The High Cost Of Going Cheap
By Jessica Carmen, PhD, Kincell Bio
In the world of drug development, particularly in cell and gene therapy, costs can quickly spiral out of control. To combat this, drug developers often seek ways to cut expenses during the early stages of product development. One potential area for cost-cutting is the use of research-use only (RUO) leukopaks instead of the more expensive current Good Manufacturing Practice (cGMP)-grade leukopaks. By opting for RUO leukopaks, developers can save substantial amounts of money without compromising the scientific rigor of their research.
However, when it comes to viral vector manufacturing, cheaper alternatives like RUO or "home grown" batches can present significant challenges. These cost-effective preparations often contain impurities that can negatively impact the efficacy and potency of the final product. Using impure vectors can lead to failures in the production process, resulting in delays and additional costs for the development and manufacturing teams.
As a result, developers are left with expensive and risky options, such as proceeding with a wider aperture on analytical methods or delaying IND filing and investing in further development work. While cost-cutting measures like using RUO leukopaks can be advantageous, investing in high-quality GMP-grade vectors can ensure the long-term successful development of engineered cell therapies. Cutting corners in this area can lead to significant setbacks and hinder the overall progress of drug development.
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