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10 Pharmaceutical Technology ® | BioPharm International ® Trends in Manufacturing May 2025 PharmTech.com CELL AND GENE THERAPIES Small to mid-sized companies increasingly are rec- ognizing the benefit of the IDMO approach. Technol- ogy transfer is relatively quick, and once processes are locked in, scaling to meet the new demand of each clinical or commercial product is straightforward. At the same time, they can leverage the benefits of au- tomation, including significantly lower batch costs and a reduction in the cost of goods. That scale-up can be over multiple geographies, which simplifies global clinical trials as well as man- ufacturing for disparate markets. It further reduces the need to move biological materials through cus- toms or plan for special regulatory inspections. FDA has been a welcoming partner for the smart factory approach through its Advanced Manufactur- ing Technolog y Designation Program (1). An auto- mated and fully closed CGT manufacturing platform was the first to receive the designation, which allows for establishment of a standardized reference base process that can streamline the drug development process (2). The AMT program lead to faster development time- lines, with particular relevance for therapies being developed for rare or orphan diseases. Commercial- ized CGTs for rare diseases have been at highest risk of being removed from markets globally. By reducing the need for developers to repeatedly demonstrate the robustness of identical processes over multiple therapies, IDMOs can cut both development costs and regulatory red tape. Ultimately, the promise of the IDMO is to acceler- ate access to life-saving cell therapies for all patients in need. Patients are not concerned about how their drug is manufactured, so long as it is safe, efficacious, affordable, and available when they need it. As such, the IDMO model is well positioned to solve the CGT bottlenecks. This will allow therapeutic developers to focus on what truly matters to their patients and not the manufacturing process, which will further drive drug development innovations across thera- peutic indications. References 1. FDA. Advanced Manufacturing Technologies Desig- nation Program, Guidance for Industry (CDER, CBER, December 2024). 2. Cellares. Cellares' Cell Shuttle Receives FDA Ad- vanced Manufacturing Technology (AMT) Desig- nation for Automated Cell Therapy Manufacturing. Press Release. April 1, 2025. ■ Small to mid- sized companies increasingly are recognizing the benefit of the IDMO approach. For more videos, visit PharmTech.com! Drug Digest: Keeping Pace with Progressive Technologies in Biopharma Development The biopharma industry is at a time where progressive technologies such as artificial intelligence, machine learning, and digitalization technologies are making a significant impact on how drug discovery, development, and manufacturing are being driven. Yet the question remains as to how the industry itself is keeping up with the fast-paced innovation churning out from these advanced technologies. This episode of Drug Digest will examine where the significant bottlenecks are in the development and manufacturing of new molecules resulting from these progressive technologies, and how best to approach these challenges. Panelists include Kevin Dondarski, principal, Life Sciences R&D, Deloitte Consulting; Maryland Franklin, PhD, vice-president and Enterprise Head, Cell and Gene Therapy, Labcorp; Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions; and Sean Tucker, PhD, founder and chief scientific officer, Vaxart. https://www.pharmtech.com/view/drug-digest-keeping-pace-with- progressive-technologies-in-biopharma-development