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Regulatory expertise
The growing promise of biopharmaceuticals opens significant commercial opportunities for drug developers. At the same time, it also increases the pressure to rapidly bring candidates to the clinic and therapies to market.
To accelerate your path to your next milestone, we offer programs for the entire lifecycle of any molecule type, from preclinical to commercial stages, from drug substance to drug product.
Depending on the needs of your molecule and your priorities in terms of timelines, yield optimization and risk, we can leverage our global network and capabilities to offer bespoke and tailored programs:
DNA to Clinic Programs
Clinic to Market Programs
The variety of our offerings provides the flexibility of a complete program or the option to drop in at a later stage depending where you are in your journey.
As you move your molecule from the research phase into clinical and commercial manufacturing, key challenges to be addressed include the need to maintain high productivity, product quality and reproducibility. A successful outcome will often require significant technical expertise and advanced development and manufacturing technologies.
In our extensive services portfolio, we use advanced technologies and decades of know-how to quickly and efficiently develop and manufacture biotherapeutics such as monoclonal antibodies, bispecific antibodies, Fabs, fusion proteins, scaffolds and other recombinant proteins.
Get access to a wide range of contract development and manufacturing services from lead candidate selection and optimization cell line, process, analytical and formulation development, process optimization as well as drug substance and drug product manufacture from small to large scale.
We develop and produce mammalian-derived biopharmaceuticals in highly advanced cGMP multi-product facilities, in a global network across three continents: America, Europe and Asia.
We work with clients of all sizes, from small biotech to multi-national pharmaceutical companies, tailoring our services to meet your specific needs. We are committed to your success to help you meet your product and company milestones.
We recognize that different supply strategies, processes and product demands will require different manufacturing scales and technologies. For this reason, we provide flexibility and support a wide range of capacities, from 1 to 20kL, as well as single-use and stainless steel technologies, through our global and expanding network. Our experts, who live and breathe mammalian, will guide you through selecting the optimum scale and format for the manufacturing of your product.