End-to-End cGMP Compliance
Our steadfast commitment to cGMP compliance encompasses every aspect, ranging from donor recruitment to the release of iPSC cell banks. We adhere to the principles of Quality by Design (QbD) as well as rigorous verification and validation processes. What we offer isn’t simply iPSCs manufactured with good notetaking or grown in a cGMP facility; we provide genuine cGMP-compliant iPSCs. For more information, read our cGMP iPSC Manufacturing page.
Highest Safety Profile
A high safety profile is achieved because of Allele’s patented mRNA reprogramming technology. It involves no nuclear events, viral elements, or any DNA molecules, guaranteeing a genome footprint-free, viral element-free outcome. This saves you from costly and time-consuming validation processes for genome integration, DNA plasmid clearance, and virus-related risks. For more information, read our mRNA Reprogramming Technology page.
Demonstrated Differentiation Potentials
The differentiation potentials have been widely validated by our industrial cell therapy development partners. They have successfully employed multiple Allele mRNA iPSC lines, differentiating them across various cell types for a wide range of disease indications. Utilizing the Allele cGMP iPSC lines can not only expedite your immediate development processes but also reduce future manufacturing time, leading to significant reductions in cost and management challenges.
Exceptional Stability
Most companies developing pluripotent stem cell (PSC)-derived therapies have struggled in to find a usable cGMP human PSC (hPSC) line for their differentiation protocol. With over a decade of pioneering experience in this field, Allele’s team can guide you through evaluations of stability which can be just as crucial as differentiation potential and safety. As off-the-shelf resources, Allele’s cGMP iPSC lines mitigate common struggles with cell maintenance and expansion, ensuring consistent long-term production success.
Rigorous Quality Control
Allele’s cGMP iPSC lines undergo comprehensive testing, including sterility, endotoxin, mycoplasma, donor/line identity, quantitation, viability, iPSC cell identity-, differentiation-, and genome integrity-related attributes. In addition, our experts are ready to assist you in all necessary details with your cell line characterization process. For more information, please refer to our cGMP iPSC Quality Control (QC) Testing page.
Continued Expansion of Off-the-Shelf cGMP iPSC Line Library
The Allele iPSC division has dedicated capacity to steadily expand its off-the-shelf cGMP iPSC line offerings. Every quarter, we initiate reprogramming of cells from two new donors and obtain three entirely independent iPSC lines from each donor. At the current pace, Allele’s cGMP iPSC line library grows by six lines every three months, which can be adjusted to align with market demand. This commitment aims to ensure that Allele provides licensees and partners with opportunities to compare multiple lines if so desired before embarking on a lengthy and costly product development journey.
Streamlining Your Path: Accessing, Testing, and Licensing
Our partner process begins with a testing phase, during which you can access Allele’s off-the-shelf cGMP iPSC line library and test multiple lines for iPSC maintenance, expansion, and differentiation based on your product’s specific design and workflow. In some cases, the licensee prefers to include additional testing in animal models to further consolidate their pre-clinical proof-of-concept results for their investors.
From there, we move forward to the development of a customized licensing agreement tailored to your specific needs. This agreement can be adapted to include exclusivity in a designated cell line, application fields or indications, and market territories. Considerations can be made in line with the preferred balance of upfront payments, milestones, and royalties.