Cell therapy is the therapeutic approach which involves the injection of healthy cells in the human body, in order to replace the diseased / non-functioning cells to regulate certain functions. Driven by the benefits offered by cellular therapies and recent approvals by regulatory authorities, the demand for such therapies has increased considerably. This trend has further led to a rise in the requirement of cell therapy consumables. Cell therapy consumables are materials which are used in the manufacturing of cell therapies, however, do not form a part of the final product. Raw materials used for the production of cell therapies include culture media, growth factors, extracellular matrices and reagents.
Key Considerations for Manufacturing of Cell Therapies
Several factors influence the conversion of biological products into therapeutic interventions. Some of these have been listed below:
- Ethical consent and clearance
- Identification of scalable approaches for separation and purification
- Establishment of secure logistics / supply chain / tracking systems to ensure proper tracking of patient-specific products (within the manufacturing facility and while the product is en route to the clinic)
- Availability of cryopreservation and cold chain storage facilities. As mentioned earlier, biological products are usually less stable and need to be stored under a specific set of conditions immediately after their production
- Availability of specialized aseptic fill / finish capabilities, which are compatible for use with biological products
Role of Raw Materials in Cell Therapy Manufacturing
Based on the type of product, production process, and interaction of multiple materials during the manufacturing process, each cell therapy product may have unique raw material requirements. During the development of these therapies, raw material changes can be expected and the impact of these modifications on the final product must be assessed. Moreover, changes in raw materials at the end of a product’s life cycle can be costly and time consuming. Through the adoption of GMP or commercial grade materials, as early in the development phase as possible, it is likely to minimize the burden and impact of change. It is important to mention that manufacturing and control of cell therapy products relies heavily on the quality of raw material used during the development process. Therefore, to maintain a consistent supply of products for patients, well-characterized materials from trusted suppliers, combined with robust processes are essential.
Types of Cell Therapy Consumables
Raw materials used in the manufacturing of cell therapies can be classified as buffers, cell culture media, growth factors, kits, reagents and extracellular matrices.
It is worth highlighting that cell culture media is one of most critical factors influencing the production of cell therapies, both biologically and financially. Media is estimated to account for 15-20% of the total cost of cell therapy manufacturing. Therefore, for the production of commercially viable cell therapies, media optimization is one of the key factors. In order to achieve this, a paradigm shift is being observed from the use serum-containing media to serum-free and xeno-free media. This can be attributed to the fact that there is an urgent need to minimize the risk posed by serum. Media containing serum has undefined components due to which batch to batch inconsistencies arise, which lengthens the translation from preclinical to clinical trial phases.
The below table lists the various types of media formulations used in the manufacturing of cell therapies.
What are the key trends that are shaping up the cell therapy consumables market?
More than 450 cell therapy consumable products are offered by more than 80 stakeholders engaged in this domain. In addition, numerous partnerships were established in this domain, during the period 2015-2022.
Bottom Line
Keeping every trend in mind, Roots Analysis has provided complete information on market trends in cell therapy consumables domain, which has some of the very recent and precise activities listed for the clients to help them make better decisions in its report titled, Cell Therapy Consumables Market, 2022-2035. To find answers to key decision-making questions and to know further about the market forecast analysis, highlighting the likely growth of the Cell Therapy Consumables Market, for the time period 2023-2035.
You can also check out our report by visiting ‘Cell Therapy Media, Cell Therapy Kits, Cell Therapy Reagents and Cell Therapy Surface Market‘ section
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