Within the last year, progress in cellular therapies have led to the restoration of eyesight, construction of new skin, a cure for sickle-cell, and the FDA approval of cancer-killing CAR-T cells, and it’s set to advance even further. However, these types of therapies can be hindered by the cost and time to develop. With some taking over 7 years and $2.5 billion to find their way to the FDA approval process, these new therapies may not feasible for those in need. As you might imagine, this price tag only becomes steeper with setbacks along the developmental and manufacturing process, which can not only incur costs but also delay the time to market and to the hands of the patient.
To increase efficiency and drive down costs while maintaining or improving the quality of the product, FDA regulators have defined the “product as the process” and, therefore, the process must be well characterized, well controlled, and well documented. And this paradigm shift has been catching traction within the biopharmaceutical industry.
The increasing level of regulation can be eased through the use of well-defined raw materials and methods that meet current Good Manufacturing Practices (cGMP). GMP-quality products are ideal for a wide range of cellular therapy studies in laboratories looking to facilitate a smooth transition from bench and animal research to downstream clinical applications. Subsequently, both regenerative medicine researchers and clinicians are now looking for GMP-quality products with a smoother regulatory approval process as the goal, which helps eliminate costly and time-consuming bridging studies.
How StemExpress can support your process.
StemExpress’ Clinical Grade Non-Transfusable products adhere to the same regulations as clinical grade products regarding GMP guidelines, documented training, QA issued production records, dedicated production site preparation, testing and release of raw materials, dedicated supplies, and validated cleaning methods. These high-quality products ensure the integrity and clinical relevance of the data being collected by eliminating irreproducible results and misinterpretation of the data in the research and preclinical stages of development, which can lead to failure of clinical outcomes and setbacks to market launches.
Clinical Grade Non-Transfusable products
The Bottom Line
By providing a consistently high-quality, readily available commercial source of cell products that comply with FDA regulations, StemExpress helps researchers accelerate their manufacturing, scale-up production, and shorten developmental timelines to quicken the time to market and the availability for patient use.
Get in touch with us to discuss your needs and see how we can support your project.