Swiss based Cerbios-Pharma SA, specialized in the development and manufacturing of chemical and biotechnological APIs, is pleased to announce the completion of its new manufacturing building dedicated to Cytotoxic molecules. The fitting and installation of the equipment that was started in Q2 2022 in the freshly constructed structure, is now completed and the new facility will become operative in Q2 2023 after Swissmedic approval. Such investment has the purpose of implementing up to date technologies and to increase the number of manufacturing lines, designed on the basis of modern concepts that ensure to fulfil the latest safety standards by keeping the maximum flexibility and resulting in an additional tool for HPAPIs service portfolio.
Cerbios is active in the HPAPI arena since 1993, handling Drug Substances with containment level equivalent to category 4 SafeBridge® (OEL<10 ng/m3). With dedicated R&D and scale up facilities and cGMP manufacturing lines ranging from grams up to 30+ Kg batch size Cerbios manufactures both cytotoxic and non-cytotoxic HPAPIs.
The new unit will add to Cerbios capabilities two complete lines for HPAPI manufacturing, primarily dedicated to ADC linker-payloads and cytotoxic APIs with exposure limit down to OEL<10 ng/m3 (equivalent to category 4 SafeBridge®)and will host productions ranging from mg to low kg scale per batch. State-of-the-art plant equipment include also low- and high-pressure chromatography, lyophilization and nanofiltration that are required for the manufacture of complex molecules. Along with the conjugation suites for Antibody Drug Conjugates, these new production lines completes Cerbios offer and makes it an ideal partner for HPAPIs and ADCs, with the possibility to cover all the phases from the production of non cGMP batches needed for preclinical tests, through clinical to commercial supply. For the future, Cerbios has expanded the surface available for a further capacity increase: the target is in fact to double the ADC capacity investing in a new hub with the aim to expand the company commitment to provide best-in-class bioconjugation services for the worldwide partners.
