Gerresheimer adds laboratory & regulatory services for biotech customers

Gx Biological Solutions offers enhanced services for pharmaceutical primary packaging

New laboratory and regulatory services for biotech customers. Photo - Gerresheimer

Gerresheimer adds essential laboratory and regulatory services to its broad portfolio of products, solutions, and services for biotech companies. Specialized laboratory technicians and an experienced team of further specialists offer these services in the two innovation and technology centers 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, and comprehensive regulatory support. The partnership with Gerresheimer shortens the time to market for pharmaceutical companies, minimizes risks, and saves resources.

A new generation of highly complex medications requires tailored primary packaging. For this task, Gerresheimer assembled an interdisciplinary team of industrial scientists, designers, product and process engineers, as well as product managers. The new Gx Solutions Unit develops new production technologies, processes, and components for pre-fillable syringes, vials, and carpules.

“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.

The new center 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 Drug Master File (DMF) III and the new Medical Device Regulation (MDR).

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Glass Innovation and Technology Center, Bünde (Germany)

According to the company, product support is provided by the relevant product and material experts. They take care of the correct specification and can guide regarding fill and finish questions. Chemical analyses help find the appropriate packaging system concerning material in direct contact with 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, aging tests, residual volume, fill and finish support, and orienting stability tests are just a couple of examples cutting-edge services that Gerresheimer said to offer.

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

In parallel, Gerresheimer has expanded the reach of the existing Glass Innovation and Technology Center in Vineland, the 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 reducing “time to market significantly”. At Vineland, experts and engineers who specialize in glass technology work in an environment that encourages collaboration through open offices, projects, laboratories, and meeting rooms. The environment also enables interactive collaboration with customers on-site.

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New laboratory and regulatory services for biotech customers

The Innovation Center was for Gerresheimer’s primary packaging glass business and was built in 2019, next to Vineland’s plant. In this way, the Innovation Center develops and tests new products and processes near a production site and can incorporate engineers’ operational know-how 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.

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The comprehensive range of services offered by the innovation and technology centers shortens the time required for market launch of biopharmaceuticals.

Headquartered in Düsseldorf in Germany, the manufacturer of primary glass and plastic packaging products for medication and drug delivery kept its customers supplied globally amid the coronavirus crisis. With special products made of glass and plastic, the company contributes to health and well-being. Gerresheimer is represented worldwide, and with around 10,000 employees produce where its customers and markets are and has packaging manufacturing plants in Europe, America and Asia (including India as well).

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