Development

Norm Fong, technical transfer manager for WellSpring, is responsible for overseeing technology transfer and validation activities.

Articles

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties.
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Effective Technology Transfer and Validation Strategies with CMOs

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

Researchers Present Novel Method for Scale-Up of Stem Cell Production

Walter Matzmorr, Dr. Ing., is Principal at Tunnell Consulting, Inc.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Planning a Biologics Facility Start Up

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

PharmTech sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

How the Defend Trade Secrets Act Could Better Protect Manufacturers Who Outsource to CMOs

Mark Nachtigall, PhD, is senior scientist, Manufacturing Science and Technology, Pfizer CentreOne.

Shen Chen, PhD, is director, Global Pharmaceutical Services, Pfizer CentreOne.

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.

Practical Approaches to Tech Transfer and Scale-up of Lyophilization Processes

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Transferring the manufacturing of a drug from one scale to another or between manufacturing sites presents both technical and business challenges.

Technology Transfer Connections

Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.

Continuous Manufacturing Eases Scale Up for Solid Dosage

Partner at Jacobs Wyper Architects, 1232 Chancellor St., Philadelphia, PA, 19107, tel: 215.985.0400, www.jacobswyper.com.

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.

Flexibility vs. Right-Sizing: Determining the Right Facility Size

Barry Holtz, Principal, at Holtz Biopharma Consulting, and Klyo Collaborative, spoke with Pharmaceutical Technology about collaborative success strategies for biopharm companies.

Collaborative Success Strategies for Biopharm Companies

Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.