The Build Versus Buy Decision
For cell therapy companies, the decision to build capacity or outsource it to a contract development and manufacturing partner is one of the most critical and complex choices facing the organization. What makes it so complex? The choice must be made years prior to reaching commercialization, weigh numerous factors, and be made without the luxury of a complete set of data and knowledge of the therapeutic candidate.
do you roll the dice and decide now without the luxury of complete information, or wait for data and incur the risk and cost of a technology transfer following the pivotal study?
Often, this decision is made when the clinical candidate is in the early stages of development and efficacy data are limited. A double-edged sword may also loom as phase 2 clinical trials can potentially serve as registrational studies for cell therapies that show exceptional promise. This is certainly a welcome situation for company and patients alike. In these cases, however, the clock is ticking faster and more loudly, further abbreviating the build versus buy decision-making timeline. Is there even time to consider building capacity – given that it can take 2-3 years to construct a greenfield facility? Undoubtedly, the ideal situation is that manufacturing for the registrational trial takes place in the commercial facility, eliminating the need for a technology transfer post marketing authorization. So, do you roll the dice and decide now without the luxury of complete information, or wait for data and incur the risk and cost of a technology transfer following the pivotal study? When the product is the process and comparability and consistency can be challenging, as is the case with cell therapies, opting for the latter can be particularly risky.
In a recent article, explored this question of timing, along with several other considerations that are foundational to the build versus buy evaluation.
Capital Investment
The choice of capital investment may seem, at its surface, to be straightforward. The cost to build a cell therapy facility may appear low in terms of the fundamental equipment requirements. Having your own facility also enables full control over intellectual property and manufacturing process know-how. But these “pros” must be weighed against the “cons”. Operating costs are high and continue even when the facility is idle. The costs of information technology (IT) and digitalization must be considered and can be significant, with perhaps up to a dozen systems to purchase, configure, implement, and maintain. While large, established biotech companies are likely to have these systems in place, emerging companies may only have foundational corporate functions such as finance, human resources, and payroll. An additional consideration with emerging companies is that the preference for deployment of human resources and equity capital is typically toward scientific discovery and development and not bricks and mortar.
Institutional Knowledge
Institutional knowledge and staffing are two additional considerations. The knowledge accessible via an experienced CDMO with expertise in a broad range of cell types, novel cell product processing, analytical technologies, and the regulatory landscape is invaluable. Regulatory guidelines governing cell therapy product manufacturing are still evolving and for an early-stage company they can be challenging to navigate. For example, the US Food and Drug Administration (FDA) has indicated they are tightening expectations with regard to chemistry, manufacturing, and controls (CMC) of cell therapy-based products. For a new cell therapy company, limited experience in this area can increase the exposure to risk and subject the organization to delays due to regulatory feedback. In this situation, partnering with an experienced CDMO can save time and avoid costly detours. In addition to regulatory expertise, the CDMO can determine which manufacturing platforms would offer the best fit for a specific process and will most likely already understand if the chosen technologies and platforms are scalable and well-suited for the cGMP environment.
Staffing
The ability to attract and retain the required amount of staffing is another piece of the build versus buy puzzle. Hiring skilled scientists, engineers, operators, and support teams to run a cell therapy manufacturing facility is increasingly difficult, time consuming, and expensive. And with a growing number of cell therapy companies chasing a limited talent pool, the difficulty is compounded. All of this can add up to a significant expenditure for companies planning to build versus outsourcing. By engaging with a CDMO, the product sponsor avoids the costs associated with hiring, compensation, benefits, training, and turnover.
Looking Forward
Without a doubt, cell therapy represents a revolutionary new pillar in treatment of disease. Thousands of companies and clinical trials are advancing towards the market approval finish line. Along the way, a fork in the road forces a choice between building internal capacity or outsourcing. There is risk and uncertainty and finding the best solution for your organization requires a deep dive into many factors. We’ve outlined just a few of the key considerations and encourage you to download the ebook on the topic for further exploration. With a clear view of what must go into this possible make-or-break decision and the available options, the right answer will reveal itself.
