View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Gerresheimer Group
21 September 2020

New Laboratory and Regulatory Services for Biotech Clients

Gerresheimer adds essential laboratory and regulatory services to its broad portfolio of products, solutions and services for biotech companies. Specialised laboratory technicians and an experienced team of further specialists offer these services in the two innovation and technology centres in Bünde (Germany) and Vineland (New Jersey/USA). Gx Biological Solutions offers full service for biotech companies regarding product development of primary packaging and drug delivery solutions, material and functional testing as well as comprehensive regulatory support. The partnership with Gerresheimer shortens the time to market for pharmaceutical companies, minimises risks and saves resources.

“Our Glass Innovation and Technology Centers, with their new laboratory and regulatory services, take a lot of the work off our customers on the long road to regulatory approval,” says Stefan Verheyden, Global Vice President of the Gx Biological Solutions Team.

Glass Innovation and Technology Center, Bünde (Germany)

The new centre is located at the production site for glass syringes, injection vials and cartridges in Bünde. The range of services includes laboratory and regulatory services by regulatory experts for DMF III (Drug Master File) and the new MDR (Medical Device Regulation). Product support is provided by the relevant product and material experts. They take care of the correct specification and can guide regarding fill & finish questions. Chemical analyses help in finding the appropriate packaging system with regard to material in direct contact to the drug formulation, such as glass, tungsten, adhesives, silicone oil or polymers. Customer-specific developments and design proposals are also developed and adapted to intelligent solutions as required. Throughout the whole value chain of drug development, subsequent testing and analyses can be conducted. Material and particle analysis, extractables and leachables testing, container closure integrity investigations, drug container interaction and ageing tests, residual volume, fill & finish support and orienting stability tests are just a couple of examples of the cutting edge services that Gerresheimer will offer.

Additionally, a sample stock will hold many frequently used possible container formats for biopharmaceutical development enabling our customers to rapidly respond to any urgent market requirements they might face. The Gx innovative portfolio includes strengthened glass vials (both in non-sterile and ready-to-fill format) silicone-free syringes, safety devices, also in already assembled, sterilised and nested format (Gx RTF), and other intelligent primary packaging solutions.

Glass Innovation and Technology Center, Vineland (NJ/USA)

In parallel Gerresheimer has expanded the reach of the existing Glass Innovation and Technology Center in Vineland (NJ/USA) with a comparable extended service offering as specified for the Bünde site. Next to the existing material science capabilities, an extensive offering of functional testing will be added. The bundling of development capacities with dedicated lab and regulatory services for primary packaging such as injection vials and cartridges has clear advantages when it comes to significantly reduce “time to market”. At Vineland, experts and engineers who specialise in glass technology work in an environment that encourages collaboration through open offices, project, laboratory and meeting rooms. The environment also enables interactive collaboration with customers on-site. The Innovation Center was the first of its kind for Gerresheimer’s primary packaging glass business and was built in 2019 next to the plant in Vineland. In this way, the Innovation Center develops and tests new products and processes in close proximity to a production site and can incorporate the operational know-how of engineers from this plant. In addition, Gerresheimer’s other American production sites can also use the service. It comprises a detailed analysis of the primary packaging material; for example, the material, surfaces and functions of injection vials are tested and chemical analyses are carried out. Gerresheimer also accompanies and supports its customers with regulatory support, official documentation and registration.

For more information, please fill out the enquiry form attached to this page.

Gerresheimer is a leading global partner to the pharma and healthcare industry. With specialty glass and plastic products, the Company contributes to health and well-being....
Gerresheimer is one of the leading specialists for the production of high-quality glass and plastic products for the international pharmaceutical and healthcare industry.
During the Covid-19 pandemic, Gerresheimer is focusing on aspects including business continuity, customer demand, and supply chain. In 2019, we paved the way for profitable...
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Pharmaceutical Technology