“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.

Simplifying the clinical development of drugs
The Gerresheimer Clinical Trial Kit simplifies the clinical development of drugs by offering pre-tested and validated solutions that are readily usable for small batch sizes to replace commercial production. The major advantage of this concept is that companies can benefit from the exact same performance of the containers during commercialization as during research and development. This helps to shorten time to market and bring life-saving drugs to patients faster.

Sterile Gx RTF Vials and a selected range of stoppers and closure options
The kit provides a complete set of primary packaging container and containment solutions, especially selected for high value drugs and/or most complex and demanding drugs. The Clinical Trial Kit complies with GMP requirements for the production of clinical batches. It is currently offered in six different configurations with nest and tub or tray for filling volumes 2R RTF, 6R RTF and 10R RTF. Customers may receive a tailored kit made from a range of stopper and closure options selected using expertise advice. Each kit offers tried-and-tested product features, such as the integrity of the container system.

Additional 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.

Formulation, fill & finish
Together with selected partners, Gerresheimer supports its customers throughout their journey from the early pre-clinical phase to the start of clinical and commercial batch supplies. Regardless of whether they are CROs, CMOs or CDMOs, Gerresheimer knows the right partners for a wide range of drugs including vaccines, mAbs, mRNA-based drugs and ATMPs.