Monoclonal antibodies (mAbs) are large glycoproteins that can very specifically bind to target antigens and are widely used as therapeutic products in oncology and autoimmune treatments.
At Synthon Biopharmaceuticals, mAbs are produced using mammalian cell culture systems. Activities vary from vector design and cell line generation to upstream, downstream, formulation and final fill process development. Analytical development also takes place.
After process and analytical methods have been developed within the R&D laboratories, they are transferred to our cGMP Operations and QC organizations for manufacturing in a manner suitable for clinical supplies and early launches. The construction of our GMP facility for manufacturing monoclonal antibodies was finalized in December 2014. During 2015, the qualifications of all utilities and equipment were successfully completed, including all equipment required at a 2,000L scale.
We are able to express proteins in a range of mammalian cell lines, both for research and cGMP production purposes. Cell line development, medium optimization and cell culture process development are all supported by sophisticated and fully equipped culture laboratories.
For purification of the different therapeutic bio-molecules and development of formulations for the final product, state-of-the-art technologies (e.g. high-throughput screening) are used to develop efficient and economically feasible processes.
Ultramodern GMP plant for the production of therapeutic monoclonal antibodies, a flexible multi-product plant with a manufacturing capability comprising dual 2,000L bioreactors based on single-use technologies.
Different technological aspects
Bioanalytical assays play a vital role establishing the quality, purity and safety of our biopharmaceutical products. A broad range of analytical methods is provided in four different technological aspects, encompassing binding, potency, purity and structure determination. Besides its expertise in essential release testing of batches of our biopharmaceutical products, our analytics group also has outstanding capabilities for determining the structure/conformation using state-of-the-art equipment.