Process Development for Antibody Drug Conjugates

Antibody-drug conjugates (ADCs) are highly targeted biopharmaceutical drugs that combine monoclonal antibodies specific to surface antigens present on particular tumor cells with highly potent anti-cancer agents linked via a chemical linker. Antibody-drug conjugates represent an innovative therapeutic application that combines the unique, high specificity, properties, and anti-tumor activity of monoclonal antibodies (mAbs) that are tumor-specific but not sufficiently cytotoxic, with the potent cell-killing activity of highly cytotoxic small molecule drugs that are unsuitable for systemic administration alone. ADCs are currently being developed for the treatment of a variety of cancers including breast cancer, lymphoma, and leukemia.

Fig. 1 Structure of antibody-drug conjugates.

With advanced technology and experienced staff, Creative Bioarray provides comprehensive cell support services in the process development for antibody-drug conjugates to help our customers worldwide. We delivered rapid and accurate results to assist customers to accelerate their research.

Our Processing of Antibody Drug Conjugates

• From cell line to antibody production services. Starting with an initial cell line, a scalable process template is developed to produce cGMP batches of the antibodies.
• Finding the missing link for pay supply. A highly active payload and drug linker are matched with the antibodies for eventual conjugation into an antibody drug. Advanced payload intermediates for the most common classes of payloads can help to reduce development timelines.
• Bioprocess development of ADC construction, including synthesis of re-bridging linker, linker-MMAE payload, and ADC production. The developed components of the cell line, antibody, payload, and linker come together during conjugation and/or bioconjugation.
• ADC final purification and filling. The therapeutic impurities are removed utilizing advanced filtering devices. The ADC product is purified using single-use chromatography systems and finished by filling into aseptic vials.

The Role of Cell Banks in Antibody Manufacturing

• The antibodies used in ADC processing mostly are produced in mammalian cell expression systems using Chinese hamster ovary (CHO) or murine lymphoid cell lines (e.g., NS0, Sp2/0). The availability of a suitable expression system and the importance of post-translational modifications of the recombinant antibodies may also affect the choice of a cell line for use.
• We provide cGMP-compliant CHO, NS0, Sp2/0, and other cell banking services as strong support for antibody manufacturing in ADC processing, which aims to provide a reliable stock of cells that can be utilized in a wide variety of research settings.

As a professional services provider in the field of cell science, Creative Bioarray provides high-quality cell support services in the process of development for antibody-drug conjugates to our customers worldwide. We provide our clients with direct access to our experts and prompt responses to their questions. If you are interested in our services or have any questions, please feel free to contact us or make an online inquiry.