For biotechs seeking to develop novel therapeutics for conditions like Parkinson’s disease, diabetes, and cancer, the development of a relevant cell model for use in preclinical research and development phases is imperative. And regardless of whether your research calls for adherent cells or the more in vivo–like 3D organoids, cell culture will remain an important part of your process as you scale.
With the right cell model, early-stage discovery is streamlined. But how do you ensure that your cell model performs the way you need and expect it to during transition from research to development? The right cell culture media can certainly help, and as many researchers have experienced, there is no such thing as a one-size-fits-all medium. Every cell model has unique requirements.
The ideal cell culture medium for therapeutic research and development should:
Each of these metrics in turn is affected by the composition of the basal medium (i.e., the identity of the salts, buffers, and growth supplements like vitamins and amino acids), the pH (i.e., atmospheric CO2 levels, which can be buffered using sodium bicarbonate in the medium), and any media supplements such as growth factors, cytokines, and chemokines required by the cell type, antibiotics, and proteins .
Learn more aboutour small-scale media customization services
There are many parts of your therapeutic development operation that require continual evaluation as you scale, and your media formulation is no exception.
As you move your cell culture from a smaller volume (e.g., a flask) to a larger volume (e.g., rocker bag, bioreactor), the optimal cadence and timing of media exchanges can differ, which can affect the ratio of media components such as salts, proteins, and growth factors. Ratios that are ideal in a small vessel may not be so in a large bioreactor.
Then, as you approach clinical trials, you’ll need to exchange undefined media additives like fetal bovine serum (FBS) for chemically defined, animal origin–free, or xeno-free alternatives in order to be compliant with the appropriate regulatory agencies. Many therapeutics manufacturers choose chemically defined media at the outset for this reason, and due to the contribution of serum to the overall cost at scale. Since therapeutics are highly regulated, it’s also important to ensure that the manufacturer of the medium adheres to good manufacturing practices (GMP) and can assure supply as you scale.
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In addition to ensuring that your media formulation caters to the basic needs of your cell model and contains raw materials that will enable you to scale quickly, custom media services offer the following benefits:
Gibco Media Express services
|Harmonized raw materials||cGMP-qualified raw materials|
|Research Use Only (RUO)||RUO and other Intended Use options available|
|Batch volumes||Batch volumes|
Standard packaging available
Standard and custom packaging options available
Limited testing available for a fee
Results provided without a CoA.
Price includes the following tests:
Additional tests available. Results provided with a CoA.
|Production lead times|
Typically 2 to 3 weeks for liquid and powder medium
|Production lead times|
Lead times vary based on request
Figure 2. Gibco custom media services use harmonized raw materials regardless of scale. Customize as little as 1 L liquid medium, or up to 10,000 L.
A clinical-stage biopharma company was looking to improve manufacture of their CAR T cell therapy product.
Thermo Fisher Scientific provided fully defined serum-free formulations manufactured according to GMP. With these solutions, the biopharma company achieved their target expansion with minimal risk. The custom media and supplements are now used in their commercial cell therapy manufacturing process.
A large biopharma company was scaling up for production of novel cell-based therapeutics for unmet medical needs.
Thermo Fisher Scientific invested in a new, state-of-the-art aseptic manufacturing facility in Vilnius, Lithuania, to help meet quality and scale standards; partnered with the customer to manage risk and meet regulatory standards worldwide; and increased manufacturing capacity 2.5-fold at the new site to meet demand.
By partnering to develop best-in-class technologies at the new facility and manage risks, the novel therapeutic was in compliance with varied worldwide regulatory standards and security of supply was provided. The biopharma met demand for up to 50,000 patients per year and reduced their costs by limiting the number of suppliers and decreasing the number of lots per year.
Partner with us today to develop your unique products through customization to fit your precise specification and workflow needs.
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For Research Use Only. Not for use in diagnostic procedures.