viral Clearance

The new column features Natrix’s signature macroporous hydrogel.

Medicago's new production facility will make plant-based vaccines and therapeutics.

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing (NGS) based biosafety assessments to detect and identify viral contaminants within biologic compounds.

Meticulous system configuration can prevent machines from taking over.

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.

Editors' Picks of Pharmaceutical Science & Technology Innovations

High performance liquid chromatography has become an efficient technique at the production scale, and simulated moving bed chromatography provides several benefits during processing.

Special considerations and cautions must be adhered to when designing virus safety studies and developing appropriate virus contamination control programs.