On 2-3 November 2020 the 2^nd Global Biomedicine CDMO Development Forum was successfully held in Suzhou. Experts in antibody drugs, cell and gene therapies, preventive and therapeutic vaccines, stem-cell regenerative medicines, and other biomedical fields gathered to discuss and exchange hot topics impacting the whole industry sector.

As a special guest speaker, Dr. Nick Kotlarski was invited to present on the topic of GMP for clinical monoclonal antibody products. Dr. Kotlarski outlined the applicable regulatory requirements for antibody production in clinical development, including the core content of Chinese, EU, and US-FDA GMPs. In early-phase development, quality risk management is essential to meet the requirements of GMP to produce drug substance that is safe. Dr. Kotlarski also introduced the international GMP guidelines related to commercial antibody products and highlighted key issues which need to particular attention in practice, including phase-appropriate control measures of GMP requirements across the stages of R& D to market such as validation of analytical test methods and assurance of data integrity.

To conclude, Dr. Kotlarski introduced Bioworkshops’ advanced GMP plant and quality system, to share practical application of the global regulations for IND products with the audience. Bioworkshops has designed a quality system to control the safety and effectiveness of products based on quality risk management, adopting harmonized industry standards applicable to both clinical and commercial products, completing more than 700 SOPs, and hundreds of validation protocols for the GMP plant and equipment. This practice exceeds the minimum regulatory requirements for early-stage clinical products, but is expected of a CDMO. Investing in higher standards of control helps to shorten the drug R& D cycle and ensure the quality, safety, and regulatory compliance of clients’ products entrusted to Bioworkshops. Helping clients go faster with good quality.

At the opening ceremony of the conference, Bioworkshops was awarded a “Future star of China’s biomedical CDMO enterprise in 2020”in the Xing Yao List. The Xing Yao List recognizes excellence in biological innovative drugs and service providers. The main evaluation criteria were potential investment value, R&D and innovation ability, clinical progress of new drugs ,and industry reputation.

Bioworkshops is honored to be recognized by the industry and to receive this award. As a rapidly growing CDMO, Bioworkshops team are eager to share their decades of accumulated experience in Chemistry, Manufacturing, and Controls (CMC) of biological products to benefit our clients.