Alternatively, a startup wanting to bring production in-house can hire consultants to design and construct its new facility that will meet GMP requirements and include the necessary support functions to manufacture CGTs at scale.
Larger biopharmaceutical companies are more likely to use internal manufacturing or a combination of internal and outsourced production. This occurs because established companies—even those new to the CGT sector—have the capacity and workforce to bring drug products to market and are likely to have more capital available to build a new facility.
Manufacturing capacity continues to constrain production
Biopharmaceutical companies looking to outsource CGT production are hampered by the continued industry-wide lack of availability of manufacturing space. In fact, there can be up to a two-year wait to rent manufacturing space from a CDMO, which is a challenge for those unable to project their process requirements that far in advance while still working through process development. Building internal capacity becomes more attractive in these conditions.
The decision hinges, largely, on predicting the probability of a successful clinical trial. If a company is bullish about the prospects of its therapy, then it needs to decide whether to reserve future space at a CDMO or begin a feasibility study for building its own facility.
Building a new facility, or retrofitting an existing one, however, also impacts the schedule of commercialization. It involves design, construction, and commissioning qualification, a process that could take approximately two years. Additionally, 92% of the industry experts we surveyed indicated that they had experienced a shortage of consulting, design, and construction service providers, with almost one in five stating this shortage was extreme. Given this timeline, the earlier a company can plan its production strategy, the better, which also allows for building in strategic flexibility.