Positioning Cell Therapy Manufacturing for Success: Supply Chain Requirements | Part 2

January 25, 2021

Cell therapy is an exciting new faucet of regenerative medicine that provides patients with effective solutions to their healthcare issues. Cell therapy supply chains require close monitoring for companies to provide the best treatment options. 

For companies to provide excellent cell therapy options to their clients and patients, they must use premium raw materials and have a robust, quality cell supply. 

Cell Therapy Manufacturing Process

In response to advances in the cell manufacturing industry, companies are scrambling to produce cost-effective, large-scale methods of delivering a complex product to their patients. 

The process usually begins with harvesting cells from the patient and ends with a viable product. In between these phases, manufacturing companies must identify and assess the cells’ critical quality attributes.¹

Cell therapy manufacturing companies use in-house testing standards to validate the efficacy of the contributions. If possible, companies harvest, produce, and store more doses onsite. 

Eventually, after maturation, cell therapy products are thawed and delivered to the patient. The quality of the product depends on the efficiency and consistency of the supply chain management in cell and gene therapy products in addition to the source of the cells. 

With the right supply chain management tools and techniques, cell therapy manufacturing companies can provide patients with the very best products

Differences in Cell Therapy Sources

There are two types of cell therapies, and the distinction between them stems largely from the source of the cells. 

In allogeneic cell therapy manufacturing, cells are taken on a large scale from an anonymous donor. These therapies can treat thousands of patients with a single batch.² Since the cell therapy product is created on such a large scale for a broad audience, quality control can be administered throughout the process. 

In these large-scale therapy productions, cell therapy product preservation and distribution are the main concerns in the supply chain. 

On the other end of the spectrum, autologous cell therapy manufacturing produces solutions for patients using their own cells. In a sense, each cell therapy product is custom made for the patient. One of the most important aspects of this particular process is maintaining the chain of the patient’s identity of the samples. 

In this scenario, the cell therapy product is produced on a small scale, close to the patient’s point of care. The associated manufacturing costs can be diminished by increasing and replicating the way that these therapies are produced, even if the product itself is highly specific and only used by one patient.³

For both processes, transporting and delivering the cells from the patient to the labs, and back to the patient again, requires utmost care. Regardless of the production scale, handling such delicate materials requires an unbroken cell therapy supply chain and the right quality-protecting practices.

This is where the supply chains of these two processes diverge. In autologous cell therapy, the patient’s location is known from the outset. However, with allogeneic cell therapy, the product is manufactured and delivered to a vast web of caregivers and patients, many of whom are located far away from the site of clinical trials or cryopreservation. 

Autologous Stem Cell Based Therapies BioStem lifescience

Downstream Processing

Having custom downstream systems in place is critical to the cell therapy supply chain. Downstream processing entails reducing and removing any contaminants with chromatographic technology, unique filtration systems, and centrifugation. 

Downstream processing is a key component in cell therapy production. Care during cell transportation and processing implementation is extremely important to ensure the product remains pure and safe throughout the entire manufacturing process. 

Cell therapy manufacturing companies must establish a viable supply chain for cells as well as the tools, supplies, and reagents used in the purifying processes. A trusted CDMO will monitor every step of the supply chain to ensure efficacy and quality. 

From Clinical Trials to Scalable Products

Many cell therapies are developed in clinical trials without considering how the product can be scaled into a viable pharmaceutical production scheme. Protecting the security and purity of a few hundred units of a therapeutic product is much different than looking out for quality control as you manufacture thousands of units of a product. 

Automated processes can improve the efficiency of manufacturing processes and reduce the risk of contamination. Experienced CDMOs can also take over production to scale the product from small to large-scale production.   

The Final Word

Cell therapy is opening doors to effective treatment options for people around the world. The supply chains involved in allogeneic and autologous cell therapy manufacturing processes must be carefully monitored to ensure the purity and quality of the final products.

Although establishing a secure manufacturing supply chain is only one piece of the puzzle in cell therapy manufacturing, it is undoubtedly a vital step. Contact BioStem Life Sciences, a trusted cell therapy manufacturing company, for quality, reliable treatments. 

Sources:

(1) National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Regenerative Medicine. “Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop.” Washington (DC): National Academies Press (US); 2017 Oct 26. 3, Identifying and Measuring Critical Quality Attributes.  

(2) Pigeau, G. M., Csaszar, E., & Dulgar-Tulloch, A. (2018). Commercial Scale Manufacturing of Allogeneic Cell Therapy. Frontiers in Medicine, 5, 233. 

(3) Lopes, Adriana G., et al. “Analysis of Cost of Cell Therapy Manufacturing: Autologous Cell Therapies, Part 1.” BioProcess International, BPI, 4 May 2018.


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