Blogs

As drug manufacturers aim for higher safety standards and enhanced patient care, controlling the drug product at the point-of-use in a hospital or clinical environment remains a significant challenge. The method of vial access often varies, increasing the risk of adverse patient outcomes, such as stopper cores or fragments entering the drug product. If injected, these fragments can lead to cardiovascular events and other complications. Several factors contribute to stopper coring and fragmentation in the field, primarily influenced by the technique of the practitioner and the properties of the elastomeric closure.

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.