Personalized treatments are the wave of the future in medicine. With regenerative medicine treatments like CAR-T cell therapy receiving FDA approval, the demand for the manufacturing of cell therapies is only going to continue to grow. However, there are unique logistical challenges in the cell therapy manufacturing process that are preventing these treatments from becoming streamlined. One solution that is available, and also growing in popularity, is for pharmaceutical companies to partner with a Contract Development Manufacturing Organization (CDMO), that has the knowledge, resources and technology to aid in moving the process along. It’s essential to choose the right manufacturing partner who can communicate effectively, and we will highlight the importance of trust in this relationship below.
Demand for GMP Cell Therapy on the Rise
To date, five CAR-T therapies have been approved by the FDA, including Yescarta and Kymriah. It’s expected that another 10-20 will be approved each year, which means that the demand for GMP manufacturing facilities and resources will continue to rise. With a Global success rate of 50-80 percent, CAR-T therapy is an effective treatment that has the potential to improve millions of people’s lives. It’s essential to work through the logistical challenges of the cell manufacturing process to make these treatments available to as many people as possible.
Challenges in the Cell Therapy Manufacturing Process
There are several bottlenecks that stand in the way of a seamless process in manufacturing cell and gene therapies.
- Cell processing safety – the many sequential steps in the cell manufacturing process need to be executed precisely. Each one, especially if done manually, involves a great deal of labor which can expose cells to a high risk of contamination.
- Manufacturing capacity – There is currently a shortage of facilities available to manufacture cell therapies that meet GMP standards, even through CDMO partnerships.
- Technical support – Many CGTs are invested heavily in their research and development, but in order to grow and meet the demands of their rising popularity, pharmaceutical companies need to invest in engineering and technology that will make scaling up and improving yields a possibility.
A successful CDMO partnership can help alleviate some of these challenges, and help move the CGT manufacturing process forward.
Cell and Gene Therapy CDMO Partnerships Offer a Solution
CDMOs are companies within the pharmaceutical industry that provide drug development and manufacturing services. They provide a solution for rapid, scalable manufacturing by using their resources, expertise and technology to facilitate steps in the cell manufacturing process that pharmaceutical companies can’t complete in-house.
The Importance of Choosing the Right CGT CDMO Partner
Finding the right CDMO partner is essential. Pharma companies are trusting an outside source with their confidential information, hard-earned research and data, and proprietary processes. In order for the partnership to be beneficial, it must be based on mutual trust and a great deal of communication.
By clearly communicating expectations, from both the company and the CDMO partner, it will help both parties resolve any misunderstandings and overcome any challenges that arise together.
Trust is Essential for End-to-End CDMO services
Rather than going to multiple vendors, cell therapy companies can benefit greatly from having one CDMO partner that can provide all of their outsourcing needs. To alleviate bottlenecks and ensure a seamless cell manufacturing process, companies must allow their CDMO partner the autonomy to do what they’ve been hired to do. They must share their classified information, and trust that their partner will keep their precious research confidential. Risks are also minimized by partnering with a team that has a great deal of experience.
About ThermoGenesis Holdings Inc.
ThermoGenesis Holdings, Inc. offers global infrastructure and proprietary manufacturing technologies to help alleviate some of the challenges that developers of CGT therapies face. A proprietary technology like the CAR-TXpress Platform provides high efficiency manufacturing for cell therapies. This state-of-the-art technology could potentially increase manufacturing efficiency while reducing manufacturing costs. Our BioArchive System also provides storage solutions for the valuable cell samples. It is one of the best cryostorage systems for clinical grade cell therapies and offers outstanding cell viability in the industry. Our X-BACS® technology is a novel, closed, semi-automated system that allows the selection of specific cell types. This is an excellent solution for CGT therapies that are in the development phase.