Blogs

Contamination control has come to dominate conversations around implementation of the revised European Union’s Good Manufacturing Practice Annex 1 (EU GMP Annex 1). 

Development in gene therapies is continually increasing – presently over 1,400 companies are involved, with over 2,200 clinical trials underway. It is essential to find an appropriate containment system to protect the time and monetary investments required to create these treatments.

West is pleased to welcome guest blogger and valued corporate partner The American Red Cross

Annex 1 of the European Union’s Good Manufacturing Practice guidelines (EU GMP Annex 1) has loomed large over the manufacture of parenteral products since it was first introduced in August 2022.

Among the many sessions at the recent Parenteral Drug Association Week (formerly PDA Annual Meeting) in Palm Springs, CA, several focused on advanced therapy medicinal products (e.g., cell therapies, gene therapies), biosimilars, and disruptive therapies (e.g., live biotherapeutic products). With the growth of these therapies, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50^oC to ≤ -130^oC.

The apprenticeship as an industrial mechanic at our Germany site offers basic experience in important areas. From day one, the aim is to learn the basics that will later be crucial for working with machines and in industry. An important part at the beginning of the training is the basic course – a kind of "training at the workbench" that helps the trainees to familiarize themselves with the basic skills.