Issue link: https://www.e-digitaleditions.com/i/1468049
20 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Biologics therapies, reaching patients both from manufac- turing requirements as well as [from a] health, economics, regulatory, and supply chain perspec- tive. The manufacturing and administration of living therapies that have the potential to cure diseases [have] triggered a complete shift in how therapies should be evaluated. Moran (The Center for Break-through Medicines): The significant breakthroughs include process automation that is fully integrated with equip- ment, closed disposable systems for a variety of processes, and f lexible facility design with a modular approach. Building on these foun- dational needs will allow manufacturers to f lex and support different platforms such as plas- mids, viral and non-viral vectors, and autolo- gous and allogeneic cell therapies. This can be further expanded to in-line analy tics, to meet the ever-evolving demand. What's on the horizon for CGT PharmTech: What trends are you seeing in the CGT space? Hewitt (Charles River): Therapeutic developers have been watching the f ield and [have] seen that [CMC] issues have been the focus of many regulatory delays. Because of this, we've seen a renewed focus on ensuring analy tical meth- ods are able to be implemented for commercial products. The regulators have been clear they will require analytical methods that are able to consistently measure product critical quality at- tributes (CQAs). Certain cell therapy modalities are more difficult than others when doing this development, such as unmodified tumor-infil- trating lymphocytes (TILs), to identify reliable cell characterization and mechanism of action (MoA) potency/functionality assays. Even [with] this, many are making progress. Durdy (Cell and Gene Therapy Catapult): It is encour- aging to see that there [are] now more upfront thoughts about data and data handling. The im- plementation of comprehensive manufacturing execution systems and integrated digital systems is traditionally embarked upon in readiness for commercialization once the manufacturing pro- cess is completely tied down and just requires churning out the same process over and over again. In CGTs, it is being embarked upon earlier and earlier in the phase of clinical development; it is not unusual for an MES [manufacturing ex- ecution system] to be considered in Phase I. Moran (The Center for Break-through Medicines): Manufacturing facility design is evolving to ac- commodate [the] f lexibility required to address shif ting needs in t he marketplace. Manufac- turing facilities will need to be f lexible multi- product facilities that can manufacture a variety of advanced therapeutics. There will be more exploration into non-v ira l deliver y met hods and more patient-focused processes, requiring a greater level of adaptation than ever before. Improved tropism, vector and capsid design, and delivery mechanisms will have a dramatic impact on the field as well as better production methods that result in higher yield in both up- stream and downstream. Xu ( Ther mogenesis): In t he past, t rad it iona l chemical or small-molecule drugs were made for millions or billions of people. Cell and gene therapies are persona lized drugs, using your own cells, and are specif ically made for each individual … Current infrastructure only can handle thousands of patients. We need infra-