Manufacturing - BioPharm International

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Manufacturing
Equipment, processing, and procedures for biopharmaceutical manufacturing.

Predicting Lyophilization Performance

March 1, 2014

Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.

Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum

December 1, 2013

Criticality is used as a risk-based tool to drive control strategies.

Implementing QbD in Sterile Manufacturing

December 1, 2013

Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.

Opioid Regulation Challenges FDA and Manufacturers

December 1, 2013

New policies and products seek to maintain access to pain medicines while curbing rampant abuse.

Evolution of the Monoclonal Antibody Purification Platform

November 1, 2013

The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.

Disposable Applications in Demand by Biopharma

November 1, 2013

Data from BioPlan Associates' 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

Congress Revises Rules for Drug Compounding and Supply-Chain Security

November 1, 2013

Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.

FDA Seeks Metrics to Define Drug Quality

October 1, 2013

Manufacturing standards are considered key to preventing drug recalls and shortages.

Angiopoietins: Novel Targets for Anti-angiogenesis Therapy

October 1, 2013

The authors review the angiopoietin pathway as an alternative for safer and more efficacious anti-angiogenic therapeutics.

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