Manufacturing

Articles

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.

Collaboration Uses Next-Gen Sequencing for Biosafety Assessments

Meticulous system configuration can prevent machines from taking over.

Technology Fights Back

Angie Drakulich was editorial director of Pharmaceutical Technology.

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

Meeting Manufacturing Challenges Tied to Extended-Release Injectables

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.

FDA Notifies Genentech of Violations at Avastin Plant

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.

API Purification

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 Role of Bioburden in the Contamination-Control Plan

Carl Jones is a production manager (scale-up) at Protherics UK.

Aline Denton is a compliance manager at Protherics UK, Blaenwaun, Ffostrasol, Llandysul, Ceredigion, Wales, UK, SA44 5JT, tel. +44 1239 851 122.

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

Integration of Large-Scale Chromatography with Nanofiltration for an Ovine Polyclonal Product

Editors' Picks of Pharmaceutical Science & Technology Innovations

In the Spotlight November 2007

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

Simulated Moving Bed Chromatography: A Powerful Unit Operation

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

Viral Clearance