Whether you require CGMP autologous IPSC line development and production, CGMP manufacturing for specific IPSC-derived cell types, or both, Allele’s experienced team, comprising experts in science, technology, CGMP operations, quality, and regulatory affairs, is ready to help you launch your project.
The partnership is a mutual commitment and with a shared risk. Before validating clinical safety and efficacy, your commitment is a minimal partnership commitment fee except when territory or indication exclusivities are requested, in which case a licensing fee would be required. The partnership also signifies collaborative problem-solving and Allele CDMO services are available through step-based or results-oriented billing. We will see it through together with your team.
Once you establish clinical safety and efficacy and begin planning future manufacturing, Allele’s team will provide full support for the tech transfer process, ensuring a seamless transition and effective installation. We can assist with process optimization, as well as scale-up or scale-out development, and guide you through the process till your Phase 2 meeting with the FDA.
Whether you choose to continue production at Allele Biotech in the late clinical phases or for commercial production, or if you decide to transfer the process to your facility, Allele’s team will be with you throughout the entire product development life cycle, providing unwavering support.
While autologous iPSC cell therapy has yet to become the mainstream approach in the field of iPSC-based cell therapy development, dedicated groups are forging the path forward, and Allele has always been a proud advocate among them. We play critical roles in both the upstream production of cGMP iPSC lines and the downstream cell therapy product manufacture, exemplified by our Aiβ Spheroid (Allele iPSC-derived β cell spheroid) program.
Whilst Allele CDMO supports the current iPSC industry with our Off-the-Shelf cGMP iPSC Lines and Custom cGMP iPSC Line Development services, Allele Biotech’s patented mRNA reprogramming technology, which is complete, consistent, and essentially fail-free, has made the ultimate promise of the Noble award-winning reprogramming technology–personalized regenerative medicine, a reality.
Allele stands out globally as a facility that has successfully conducted over ten years of continuous cGMP process development with a track record of not failing reprogramming for a single donor.
Allele’s mRNA reprogramming technology can be accessed for your autologous iPSC therapy through uniquely designed partnership, with the following four principles
