On October 24-25, 2020, the Third Antibody Drug Industry Development Conference was held in Shanghai. Industry leaders from the antibody drug R&D industry and scientific research institutes gathered in Shanghai for this popular conference. Dr. Nick Kotlarski, COO of Bioworkshops, was also invited to discuss GMP compliance for monoclonal antibody clinical drug products.

In the early development and preclinical stages, controlled handling of materials, sound test methods, and documented records of processes are key factors to ensure success. Moving from research into clinical development, cGMP must be followed, but it is difficult to carry out production activities in full compliance with the controls of a commercial product. Many healthcare regulators have published guidelines or regulations for investigational drug products. The production and testing of clinical materials should not only comply with these regulatory requirements, but also be developed with the longer-term objectives of commercial supply in mind. Dr. Kotlarski shared his experience in development and clinical production of biological drugs and a summary of useful industry guidance to achieve the reasonable balance between sound scientific practice and commercial compliance that is accepted by regulators.

Dr. Kotlarski introduced how the production and quality control of clinical biological drugs must conform to the laws and regulations of various countries and optionally consider industry guidelines in the specifications and procedures of actual operation of the company. The United States, Europe, and China have all issued formal Good Manufacturing Practices or draft guidance for clinical medicinal products. The background of all three national/regional authorities is commercial cGMP. While Chinese and European regulations are similar, U.S. regulations are more targeted and emphasize data integrity. These regulations are complementary to each other and provide useful reference for the production of early-stage clinical materials.

Dr. Kotlarski emphasized a PDA Technical Report as a valuable industry guideline for phase-appropriate GMP compliance. Operation requirements such as the controls of raw data in different stages, the depth of equipment validation, and the requirements of method validation, are listed by the phases of R&D, toxicology, and clinical phases I through III.

While introducing the regulatory requirements and industry guidelines, Dr. Kotlarski also introduced the current practices of Bioworkshops. From the very beginning of the company, Bioworkshops designed a quality system to control the safety and effectiveness of products based on risk assessment and phase-appropriate controls. Over 700 SOPs and “3Q validation” for GMP facility and critical utilities have been completed, which deliberately exceed minimum regulatory requirements for early-stage clinical materials to ensure the quality and safety of client products. While ensuring quality and regulatory compliance, Bioworkshops shortens drug development cycles and helps customers quickly move their projects into clinical or approval stage.