ADC cGMP Manufacturing

ADCs consist of antibodies, payloads, and chemical linkers. The ideal ADC drug remains stable in the blood circulation, precisely reaches its therapeutic target, and ultimately releases its cytotoxic payload in the vicinity of the target (e.g., cancer cells). Each element affects the ultimate efficacy and safety of the ADC. Therefore, ADC production requires appropriate facilities that strictly adhere to cGMP standards and guidelines for the production of standard biomacromolecules. BOC Sciences has manufacturing sites in the US and UK, supporting a wide range of ADC cGMP manufacturing project needs. We can provide non-cGMP/cGMP pilot and commercial scale solutions for your ADC.

ADC cGMP Facilities

Our production base adopts the international leading design concept, the overall layout is reasonable, the partition is clear, the process flow is smooth, and it can reach the high-efficiency production technology level.

• Pilot plant covering an area of 6000 square feet, equipped with advanced and efficient key process equipment
• Dozens of large-scale reactors (500L), which can meet cGMP production batches from milligrams to grams
• Comprehensive analytical and purification equipment to support ADC purification and analytical validation
• Multiple pharmaceutical (DP) filling production lines, which can meet cGMP aseptic filling and packaging

ADC cGMP Abilities

Our R&D team has many years of ADC development experience. We have a proven track record in developing ADC projects over the years. Leveraging our strengths in chemistry, our R&D team has successfully developed and improved dozens of ADCs.

• Safe and efficient laboratory management solution to achieve seamless integration of production system and control system
• Experienced production and quality management teams ensure comprehensive refinement of technology transfer processes and risk management
• Manufacturing plants around the world are equipped with high-quality raw material supply and clean and safe production processes
• In strict accordance with FDA's GMP guidelines, a comprehensive production specification system has been established

Our ADC Production Capacity

• cGMP Antibody Conjugation: BOC Sciences' bioconjugation devices provide pilot scale to large scale therapeutic antibody production, modification and conjugation capabilities. Satisfied with a one-time scale-up, manufacturing and purification process for ADCs, our manufacturing facility supports the design, development and manufacture of ADCs throughout the product life cycle.
• cGMP Chemical Synthesis: Based on our comprehensive organic chemical synthesis platform, BOC Sciences offers customized chemical synthesis services and fine chemicals. We can provide cGMP synthesis of cytotoxic molecules targeting various signaling pathways and match highly customized linkers with different release mechanisms.
• ADC Conjugation, Purification, and Filling: After preliminary experimental validation, our ADC conjugation reactions are carried out in cGMP certified reactors. Therapeutic magazines are then removed using an advanced filter unit. The resulting ADC product was purified using single-use chromatography and then filled into sterile vials through a cGMP aseptic filling system.

BOC Sciences is also equipped with ADC characterization support services to ensure the purity and quality of the final product. Our professional impurity purification process can remove impurities such as free linkers, antibodies and ADC polymers during ADC purification. In addition, our cGMP process development services cover ADC conjugation strategies, formulations and purification protocol optimization.

ADC Manufacture

BOC Sciences' cGMP manufacturing can prepare ADCs for scale-up and commercialization. We have strict cGMP manufacturing standards, including scientific isolation controls, rigorous cleaning and sterilization processes, and FDA-compliant production and purification facilities.

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