Cell therapies have emerged as one of the most transformative innovations in clinical medicine today 1. Recent years have seen a rapid acceleration in the number of therapies available on the market—offering hope to countless patients.
With any new technological advancement, there are growing pains and challenges:
- Non-standardized, open processes are prone to introducing human error and contamination. Many manual touch points often lead to batch-to-batch discrepancies, manufacturing failures —and ultimately, increased costs.
- As demand for cell therapies increases, viable cell therapy manufacturing processes must be robust, reliable, and scalable. Companies need to ensure their manufacturing processes can meet the needs and market demand of the rapidly evolving cell therapy field.
- Even with regulatory bodies accelerating processes to allow for earlier approval of these potentially life-saving treatments worldwide, regulatory hurdles remain. Challenges surrounding process validation and documentation, raw material qualification, and analytical test methods pose barriers to developers.
Industry partnerships can provide critical resources and support to navigate obstacles, streamline your manufacturing process, facilitate technology adaptation, and help accelerate speed-to-market.
Cell Therapy Collaboration Program
To help overcome challenges associated with setting up cell therapy manufacturing workflows at scale, Thermo Fisher Scientific has launched a cell therapy collaboration program designed to provide support to customers on their path to clinical and commercial success.
Through our collaboration centers, cell therapy developers can leverage our expansive product and process optimization knowledge in order to create comprehensive, end-to-end manufacturing workflows that can scale for commercialization.
Learn more about the collaboration program.
Support at every stage
Key benefits of collaborating with us include:
- Gaining early access to new, state-of-the-art Thermo Fisher Scientific technologies including media and reagents, instrumentation, analytical solutions, and laboratory equipment—sometimes well before they’re available to a wider market. This includes our series of closed, modular, and automated instruments specifically designed for cell therapy applications.
- Receiving support for manufacturing protocol and process optimization from our highly specialized team of scientists and engineers. Our dedicated teams assist in implementing our broad range of fit-for-purpose instrumentation, assays, and tools into your workflows to help meet cell therapy manufacturing requirements and achieve your unique goals.
- Helping facilitate a seamless transition to the clinic with the high degree of supporting product qualification and the traceability documentation provided alongside our range of cell therapy-specific products.
- Obtaining ongoing support as cell therapy programs grow and advance—as new needs arise, our teams remain readily available to discuss and answer questions as well as to provide platform-specific troubleshooting of technical issues.
Collaborate with us
Connect with our knowledge and experience in complete cell therapy manufacturing solutions. To get started, fill out the form found here.
Sources
- Mount NM, Ward SJ, Kefalas P, Hyllner J. Cell-based therapy technology classifications and translational challenges. Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19;370(1680):20150017. doi: 10.1098/rstb.2015.0017. PMID: 26416686; PMCID: PMC4634004.