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8 BioPharm International ® Emerging Therapies 2022 eBook www.biopharminternational.com Flexibility to scale With more modality and scale diversity than ever before, it's important to build in flexible and resilient solutions that allow researchers to have the ability to scale where needed. One way to look at the scale of manufacturing is to estimate market size, the uptake of a potential ther- apy, and the dosing strategy, and then calculate back- ward from that. Investing in f lexible manufacturing processes will make it possible to grow, allowing a small fast start with something that is easy to scale up or out. To avoid problems later in the process, consider man- ufacturability and scaling up from the beginning. A protocol or method that quickly gives a pure product for early clinical material might be great, but if it can't scale up or be used in manufacturing, this will be an issue. Manufacturability includes assessing material suitabil- ity and thinking about material sourcing early. Contin- uous planning, a close relationship between customer, manufacturer, and supplier as well as regular communi- cation with suppliers are critical for the rapid expansion of manufacturing facilities. It is also essential to know the quality attributes of the product; so, early thinking on QC testing can save time later in the process. There are a few steps that manufacturers can take to reduce unknowns. Networking and collaboration are essential, such as communication and engagement with scientists, to stay informed on what is in the pipe- line and innovations in manufacturing techniques. Ma nufact urers ca n bui ld f lex ibi lit y into t heir processes by ensuring equipment is scalable and supports the transfer from process development into GMP manufacturing. For a manufacturing line, organizations can model different scenarios to ensure that the core equipment will perform in the range needed to reach the goal. The greatest flexibility is usually achieved with equipment that has a single-use f low path that can be sized for each product. The modeling will also show where you should scale out instead of scaling up. Think flexibility and optimized manufacturing for an investment. Future strategies for therapeutics will rely on a toolbox, including product innovations and applica- tion data for antibody variants and novel therapies. Researchers are continuously developing support for current and future molecules. This diversity requires an agnostic platform approach. ■ Drug Solutions Podcast: How Pfizer Views Partnering and Investing for Emerging Therapies BioPharrm International's sister publication, Pharmaceutical Technology, presents the Drug Solutions podcast, where the editors chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Experts share insights into the technologies, strategies, and regulations related to the development and manufacture of drug products. In a podcast that aired on Sept. 6, 2022, Chris Spivey, BioPharm and PharmTech's editorial director, interviewed Uwe Schoenbeck, senior vice president and chief scientific officer for emerging science and innovation at Pfizer. Some of the areas discussed include repeat expansion disorders, senescence, DNA damage response and nucleic acid sensing, deubiquitinase pathways, and neuroinflammation. Pfizer feels these hold special promise for new innovative therapies. Through research collaborations, consortia, licensing, investments, and acquisitions, the emerging science and innovation team at Pfizer seeks to harness external, cutting-edge preclinical assets and novel technologies in emerging therapies. Increasingly, the focus is on true first-in-class mechanism, if not only in class programs, that would allow us to bring real breakthroughs to patients. Visit PharmTech.com/drug-solutions-podcast to learn how Pfizer's external-facing research and development scientists uncover the most promising emerging therapy concepts and ideas in thepharmaceutical landscape. — The editors of BioPharm International How Pfizer Views Partnering and Investing for Emerging Therapies September 6, 2022 PharmTech.com/drug-solutions-podcast