Antibody-drug conjugates (ADCs) are at the forefront of precision cancer therapy, with more than fifteen ADCs approved globally and over 300 in development. These specialized therapies, designed to target cancer cells precisely, hold immense promise in oncology. However, with the rapid expansion of ADC manufacturing comes a unique set of challenges.
The Challenges of ADC Handling & Production
Due to the involvement of highly hazardous substances known as cytotoxic payloads, CDMOs have emerged as key players, with over 70% of ADC manufacturing outsourced to them. The core reasons behind this trend are as follows:
Complexity:
ADC manufacturing is a highly intricate process, demanding expertise in chemistry and biology. The complexity arises from the need to conjugate cytotoxic payloads to antibodies and ensure that the resulting product is potent enough to target cancer cells while minimizing off-target effects.
Coordination:
ADC production involves multiple steps, from antibody selection to payload conjugation and formulation. Coordinating these diverse processes, frequently executed by disparate teams across various geographical locations, poses time and cost strains.
Toxic Compound Handling:
Cytotoxic payloads used in ADCs are highly toxic substances. Handling and processing them requires specialized equipment and strict safety protocols to protect the workforce.
High Failure Rate:
ADC manufacturing is associated with a high failure rate, which can lead to significant financial loss. Failures can occur at various stages of the production process, from payload conjugation to clinical trials.
The Benefits of Single-Use Isolators for Cytotoxic Payload Handling
The pharmaceutical industry is increasingly adopting single-use technology in ADC production. Single-use isolators create controlled environments, reducing exposure risks and cross-contamination. They replace stainless-steel systems, eliminating timely decontamination processes, adapting to different production scales, and reducing costs.
Our recent Whitepaper explores how single-use technology revolutionizes ADC manufacturing, offering a safer, more efficient, cost-effective solution for handling high-potency active pharmaceutical ingredients (HPAPIs). Ready to delve deeper into ADCs and the benefits of single-use isolators?
soloADC™ Disposable Containment System is ILC Dover’s purpose-built, high-performance single-use containment isolator, designed solely for ADC manufacturing. Contact us to discuss your unique application today.
