Manufacturing

Articles

Even when all is well at the facility, one must expect the worst while braving the elements.

Frozen Assets

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Experts share insights into analytical tools and techniques.

Analytical Tools for a Quality-by-Design Approach to Lyophilization

GSK Extends Deadline for Tender Offer to Acquire Human Genome Services; Sartorius Opens New Filter, Aseptic-Bag Production Facility in Puerto Rico; and More.

Week of July 2, 2012: GSK Extends Deadline for Tender Offer to Acquire Human Genome Services; Sartorius Opens New Filter, Aseptic-Bag Production Facility in Puerto Rico; and More

Experts share how to choose analytical tools and techniques when scaling up a lyophilization process.

Lyophilization: How to Meet Scale-Up Challenges Using QbD

How to avoid invisible and airborne contamination.

Avoiding Contamination Risks in Aseptic Processes

Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.

Using Closed-Vial Technology in Aseptic Filling

Amy Ritter was Scientific Editor, BioPharm International.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.

FDA Issues Final Guidance for Media Fills for Validation of Aseptic Preparations for PET Drugs

Experts discuss the best practices for developing a QbD-based lyophilization process.

Freeze-Drying: Is Technology Advancing Fast Enough?

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

There are no two completely identical freeze dryer units in operation anywhere.

The Freeze Drying Challenge

Lyophilisation is often necessary for pharmaceutical products to improve stability or shelf-life. However, the process can present difficulties, particularly when scaling up from the laboratory to commercial production. We bring experts together to discuss best practices for developing a lyophilisation process, including quality by design (QbD) and design space.

Manufacturing, Parenterals and Injectables