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32 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2019 P h a r mTe c h . c o m pies, while they can present challenges related to distribution and shelf life, might be less challeng- ing compared to CAR-T cells and other autologous therapies, given their similarity to cell-based pro- teins that can be produced in batches and distrib- uted for use off the shelf. The class of drugs known as radiopharmaceuticals, which have extremely short shelf lives, have shown that this challenge can be well managed. Cellectis is exploring new production strategies for off-the-shelf allogeneic therapies. Rather than developing CAR-T cell ther- apies from patient samples, the company is using healthy donor T cells, which could allow for ear- lier supply chain preparation, better control over production volume, and, potentially, reduced costs. Production of gene and cell therapies can ... require customized technologies and innovations in production that require the active review and contributions of regulators and ... outside consultants to achieve target goals. Accessing new technologies and resources As the range of new options in technology expands, companies will continually need to access new levels of skill and insight to identify and acquire the innovations necessary to support production goals at every stage through commercialization. Generally, by Phase II, manufacturers should at least be aware of the technologies they will need to achieve target goals in scalability and be pre- pared to make these investments at the appropriate time. By Phase III, the full range of technologies that companies will need to support commercial production should be in place. Many industry in- siders expect that there will be greater demand for advanced technologies including, among others, cryopreservation tools and services, and that de- velopment of biomarkers and related diagnostics will become more common and even essential tools in the successful commercialization of gene and cell therapies (3). To identify the optimal options in technology, many manufacturers are now considering engag- ing contract research organizations (CROs) that have specialized expertise in gene and cell thera- pies, especially for those targeting rare diseases. Some CROs are now well positioned to provide guidance related to regulatory compliance, pro- duction scale, and product portability for gene and cell therapy developers. Their teams can provide guidance on how to refine manufactur- ing processes while maximizing purity and safety with a focus on continuity of care. One example of this type of collaboration is seen in the alliance between the Center for Commercialization of Re- generative Medicine, GE Healthcare, and the Fed- eral Economic Development Agency for Southern Ontario, which joined forces to form the Center for Advanced Therapeutic Cell Technologies in To- ronto. The Center was established to help industry partners incorporate new technologies and provide expertise to solve manufacturing challenges, espe- cially for emerging gene and cell therapies (4). Maximizing commercial opportunities When planning for manufacturing needs, drug developers should also consider using a produc- Manufacturing