Manufacturing

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

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

Articles

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.

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

Mahmoud Hamada is business development manager of Inspection Technology for Bosch Packaging Technology, tel. +49.7951.402.1620, Mahmoud.Hamada@de.bosch.com.

Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.

Testing the Integrity of Lyophilized Product Containers

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

Headspace Moisture Analysis for Determination of Residual Moisture Content in Lyophilized Pharmaceutical Products

The expansion will enable relocation of its North American headquarters from Grayslake, Illinois.

Xellia Pharmaceuticals Expands Raleigh Site as New North American Headquarters

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

With drug development trends shifting towards personalized medicines, new technologies are needed for the manufacture of these highly sensitive drug products.

With Processes, It’s All About Optimization

Lyophilization Services of New England announces inspection approvals that will allow its Bedford, NH facility to begin manufacturing commercial drugs for US distribution.

CMO Announces Distribution of Commercial Drugs from New England Facility

Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.

Symbiosis Launches Bulk Lyophilization Service

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

Controlled Nucleation for a Monoclonal Antibody Formulation—A Case Study

The VERISEQ nucleation technology offers a commercially viable technique for cryogenically generating a uniform dispersion of microscopic ice crystals (or ice-fog).

New Developments in Controlled Nucleation: VERISEQ Nucleation Technology

Katriona Scoffin is a science writer with Biopharma Technology Ltd., Winchester, England

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.

Manufacturing, Lyophilization