CMOs and the Speed of Personalized Medicine

In the growing field of personalized medicine, there are significant opportunities for contract manufacturing and development organizations (CMOs and CDMOs). The challenge is keeping up with demand while staying ahead of the competition – and the solution is adopting the right technology.

Rise in Demand and Opportunity

In 2005, personalized medicines accounted for 5% of new therapies approved by the U.S. Food and Drug Administration (FDA) each year, and that number has seen a sharp increase.⁽¹⁾ Last year, personalized medicines accounted for 39% of new drugs approved by the FDA, and personalized medicines have accounted for more than 30% of drug approvals during three of the last four years.⁽²⁾

The rise in demand for personalized medicine creates opportunities for CMOs and CDMOs.

Tim Wright, editor of Contract Pharma, explained the new era of targeted therapeutics in cell and gene therapy is still young, but the need for contract manufacturers in personalized medicine will continue to grow – the FDA anticipates that by 2025, it could be approving 10 to 20 cell and gene therapy products each year. “While pharmaceutical companies are adding cell and gene products to the pipeline, they are increasingly looking to contract service providers who can offer development and manufacturing capabilities and expertise in the area,” he said.⁽³⁾

Move to High-Mix, Low-Volume Manufacturing

Two major factors in the mounting opportunities for CMOs and CDMOs in personalized medicine are:⁽⁴⁾

1. A shift in the pharmaceutical industry from large-scale production to niche and targeted therapies.
2. The demand for flexible operational capabilities, production scales, and multiple product operations.

These factors were recently noted by President and Founder of the Pharma and Biopharma Outsourcing Association, Gil Roth, who said personalized medicine is a major part of the future of drug manufacturing.

“This focus on treatments intended for smaller patient populations can have a range of effects on drug manufacturing, and the decision to work with CDMOs, as well as the investments that CDMOs make. These things shift production away from the traditional large batch, large volume of products and head towards smaller batches or again, in some cases, individualized treatments,” he said.

Roth went on to elaborate on these changes in production and their potential benefits.

“Products for small patient groups create a different set of manufacturing demands and business models, with shorter runs and facilities and operations that must go patient to vein in short order. CDMOs are learning to accommodate these new demands and they create opportunities for nimble, well-run manufacturers,” he said.⁽⁵⁾

Gain Scalability and Efficiency

As Roth said, nimble manufacturers have a lot to gain by working in personalized medicine. Scalability is a large component of being nimble, and it requires a digital manufacturing solution. Digitization offers scalability while making it easy to manage recipe changes, variations, and substitutions quickly and efficiently.

The advantages of a digital solution are numerous. You can ensure data integrity, streamline compliance, and release a quality product faster. The increase in quality makes it easier to get ahead of the competition because companies are relying on you to provide them with the technology the need to ensure personalized medicine continues to move forward.

“Currently there is not enough capacity to meet the demand to support diseases with large patient populations,” Steve Pincus, head of innovation at Fujifilm Diosynth Biotechnologies (FDB) in Texas, said. “This is where the scalability approach comes into place. We also see that there are some challenges around the testing requirements for cell therapies – the time to get results and sample volume requirements. We’re seeing more and more CDMOs moving toward platform approaches for the delivery of gene therapies as a result.”⁽⁶⁾

To learn more about digitization and other 2021 trends in contract manufacturing, read “A Fast-Paced Industry is Picking Up Speed.”

Sources

1. “Personalized Medicine at FDA: The Scope & Significance of Progress in 2019,” Personalized Medicine Coalition.
2. “Personalized Medicine at FDA: The Scope & Significance of Progress in 2020,” Personalized Medicine Coalition.
3. “The New Wave of Innovation,” Tim Wright, Contract Pharma, June 4, 2020.
4. “Biopharmaceutical Contract Manufacturing Market to 2027 – Global Analysis and Forecasts by Product; Service, and Geography,” Insight Partners, March 2020.
5. “Keynote: The Future of Drug Manufacturing,” by Dong Soo Kang and Gil Roth, CPHI festival of pharma®, October 5-16, 2020
6. Supra note 3.