Ben Weil, Director of Manufacturing at INmune Bio discussed the importance of early decisions in bioprocessing and manufacturing, he emphasised their knock-on implications for eventual commercialisation efforts. He advocated for considering patient and clinical needs from the outset and integrating them into the manufacturing process.
Weil stressed the significance of examining patient demographics, prevailing treatment options, and existing unmet needs. Such comprehension is vital for designing manufacturing processes capable of scaling and adapting to future requirements.
Weil stated that comprehending the mechanism of action guides various aspects of the manufacturing process, including material selection, production strategy, formulation, and administration methods. He then highlighted INmune Bio’s flexible approach: “Again, we are manufacturing led by patient and market forces means we've developed a very agile and flexible process clinic.” This optimises resource management and supports commercialisation efforts.
Furthermore, using pooled donor products can significantly increase the scalability and consistency of cell therapy products. UCL hosts one of the largest cell banks with an extensive and heterogeneous supply of HLA types which can be formulated to generate a more consistent product. This helps to manage biological variability and ensures a more reliable supply of therapeutic cells.
Weil outlined the company’s holistic outlook on sustainability, he said: “The idea is to not have sustainability as this sort of separate goal or a separate pillar in, in your in your manufacturing strategy or in your in your company values, but to really fundamentally build it into everything you do.” This includes using single-use technologies and innovating with biodegradable materials to reduce environmental impact.
Finally, Weil expressed that he adopts an all-encompassing view of bioprocessing. Considering all aspects from procurement to administration could potentially increase the likelihood of developing a successful CGT product. According to Weil, value-driven relationships with suppliers and the integration of sustainability practices should be applied to all stages of bioprocessing.