Manufacturing

Articles

How soon could the pharmaceutical industry see a widespread adoption of emerging technologies that are poised to shape its future?

The Technological Evolution Driving Pharma’s Future

Agnes Shanley is senior editor of Pharmaceutical Technology.

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

Getting Biopharmaceutical Tech Transfer Right the First Time

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

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

The author reviews some of the key considerations when selecting a vendor and crucial parameters that must be defined in the tech-transfer process to ensure the greatest chance of success.

Planning for Successful Technology Transfer

Outsourcing Pharmaceutical Manufacturing: Keys to Succesful Technology Transfers

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

Best Practices for Product Transfer

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

Andrew Harrison is chief regulatory affairs officer and general counsel with Regulatory Compliance Associates.

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.