Drug Development

Articles

Sharing too much-or too little-information can have disastrous onsequences.

The Talk of the Lab

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material.

Implications and Opportunities of Applying QbD Principles to Analytical Measurements

is head of TechOps QA at Novartis in Basel, Switzerland, and a member of the European Federation of Pharmaceutical Industries (ADS) topic team.

is global director of global analytical R&D at Abbott Laboratories in Abbott park, IL, and a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) Analytical Technical Group (ATG).

is vice-president of Analytical Sciences at Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., PO Box 368, Ridgefield, CT 06877-0368, tel. 203.798.5701

Phil Nethercote is a director in New Product Support, Global Manufacturing Supply at GlaxoSmithKline (Ayrshire, UK).

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

Implications and Opportunities of Applying QbD Principles to Analytical Measurement

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi,  Tel. +91.9650770650, asrathore@biotechcmz.com.

References for the article published in the February issue of Pharmaceutical Technology Europe.

Quality by Design for biotechnology products: challenges and solutions &#151; References

Could flexible manufacturing change the standards for biopharmaceutical production? To find out, Equipment and Processing Report talked to James Robinson, vice-president of technical and quality operations at biotechnology company Novavax (Rockville, MD).

Biopharmaceutical Manufacturers Look for Flexibility

The authors sought to improve the productivity of protein synthesis by using a highly active cell-free extract from Escherichia coli and by optimizing buffer conditions and shaking conditions.

Large-Scale Protein Production with a Cell-Free System

Directors and staff miss the mark when it comes to following procedures.

Personnel Problems

Blame it on cafeteria gossip, outdated procedures, and major miscommunication.

Setting Things Straight

Recent advances in microreactor technology are improving the application and scale at which the technology can be applied.

Are Microreactors Practical for Large-Scale Production?

New tests solve one issue, but cheaper plastic and new stoppers cause problems.

Process and Scaling