Gerresheimer has presented its new Clinical Trial Kit at Pharmapack in Paris. The kit consists of sterile Gx RTF vials in a nest and tub or tray with matching closures and is tailored to requirements to support the development of new drugs, vaccines, and biologics in early phases. The Clinical Trial Kit is suitable for small-batch manufacturing from first-line trials to validation and clinical batches. It can be ordered in six different configurations of Gx RTF glass vials. Other kits, including Gx Elite and Gx RTF COP vials, will follow soon.
Gerresheimer is a global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems.
“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 the 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 containers and containment solutions, specially selected for high-value drugs and/or the 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 a 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 expert 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.