Articles on analytical & statistical methods, process analytical technology - BioPharm International

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Quality
Essential information about quality assurance and quality control, including analytical methods, analytical method development, statistical methods, and process analytical technology (PAT).

Single-Use Bioreactors for the Rapid Productionof Preclinical and Clinical Biopharmaceuticals

October 1, 2014

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

Continuous Improvement in Biopharma Manufacturing

October 1, 2014

Unexpected problems can become opportunities to share knowledge and improve processes.

Application of Quality by Design to Viral Safety

October 1, 2014

A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.

Challenges in Biologic Drug and Vaccine Delivery

October 1, 2014

Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.

Continued Process Verification for Biopharma Manufacturing

October 1, 2014

The authors discuss complications of implementing continued process verification and provide recommended approaches.

Optimizing Human Performance: A Road Worth Traveling, Part 3

September 3, 2014

This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.

Quality Agreements for Contract Manufacturers

September 1, 2014

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

Healthcare Reform in China

September 1, 2014

Chinese healthcare reforms may be a double-edged sword for foreign companies.

Assessing a Risk Management Program

September 1, 2014

Program review can help quality risk management live up to the promise of ICH Q9.

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