When it comes to the manufacturing of drugs, particularly highly sensitive biologics, a high-level of expertise is required. Typically, small and medium-sized pharma and biotech companies lack the knowledge and know-how necessary to cover all the processes independently prior to completion of the entire final product.
That is why they are dependent on strong partners such as an experienced CDMO for the filling and packaging of the developed substance. From development support to commercial filling and secondary packaging, the accomplished CDMO offers everything at a single source.
Pharma companies that outsource their processes to just a few service providers can save product and process knowledge through out the entire value chain. With the help of know-how gained from successfully completed development projects, clinical manufacturing processes can also be transferred more easily to commercial production, there by shortening process planning, avoiding unnecessary redundancies and reducing both risk and costs.
Planning: The sooner the better
The establishment of a partnership with an experienced CDMO early in the process can often make the difference. The sooner and ore carefully the entire production process is planned, the more value can be maximized from the overall drug package. In addition to comprehensive support during development -- particularly critical for complex active ingredients, this step also includes fill and finish services. The use of high-performance production facilities for clinical filling leads to high-quality and reliable results, even with complex and sensitive substances.
Comprehensive support throughout all phases of drug development and manufacturing
A qualified one-stop shop provides support not only in the early clinical phases, but also later in the process, for example, when launching the product and commercializing the production process. Such shops offer all services from one single source. Pharma and biotech companies, in particular, benefit from a comprehensive range of products and services that are optimally tailored to meet the needs of their substances.
In addition to ongoing quality control by means of pharmaceutical analyses in modern laboratory facilities, support for regulatory inspections is also included. After all, experienced CDMOs have long-term relationships and extensive expertise in working with authorities around the world and, as such, are always up to date with the latest regulatory requirements. In addition, they support the preparation and compilation of necessary documentation for clinical trials as well as for market approval.
Innovative packaging development completes the full service package
All phases of product development are accompanied by packaging material development. Competitive advantages can be achieved with vial alternatives such as prefilled syringes. It is important to always have the final product in mind, for example, when the time comes for finding the most suitable secondary packaging such as blistering or cartooning. The use of special injection systems like dual-chamber products, pens, auto-injectors or safety devices make it possible to differentiate one self from the competition, especially in the area of life cycle management.
With a strong full-service provider by their side, pharmaceutical and biotech companies can focus on further product development, while an experienced CDMO like Vetter manages their processes and infrastructure.
Dr. David Brett, Team Leader, Productand Service Management, Vetter Pharma International GmbH
Dr. David Brett studied Biological sciences at the University of East Anglia in the UK. He earned an MBA at the University of Bayreuth, Germany, and a PhD in Biochemistry at Imperial College in London.
After postdoctoral positions at the Institute of cancer research, he trained at Bioinformatics with a focus on pharmaceutical drug target screening. In the Siemens Healthcare strategy and innovation department, he worked on a number of topics including protein target molecules for cancer & diabetes, e-health, personalized medicine, and molecular imaging.
David joined Vetter in 2010 as product and service manager with a focus on innovation in injectable drug-delivery systems, clinical development and commercial manufacturing. He became Team leader of Product and Service Management in 2015, and is responsible for the development of Vetter’s service offering to optimally fit customer requirements.
About vetter pharma
Headquartered in Ravensburg, Germany, Vetter is a global leading contract development and manufacturing organization (CDMO) with production facilities in Germany and the United States. The company has long-term experience offering services ranging from early development support including clinical manufacturing, to commercial supply and various packaging solutions for vials, syringes and cartridges.
Vetter’s customers range from small and midsize to the world’s top 20 pharmaceutical and biotech companies. As a leading solution provider, the CDMO recognizes its responsibility in supporting the needs of its customers in developing devices that contribute to increased patient safety, convenience, and enhanced compliance. Learn more about Vetter at www.vetter-pharma.com