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www.biopharminternational.com Manufacturing and Facilities 2022 eBook BioPharm International ® 23 Cleanrooms First option—CMOs/CDMOs CMOs/CDMOs are a viable solution for manufacturing needs and capabilities that can suit various industry sectors/niches within the bio/pharmaceutical indus- try. CMO/CDMOs provide companies with drug devel- opment and drug manufacturing services based on a contractual agreement and relationship. Before partnering with a CMO/CDMO, drug devel- opment organizations must ensure they have the right partner to move their molecule forward. A recent report from Bourne Partners revealed that CDMOs are waitlis- ting organizations for 16 to 24 months (3). In addition to the waiting time for a manufacturing slot, a significant technology transfer has to occur prior to the onset of manufacturing operations at the partner CMO/CDMO site, which adds to the wait time for the product to be manufactured. These tech transfers also have a potential for failures, resulting in further delays. Once partnered, a significant benefit is that CMO/ CDMOs take on the entire manufacturing burden, including operators, equipment, and facility manage- ment. Several drawbacks come with this path, however, most notably a lack of control and f lexibility. Addi- tional challenges, such as coordinating and schedul- ing times, maintaining intellectual property security, working with complex tech transfer plans, and losing the flexibility to change the process as needed, accom- pany this path. Second option—DIY The second option—and one favored by mid- to large-size companies—is building one's own cleanroom facility. Companies that decide to go in this direction have full control over the intellectual property and have the abil- ity to make necessary changes to their process as needs arise. Additionally, by building their own facility, compa- nies can build custom-tailored facilities to meet specific manufacturing needs while maintaining quality control. However, building a new facility or expanding an ex- isting facility to make commercial quantities of medi- cines requires substantial planning and resources; this can cost up to $2 billion and can take 5 - 10 years to meet FDA standards for production (4). Expanding existing facilities, transferring a single product to a new man- ufacturing site, or retrofitting an existing facility for a new product can also take several years. While a desired pathway for some, this path takes a considerable amount of time and is a costly option that some companies, such as early-stage start-ups and small- size companies, don't have the capital budget or time to pursue. Building timelines may also be pushed out and placed on hold due to availability within the supply chain, which has become increasingly commonplace since COVID-19 (5). Additionally, the facility must be val- idated by the owner and comply with regulations that can take further time to approve. Third option—cleanroom licensing Rather than building their own facility or partnering with a CMO/CDMO, companies of all sizes are turning to a new hybrid model for manufacturing needs—clean- room licensing. This option allows companies to lease and customize cleanrooms for their specific manufac- turing needs. In addition to the cleanroom space, the licensing includes support services and removes the burden of facility ownership and maintenance, allow- ing companies to focus on their expertise—science. This route also enables companies to have full control over their intellectual property, with the flexibility required for product development and commercialization. It is also important to note that a cleanroom licensing organization offers early-stage companies added ser- vices. Because many start-up organizations originated in academia or research settings, these companies often lack depth in the operational aspects of manufacturing treatments and therapies at scale. Some of these ser- vices include materials management, storage and dis- tribution, facility current good manufacturing practice compliance, asset management, project management, quality control, and more. Additionally, cleanroom licensing has become a fa- vorable option for companies building their own facility and needing a bridge facility or companies needing ad- ditional capacity due to changes in development plans. In any scenario, the cleanroom licensing option trumps the traditional options of DIY or CDMO/CMO in terms of speed to manufacturing. As the market for new therapies, treatments, and medicines exponentially increases, so will the manu- facturing demands and needs within the industry. With a rise in tailored approaches to development within the pipeline, such as cell and gene therapies, cleanroom li- censing will thread the needle between the traditional options of manufacturing—DIY or CDMO. References 1. PhRMA, "Research & Development Policy Framework," www.phrma.org/policy-issues/Research-and-Develop- ment-Policy-Framework, accessed Oct. 31, 2022. 2. FDA, "Statement from FDA Commissioner Scott Gottlieb, MD and Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research on New Policies to Advance Development of Safe and Effective Cell and Gene Therapies," Press Release, Jan. 15, 2019. 3. Bourne Partners, Market Insight — Biopharmaceutical CDMOs Analysis Update (1st edition, August 2019). 4. N. Longo. "Setting up a Pharmaceutical Manufacturing Supply Chain Is a Complex and and Lengthy Process," Catalyst.phrma.org, May 14, 2020. 5. A. Cho. "Pandemic Lockdowns, Supply Shortages, and Inflation Wreak Havoc with Big Science Projects," Science.org, June 2, 2022. ■