5.1.1 Even if 50–75 cell and gene therapies receive FDA approval by 2030, questions remain as to whether they will achieve commercial success. Safety issues with different viral vector gene delivery vehicles that have occurred in the past few years must also be addressed. Demonstration of long-term safety and efficacy must be achieved as well.
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5.2.1 Artificial intelligence (AI) and machine learning (ML) have the potential to help overcome challenges in the cell and gene therapy field, including their complexity and heterogeneity with respect to therapeutic approaches, the supply chain, logistics, and so on. Companies looking to leverage these digital tools for cell and gene therapy development include Modulus Therapeutics, Outpace Bio, Serotiny, Dyno Therapeutics, and Patch Biosciences.[86]
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5.3.1 Despite being the established standard for delivering therapeutic DNA to cells both in vivo and ex vivo, viral vectors do have disadvantages, of which the complexity and cost of their manufacture is only one. Other notable disadvantages include concerns around toxicity and immune response; the latter being particularly problematic for AAV-based gene therapies that can currently only be administered once, since the patient’s immune system would fight a re-dose before it had time to exert any therapeutic effect. This can also exclude some patients from even a first dose using some AAV serotypes if they have had previous natural exposure to the virus.
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5.4.1 One of the ongoing challenges in the biomanufacturing industry is a serious labor shortage. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public–private partnership that was founded in 2017 to study, highlight, and address the challenges in the industry.[89] In 2022, NIIMBL published a study in which they surveyed manufacturers across the U.S. and found the talent shortage to be ubiquitous.[90] While the shortage is felt across all levels of biomanufacturing organizations, it is striking that only 42% of job postings for manufacturing associates require a bachelor’s degree.[90] Traditionally, firms across industries will pay relocation fees for high-level employees such as managers and above, but relocation support for entry-level employees without a college degree is rare. Companies are left, then, to recruit from local talent for entry-level manufacturing associates jobs while they simultaneously compete nationally (or even globally) for more educated talent.
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5.5.1 In the last few years, the pace of innovation in cell and gene therapy manufacturing has been unremitting, bringing several possible solutions to the challenges associated with cost-effective manufacture of advanced therapy medicinal products (ATMPs) closer to clinical reality.
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