CDMO: An Approach for Scalability and Manufacturing
Over the last few decades, cell therapies, such as stem cell and CAR-T, have become increasingly important in fighting cancer and are therefore creating a need for cell therapy companies to make these life-saving products available at a larger scale. Cell therapies have become personal, that is they can be tailor made to be an exact fit for an individual and that individual’s cancer. Personalized medicine is the wave of the future in healthcare.
What is a CDMO?
A Contract Development and Manufacturing Organization (CDMO) is a company that provides development and manufacturing services on a large scale. For example, when a pharmaceutical company needs to develop and manufacture a drug quickly, efficiently and at a lower cost, they enlist the help of a CDMO. This is not to be confused with a Contract Manufacturing Organization (CMO), which in this case, takes a pre-formulated drug and scales up the manufacture of it.
Biotechnology, Pharmaceutical and Biopharmaceutical companies all develop and manufacture medicines, but they do so in very different ways. A pharmaceutical company (pharma) makes medicines derived from chemicals while a biopharmaceutical company (biopharma) may also utilize living organisms, such as yeast or bacteria, in their manufacturing process. For example, a bacterium may be genetically altered to overproduce and secrete a specific drug or compound in a bioreactor which is then isolated and formulated for distribution. Biosynthetic “human” insulin was the first product to be manufactured in this manner by Genentech and later marketed in 1982 by Eli Lilly and Company.
So, the main difference between pharma and biopharma is in the way the drug is manufactured, that is from a chemical or using a living organism. Biotechnology companies (Biotech) add yet another level of technology to the mix by utilizing living cells or cell materials for use in medical treatments known as cell and gene therapies. Examples are Hematopoietic and Mesenchymal Stem Cell (HSC and MSC respectively) as well as CAR-T and CAR-NK cell therapies.
Contract manufacturing companies focused on the development of cell and gene therapies are the new kids on the block. Leveraging what they have learned from pharma and biopharma about scaling up manufacturing processes, Biotech’s are gearing up to marry these processes with cell and gene processing technologies to form a perfect union in order to manufacture the next generation of medicines, cell and gene therapies.
What to Consider when Choosing a Cell Therapy CDMO
When selecting a cell therapy CDMO partner, companies should consider several factors, including:
Process expertise and efficiency
Scientific expertise
Manufacturing capacity
Regulatory expertise
Process security
Cost effectiveness
Transparency
Most importantly, cell and gene therapy companies should partner with a CDMO that both aligns with the vision they have for their product and also has the company’s best interest at heart. A good partnership is one that fits the needs of the company and aligns with the resources and abilities of the CDMO.
Benefits of Using a Cell Therapy CDMO
Cell and gene therapies offer great opportunities to the many companies developing them as well as the patients who need them but there are numerous challenges associated with development and manufacturing of these therapies that put their future at risk. Smaller biotech companies cannot afford the sizable costs the scale-up to manufacture requires. Even larger companies, who may have the working capital to undertake such a project, find the costs as well as the logistics overwhelming. Therefore many cell and gene therapy biotech’s are turning to CDMOs for cell manufacturing, as there are many benefits.
Scalability
For cell manufacturing companies, shifts in production volume or the addition of new variances can be risky. An experienced contract manufacturer has space available that is equipped and ready for production. They also have the ability to downsize if needed. A CDMO partnership can help companies reduce their risk by helping them scale their production up or down as needed, reducing the time and money needed to bring these therapies to market.
Speed to Market
The cell and gene therapy product development process, as regulated by the FDA, includes many steps, which can take small companies a long time to work through. By outsourcing development and manufacturing to a CDMO, companies of all sizes can bring their products to market with greater efficiency.
Regulatory Support
A CDMO can help a cell therapy company ensure that it is meeting regulatory requirements set forth by the FDA. A good partner will not only communicate with regulators but ensure that your submission is on track for approval throughout the review process.
Technical Support
The rapid rate of innovation within the technology sector will continually lead to obsolescence of manufacturing processes making production of cell therapies even more reliant on the science overseeing it. The expertise and experience that a company can find in a full-service CDMO is invaluable. The manufacturing of a product requires a great deal of technical support available through partnership.
Cost Effectiveness
One of the greatest benefits of a CDMO partnership is the reduction in cost. Cell and gene therapy companies need to ensure that they are fully evaluating the production process to ensure efficiency. While it’s relatively easy to define labor costs associated with production, overhead costs are often overlooked and/or difficult to calculate. Careful selection of a CDMO partner can eliminate many of the hidden overhead costs as well as unnecessary spending, and also increase the efficiency of production, which inevitably results in financial savings as well.
The Importance of Automated Closed Systems in the Cell Manufacturing Process
In order for cell therapies to be safe and effective, they must be manufactured with the utmost care. While traditional cell processing is conducted in a laboratory setting as an open system, it is much more efficient, safe, and cost effective to use an automated closed processing system with state-of-the-art technology such as the CAR-TXpress Platform.
The benefits of using a automated closed system include:
Reduced risk of contamination – closed systems provide a physical barrier to prevent contaminants from affecting the product.
Reduced process time – these systems rely less on operator handling, and many, such as the CAR-TXpress, are fully automated.
Greater cost effectiveness – the reduced reliance on operator handling and the automation of closed systems results in a reduction in the cost of production.
How ThermoGenesis’ Products Can Streamline the Cell Manufacturing Process
With revolutionary cell-based therapies, such as CAR-T (chimeric antigen receptor T-cell) for cancer becoming a reality, developers must address a key challenge: how to manufacture high-quality, clinical-grade cell therapies at commercial scale to provide these groundbreaking treatments to as many patients as possible.
ThermoGenesis Holdings is transforming cell therapy manufacturing with the CAR-TXpress™ Platform designed to automate many of the manual steps involved in cell processing. This platform is a multi-system package, equipped to provide a streamlined solution for cell processing, cell selection, washing and cryopreservation. The CAR-TXpress Platform can provide a comprehensive and commercially viable, semi-automated cellular manufacturing and control (CMC) solution for the development of CAR-T and CAR-NK therapeutics.
CAR-TXpress eliminates the use of density gradient media for isolation and replaces magnetic bead-based systems used for selection procedures, thereby dramatically reducing processing time and increasing cell recoveries, in order to significantly reduce the overall manufacturing time and cost and increase the yield/efficiency of high value samples.
For more information on the CAR-TXpress multi-system platform, please contact us.
