Drug Development

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

Articles

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.

Qualifying Personnel to Visually Inspect Cleaned Equipment Part II: Small vs. Large Group Training

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

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

A US government report on advanced manufacturing promotes continuous manufacturing of pharmaceuticals, which has had recent commercial success but faces challenges for widespread adoption.

Next Steps for Investment in Continuous Manufacturing Research

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

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

FDA Releases Guidance on Immunogenicity Testing of Therapeutic Proteins

FDA explains the rewards that may be associated with switching from batch to continuous manufacturing.

FDA Blog Encourages Use of Continuous Manufacturing

FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain’s facility in Puerto Rico.

FDA Approves Tablet Production on Janssen Continuous Manufacturing Line

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

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.

Process and Scaling