Tapping into the Potential of Biologics

Research efforts are continuing to expand in the area of biological therapies. These large-molecule drugs are proving to be significant revenue drivers for bio/pharma companies and are providing therapeutic options for disease areas that have previously suffered from unmet medical needs (1).

Additionally, biologics are useful in providing more targeted disease treatment when compared with small-molecule drugs and lessening the risk of side effects for patients. The targeted nature of these large-molecule therapies is explored in this issue’s cover story, featured on pages 7–11, along with the potential that technological advances hold in pushing future boundaries and some of the challenges facing both the development and manufacture of biologic drugs (2).

Advanced therapy medicinal products (ATMPs), which are promising and often curative biologic therapies, face their own specific development and manufacturing challenges. Scalability of manufacturing for these emerging therapies is a particular bottleneck and something that San Francisco-based Cellares, a self-titled integrated development and manufacturing organization (IDMO), has sought to change. In an interview with Pharmaceutical Technology^® Group, Fabian Gerlinghaus, CEO and co-founder of Cellares, detailed how the company’s Cell Shuttle platform and integrated consumable cartridge automated platform can improve scalability of ATMP manufacturing (3).

The IDMO has also garnered interest from Bristol Myers Squibb (BMS), which joined the Technology Adoption Partnership (TAP) program in August 2023 (4). Participation in the TAP program has meant that BMS can use Cellares’ automated manufacturing platform for the manufacture of its pipeline products.

Most recently, in April 2024, BMS and Cellares built upon their relationship by entering into a deal worth $380 million, where Cellares will transfer select chimeric antigen receptor T-cell therapies onto its manufacturing platform, with the aim of meeting growing demand and improving turnaround time (5).

References

1. Bender, M. Pharmaceutical & Life Sciences Trends 2024. Hortoninternational.com (accessed April 24, 2024).
2. Thomas, F. Looking to the Future of Biologics. BioPharm Int. 2024, 37 (5), 7–11.
3. Spivey, C. Cellares Innovates with Automated Cell and Gene Therapy Platform. PharmTech.com, March 7, 2024.
4. Cellares. Cellares Announces Bristol Myers Squibb has Joined Technology Adoption Partnership Program to Evaluate Automated Manufacturing of CAR-T Cell Therapy on the Cell Shuttle Platform. Press Release, Aug. 28, 2024.
5. Cellares. Bristol Myers Squibb and Cellares Announce a $350M Worldwide Capacity Reservation and Supply Agreement for the Manufacture of CAR T Cell Therapies to Bring the Promise of Cell Therapy to More Patients, Faster. Press Release, April 22, 2024.

About the author

Mike Hennessy Jr. is the President and CEO of MJH Life Sciences®.

Article details

BioPharm International
Vol. 37, No. 5
May 2024
Page: 6

Citation

When referring to this article, please cite it as Hennessy, M. Tapping into the Potential of Biologics. BioPharm International 2024 37 (5) 6.