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Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 33 Capacity expansions and collaborations CDMOs have been adding capacity for both development and commercial scales to meet the expected demand for spray drying. In November 2021, Hovione announced that the company would add commercial spray-drying capacity and equipment as part of its expansion at its facilities in the United States, Ireland, and Portugal (2). At the US facility in NJ, the com- pany is constructing a new building and will have additional commercial spray drying capacity online by 2023. New com- mercial spray dryers are also slated for the Cork, Ireland and Lisbon, Portugal facilities. Catalent acquired the manufacturing and packaging op- erations of Acorda Therapeutics, Inc. in January 2021, in- cluding a 90,000-ft 2 CGMP facility in Chelsea, Mass. with spray drying capacity that provides Catalent with significant commercial-scale capacity for new customer programmes. Catalent said that the Chelsea facility will act as a global cen- tre of excellence within the Catalent network for spray-dried dispersion and dry powder encapsulation and packaging (3). Catalent also announced a manufacturing collaboration with clinical-stage pharmaceutical company DisperSol Technolo- gies in August 2021 (4). DisperSol's clinical products are made using its proprietary KinetiSol ASD platform. As part of the collaboration, DisperSol transferred its technology by setting up its proprietary equipment in a dedicated suite in Catalent's Somerset, NJ facility. Catalent is providing staff for development, scale-up, and commercial-stage KinetiSol production. Conclusion Spray drying is suited to ASDs but is also finding use in other fields, such as microencapsulation, nanotechnology, and vac- cines. "Spray-drying stands out as an accessible, repeatable, and scalable process that offers developers a cost-effective way to improve the solubility and bioavailability of their formulations," Van Vooren concludes. References 1. Hovione, " Hovione Launches ASD-HIPROS," Press Release, 12 Jan. 2021. 2. Hovione, "Hovione Invests $170 million in New Capacity and Capabilities," Press Release, 11 Nov. 2021. 3. Catalent, "Catalent Agrees to Acquire Dry Powder Inhaler Spray Drying, Capsule Manufacturing, and Packaging Capabilities from Acorda Therapeutics," Press Release, 13 Jan. 2021. 4. Catalent, "DisperSol and Catalent Collaborate to Establish Ki- netiSol Technology Manufacturing Hub for DisperSol Pharma- ceutical Pipeline," Press Release, 2 Aug. 2021. PT New tools may be able to address the challenge of API volume at early stages. Additionally, vaccines that rely on mRNA technologies provide the added benefit of having the potential for inex- pensive, rapid, and cost-effective scalable manufacturing. As mRNA can be synthesized using relatively simple in vitro transcription reactions, high yields can be achieved with a small, good manufacturing practice (GMP) facility footprint. As a result, mRNA technologies are being used in abun- dance in drugs currently at clinical trial. As of July 2021, there were more than 70 mRNA therapeutics in clinical pipelines globally and many more assets in early develop- ment (7). The therapies in development are to be used in an array of therapeutic areas. These include drugs for can- cers (ovarian, lymphomas, melanomas, and glioblastomas), ischemic heart disease, rare diseases (caused by Zika virus, Chikungunya virus), and more common diseases (caused by Rabies virus, HIV) (8). It is likely that demand for manufacturing support will persist for years to come, especially with the immediate need for COVID-19 booster vaccinations. CDMOs will need to keep adapting to solve the challenges associated with the storage of mRNA technologies, as well as develop their ser- vices to provide end-to-end mRNA capabilities. Overcom- ing these issues may in turn position the manufacturers in a stronger position to support other therapeutic modalities such as C>s further on the horizon. Lessons learned and moving forward With an increased demand for drugs based on new tech- nologies, CDMOs will need to consistently demonstrate their agility while ensuring quality and safety in all stages of a product cycle. This is essential to respond to other new technologies and shifting market dynamics. To achieve this, processes will need to be highly optimized to reduce time- lines and provide speed to market. The pandemic has highlighted that foresight, careful preparation, and agility continue to be essential traits for CDMOs and will prevent them from mismanaging their priorities. Client satisfaction and the lives of patients are, and always should remain, the highest priorities. References 1. W. Xie, B. Chen, and J. Wong, Nat. Rev. Drug Discov., 20, 735–736 (2021). 2. FDA, Emergency Use Authorization, Policy Framework [content current as of 25 Jan. 2022]. 3. FDA, Priority Review information available from fda.gov [con- tent current as of 4 Jan. 2018]. 4. EMA, Conditional Marketing Authorization information avail- able from ema.europa.eu [accessed 25 Jan. 2022]. 5. D. Stanton, "Single-Use Lead Times up to 12 Months as COVID Takes its Toll," BioProcess International, 3 May 2021. 6. J. Feinmann, BMJ, 375 (8312) n2375 (2021). 7. Statista, "Number of mRNA Therapeutics in Clinical Pipelines Worldwide as of July 2021, by Therapy Area," Statistics (July 2021). 8. NIH, ClinicalTrials.gov, Database [accessed 15 Nov. 2021]. PTE Manufacturing — Contin. from page 29