The future of cancer therapy

Complex ADC processing requirements

The production of ADCs is demanding and requires strict controls at every step of the process to ensure a safe and effective end product. Core aspects include:

• Component choice: ADCs consist of a monoclonal antibody, a cytotoxic drug, and a linker that connects the two. The selection and quality of these components determine the stability and effectiveness of the product.
• Production and conjugation: The conjugation process – the bonding of the antibody to the cytotoxic agent – requires precise control and purity. Exact dosing is essential to achieve the right drug-antibody ratio.
• Quality control: To ensure the highest standards, ADCs are rigorously tested for stability, purity, and potency. This includes comprehensive in vitro and in vivo tests to ensure safety and effectiveness over the entire shelf life.
• Regulatory compliance: ADCs are subject to strict regulatory requirements, including Good Manufacturing Practices (GMP). Detailed documentation and tests must be submitted to the supervisory authorities in order to obtain market approval.
• Specialized facilities: The production of ADCs requires highly specialized production facilities that are designed for both aseptic processing and the containment of cytotoxic substances. These measures protect employees and prevent cross-contamination.
• Packaging and storage: ADCs must be packaged under sterile conditions and stored at special temperatures to preserve their stability and effectiveness. Seamless monitoring of the cold chain is essential here.
• Environmental and occupational safety: The safe disposal of cytotoxic waste and the implementation of strict safety protocols are critical to protecting both the environment and employees.

For pharmaceutical companies, processing and filling highly potent drugs is full of challenges: Small volumes and quantities demand a great containment effort. Optima provides you with all-round support for these tasks, thanks to the holistic process and complete turnkey systems.

Our expert Ramin Ramezani will discuss the trends in the ADC market in another blog article.

Trends in the ADC market