A contract development and manufacturing organization (CDMO), is a company that serves cell therapy companies on a contract basis. Common cell therapy CDMO services include cell therapy product development, manufacturing, clinical trial support, and commercial supply.
CDMOs allows cell therapy companies to outsource aspects of their business, which can support:
- Speed to market
- Adding technical expertise without overhead costs
- Cost efficiencies
Over the past several years, the biopharmaceutical industry has witnessed an increasing number of contract suppliers taking on the CDMO acronym to identify their ability to assist at the development stage of drug manufacturing.
The CDMO acronym indicates that a company is interested in differentiating their abilities from contract manufacturing organizations (CMOs) focused solely on large-scale manufacturing projects. This has been true within the cell therapy CDMO market, as well as within the broader biopharmaceutical CDMO market.
Key Strategies for Positioning Cell Therapy CDMOs
The best-positioned cell therapy CDMOs tend to take one of two approaches. They either position themselves to outspend and out-build the competition (e.g. WuXi’s massive global expansion), or they compete at the opposite end of the spectrum by specializing in specific manufacturing technologies and cell types.
For example, a cell therapy CDMO may develop extensive expertise in T-cells, commonly used within immunotherapies, or mesenchymal stem cells, the most common stem cell type being explored in clinical trials worldwide. This positions cell therapy CDMOs to attract future clients based on their expertise with specific cell types.
Alternatively, a cell therapy CDMO may specialize in specific manufacturing technologies, such as closed-system bioreactors, which allows for rapid for scale-up of cell populations. Today, many cell therapies are manufactured in cleanrooms, but closed-system bioreactors will be the future of cell therapy manufacturing. Closed systems reduce risks of cross-contamination and allow simultaneous processing of multiple product batches, providing huge cost savings through facility efficiency and streamlined labor.
With lower-cost international manufacturers trying to capture a growing percentage of the market, specialization provides an effective hedge against loss of market share for smaller players within the cell therapy CDMO market.