Development

Mark Witcher is senior consultant at Brevitas Consulting, witchermf@aol.com

Articles

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures. 

Improving Prospective Product Development Methods Derived from Management-Based Regulatory Guidelines

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

Can Bioprocessing Achieve Digital Transformation?

Agnes Shanley is senior editor of Pharmaceutical Technology.

Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.

Good Laboratory Practices: Getting on the Same Page

Kieran O’Connor is Analytical Science and Technology senior chemist at SK biotek, Ireland, kieran.oconnor@sk.com. (formerly Bristol Myers Squibb)

John Wasylyk is senior principal scientist at Bristol-Myers Squibb, USA; john.wasylyk@bms.com

Bob Wethman is senior research scientist II at Bristol-Myers Squibb, USA

Ming Huang is senior research investigator I at Bristol-Myers Squibb, USA

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing. 

Spectroscopy Facilitates Lean Analysis

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.

Proper Process Development and Drug Shortages

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.

Bio/Pharma Needs Ideas and Incentives to Advance Manufacturing

Claire Hill is solutions support manager at IDBS.

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming. 

Continued Process Verification and the Drive to Digitize the Process Validation Lifecycle

Naheed Sayeed-Desta is manager of process validation at Apotex, Inc.

Marzena Ingram is senior manager, quality and compliance at Eurofins CDMO. She led and hosted several cGMP audits, and has diverse quality assurance and technical operations experience. 

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.

Lifecycle-Based Process Validation Emphasizes the Need for Continued Process Verification

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?

Lies That Environmental Monitoring Systems Tell

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.