Charlie Johnson, CEO of ADC Bio, explains his company’s approach to process innovation for antibody drug conjugates, and the need for drug developers to create more efficient manufacturing processes.
The antibody drug conjugate (ADC) development industry must address and overcome the current industry challenge of how to create much needed and more efficient manufacturing processes – innovation which is not at present being completed by pharma. At present, a number of the larger CDMOs are focused solely on commercial scale ADC production and lack both the bandwidth and the motivation to design innovative manufacturing methods. Consequently, I predict that this problem will be addressed by the more specialist ADC focused service providers designing the next crucial phase of innovation at the clinical development stage – achieving the goal of further optimizing and streamlining ADC production processes.
Our sector is still some way off from having a fully optimized set of processes for the ADC supply chain. As a product class, antibody drug conjugates are still in their infancy. As a consequence, there are a number of process improvements that can be made to the production of cytotoxics, including the linkers that bind them to antibodies, and other important elements across the supply chain. In my view, to speed up the next generation of processes, innovators need to start considering how to improve process R&D at the early inception of a product. In particular, biotech customers may well hold the key to increased adoption – given that larger pharma companies might be too risk adverse – embracing innovation to deliver more efficient systems for producing their drug candidates in clinical development.
Another of the drivers stimulating the need for more flexible and efficient manufacturing is the diversification of therapeutic indications for ADCs, beyond what has historically been an oncology-dominated focus. Therapeutic indications for non-cancer treatment, for example antimicrobial and anti-inflammatory targets, can require increased product volumes and manufacturing capacity. CDMOs must also have the right infrastructure and procedures in place to manufacture the compounds seamlessly across different therapeutic classes, whilst satisfying stringent regulatory requirements. The greater the ADC production levels, the higher the need for new efficiencies that reduce the overall manufacturing cost in early stage development – previously only limited volumes of candidates were needed.
One approach to improve supply chain efficiency is to have one CDMO undertake more parts of the supply chain – for example, bioconjugation of antibodies and cytotoxics and fill finish services, or antibody production and bioconjugation. Both concepts have huge potential to deliver cost savings and reduced production time. Indeed, In the case of one supplier for both producing the antibodies and carrying out bioconjugation, it has been estimated that a reduction of up to three months in production would be achieved.
