BioPharm International - February 2020

BioPharm-Outsourcing eBook

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www.biopharminternational.com February 2020 BioPharm International eBook 15 nal antibodies (mAbs) and recom- binant proteins were industrialized. While cell and gene therapy is much more complex, with autologous, viral, allogenic or in-vivo modali- ties, we would not be where we are today without the technological advancements of the past 30 years. Estimating infrastructure needs and achieving scale are not the only hurdles that cell and gene t he r apy de ve lop e r s now f ac e. Success will also depend on reduc- ing the cost of material goods for products, and maintaining consis- tent quality standards for the deliv- ery of live biologic material within the stringent profile characteristics required for commercialization. At this point, cell and gene ther- apy is still mainly driven by man- ual processes. Innovators will need to shift to a mindset based on mass customization. Every patient in the future will be different and will need to be treated in a different way. However, developers will have to produce a single, customized product with the same efficiency and quality used to mass-produce product. FROM MANUAL PROCESSES TO MASS CUSTOMIZATION Having standardized processes in place will be a competitive differ- entiator for CDMOs that operate in the cell and gene therapy space. For example, autologous therapies will require disruptive solutions necessary to deliver on the prom- ise of personalized medicines and move the industry from the stan- dard of "one batch for many" to "one batch per patient." For alloge- neic therapies, CDMOs will look to leverage the expertise and experi- ence acquired in large-scale manu- facturing of biologics to drive the commercialization of these ther- apies, making them in a scalable manner so they can be available to large patient populations. In order to achieve these results, the industry as a whole must work together in a three dimensional "cubic effect" to drive improve- ments across: • Technical performance • Input factor cost • Operational performance. Although technology is import- ant, improvements will be needed on the operational side. In order to deliver and treat patients in a more robust, safe, and cost-effec- tive way, innovators and their con- tract partners will need to define and improve the way that they approach the following, in the cell and gene therapy space: • Def in ing good ta kt t ime (i.e., the time between the start of production of one item and the start of produc- tion of the subsequent unit) • Aligning operations to the shift in labor needs • Def ining operations in a closed system for efficacy and safety • Reducing raw material costs • Reducing overhead costs. This shift in focus has already occurred in other aspects of life sciences, so we know that it can be applied to cell and gene ther- apy. Consider, for example, the fact that it used to cost over $30,000 to ma nu fac t u re just one g ra m of a standard mAb. Within two decades, CDMOs, working with innovators within the framework of the cubic effect, brought that cost down to under $10. CONCLUSION I n shor t, c e l l a nd ge ne t he r- apy innovators a nd t heir con- tract partners need to focus on ma nu fac t u rabi l it y a nd process industrialization as early in the development cycle as they can, to avoid a te c h n ic a l deve lop - ment bottleneck. Developers can greatly benefit from working with CDMOs, not only for traditional capacity but also to de-risk their path to commercial launch and to help them manage the unpredict- ability of demand associated with the curative nature of cell and gene therapies. Focusing on technical developments and the cubic effect must guide CDMOs as they work with smaller biotechs, who are at the heart of what the industry is trying to accomplish with meeting unmet medical needs. REFERENCE 1. IQVIA Institute, "Emerging Biopharma's Contribution to Innovation: Assessing the Impact," p. 13, June 2019. BP Partnerships for Outsourcing Manufacturing Having standardized processes in place will be a competitive differentiator for CDMOs in the space. It used to cost over $30,000 to make one gram of a standard mAb. Within 20 years, CDMOs, working with innovators within the framework of the cubic effect, brought that cost down to under $10.

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