A brand new kit to accelerate clinical drug development

8 February 2023

From the initial phases of development to finished products, Gerresheimer supports laboratories in the development of their healthcare products. To reduce time-to-market and therefore bring treatments to patients faster, Gerresheimer now intends to simplify clinical development. To achieve this aim, the company has designed and developed the Clinical Trial Kit, a brand new product unveiled during the last edition of Pharmapack Europe in Paris.

Available in 6 different configurations, the kit is composed of sterile Gx RTF vials with nest & tub or EZ-fill tray, with matching caps. Ready to use, the kit allows 2R, 6R and 10R volume fills and is compatible with standard and automated filling lines. It is therefore perfectly adapted to the development of new drugs, vaccines and complex products such as biologicals. This makes it suitable for batch manufacturing regardless of the clinical trial phrase. “There are currently more than 3,000 injectable drug programs in pre-clinical and clinical phases. With our clinical trial kits and supportive services, we want to proactively support our customers by providing them with first-class primary packaging solutions,” said Jean-Edouard Rabier, Sales Development Manager and Director Project Management/Pharmaceutical Services and member of the Gx Biological Solutions Team.  

The Clinical Trial Kit complies with cGMP requirements for clinical batch production, with proven features such as container system integrity, provide a complete range of sterile containers and closures, which can be further customized by Gerresheimer’s experts.

Gerresheimer integrated services

Gerresheimer accompanies and supports its customers’ drug development from basic analysis to fill & finish service, i.e., from the early phase through to life-cycle management. For this purpose, Gerresheimer has developed a network of partners to support customers during the entire drug development journey. This includes expertise regarding regulatory implementation, development path and market approach, strategies for packaging and administration of drugs, as well as laboratory services.

Analytical laboratory services include E&L studies (components and systems), material characterization according to ISO 10993-18:2020, biocompatibility studies according to the 10993 series, toxicological risk assessment and consulting services and BEP/BER writing services.