Gerresheimer adds laboratory & regulatory services for biotech customers
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 ii innovation and technology centers in Bünde, Germany, and Vineland, New Jersey, USA. Gx Biological Solutions offers full service for biotech companies regarding product evolution of master 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, production and procedure engineers, as well as product managers. The new Gx Solutions Unit of measurement 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 route to regulatory approval," says Stefan Verheyden, global vice president of the Gx Biological Solutions Squad.
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) Three and the new Medical Device Regulation (MDR).
According to the company, product support is provided by the relevant product and textile experts. They take care of the correct specification and can guide regarding fill and finish questions. Chemical analyses help detect the advisable packaging organization concerning material in direct contact with the drug formulation, such every bit glass, tungsten, adhesives, silicone oil, or polymers. Customer-specific developments and design proposals are also developed and adapted to intelligent solutions equally required. Throughout the whole value chain of drug evolution, subsequent testing and analyses can be conducted. Material and particle assay, extractables and leachables testing, container closure integrity investigations, drug container interaction, crumbling tests, residual volume, fill and finish support, and orienting stability tests are just a couple of examples cut-edge services that Gerresheimer said to offer.
Additionally, Gerresheimer said, a sample stock volition hold many frequently used possible container formats for biopharmaceutical development, enabling our customers to respond to any urgent market place requirements they might face up rapidly. The Gx innovative portfolio includes strengthened glass vials (both in not-sterile and gear up-to-fill format) silicone-gratis syringes, safe devices, and already assembled, sterilized, and nested format (Gx RTF), and other intelligent main packaging solutions.
In parallel, Gerresheimer has expanded the reach of the existing Glass Innovation and Technology Middle in Vineland, the United states of america, with a comparable extended service offer as specified for the Bünde site. Next to the existing textile science capabilities, an extensive offering of functional testing will be added. The bundling of evolution capacities with dedicated lab and regulatory services for master packaging such as injection vials and cartridges has clear advantages when it comes to reducing "fourth dimension to market significantly". At Vineland, experts and engineers who specialize in glass applied science work in an environment that encourages collaboration through open up offices, projects, laboratories, and coming together rooms. The surround likewise enables interactive collaboration with customers on-site.
The Innovation Middle was for Gerresheimer'southward master packaging drinking glass business and was built in 2019, adjacent to Vineland's constitute. In this mode, the Innovation Center develops and tests new products and processes nearly a product site and can contain engineers' operational know-how from this found. In addition, Gerresheimer's other American production sites can also use the service. Information technology comprises a detailed analysis of the primary packaging textile; for example, the material, surfaces, and functions of injection vials are tested, and chemic analyses are carried out. Gerresheimer also accompanies and supports its customers with regulatory support, official documentation, and registration.
Headquartered in Düsseldorf in Deutschland, 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 wellness 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 besides).
Source: https://packagingsouthasia.com/application/gerresheimer-adds-laboratory/
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