After three years of cleanroom construction and two years of quality system establishment, Allele Biotech has produced its initial batch of six iPSCs (induced pluripotent stem cells) lines that are ready for prime time.
Headquartered in San Diego, California (US), Allele Biotech specialises in biological processes to develop technologies and products for biomedical research and therapy development.
Prior to Allele’s cGMP iPSC generation, there were only a handful of GMP iPSC lines available for therapy development from other sources around the world, forcing pluripotency inspired companies to resort to embryonic stem cells (ESCs) as their starting material.
ESC lines have many limitations due to questions of whether they were created with consent that meets today's standards, and whether there have been gaps in custody throughout their history of existence.
Donor consent and cGMP monitoring
Allele’s iPSCs were created using its patented mRNA technologies, with full cGMP monitoring and documentation starting from donor consent, screening and tissue biopsy.
The company's San Diego facility received California tissue bank license earlier this year, and there, Allele’s dedicated stem cell manufacturing team first produced dozens of banked fibroblast stocks that are fully cGMP-compliant.
Allele newly built cleanroom. Photo by Allele Biotech
The team is now churning out iPSC lines at an unprecedented pace. Even though it takes just 1-2 weeks to reprogramme fibroblasts into iPSCs using the mRNA method, production of cGMP-compliant iPSCs takes 3-4 months due to the stringent testing and quality control assays Allele painstakingly developed and qualified.
In addition to iPSC generation and differentiation, Allele said its proprietary mRNA platform can be used to engineer human iPSCs in a one-time genetic modification event to generate a clonal iPSC line that can be developed into a master cell bank.
Allele has received notification that patents have been allowed in EU and Japan one month after receiving two US patents on generating mRNA-iPSCs.
mRNA produced iPSCs are more stable and easier to differentiate as Allele has previously reported, and their manufacturing process is continually being improved and upgraded.
Focusing on industrial use of iPSCs, Allele said it has established a suspension iPSC culture system that can generate billions of iPS cells in a closed system before induction to differentiation.