Allele Biotechnology and Pharmaceuticals forming GMP cell biobank business for personalized medicine
San Diego-based Allele Biotechnology and Pharmaceuticals (CA, USA) has announced plans to create a GMP-compliant human iPSC biobank for private individuals seeking personalized medicines
Allele Biotechnology and Pharmaceuticals, Inc., has announced plans announced plans to form a commercial iPSC biobanking business for individuals seeking personalized therapies. The business will be guided by renowned Drs Mahendra Rao and Joseph Paulauskis, and will be cGMP compliant. The biobank will mean that individuals will have their own cells stored ready for whenever they might need to use them, for example to repair or regenerate a diseased or damaged tissue or organ.
In addition to serving its clients, the iPSC lines and accompanying sequence database and health information to be made available from the bank to scientists and clinicians – a great resource for biomedical research.
“We are happy to have the guidance from world leading experts in stem cells, biobanking, and cell therapy fields such as Drs. Rao and Paulauskis”, stated Jiwu Wang PhD, President and CEO of Allele. “We believe that setting the bar high will be ultimately beneficial to future customers, fellow researchers, industry partners, and regulatory agencies alike. We are happy to see the recent release by the International Society for Stem Cell Research of a draft of ‘Guidelines for the Clinical Translation of Stem Cells’, whose principals we plan to follow closely. We also intend to obtain certification by the cord blood banking association AABB, if possible, and abide by other regulatory rules as they become public, such as the "Stem Cell Clinical Research Management (tentative)" by the Health Commission of China, if and when we move to operate under that jurisdiction”.
Allele recently acquired a new facility that will generate the cells, via Allele’s proprietary synthetic mRNA platform – a technology that generates ‘footprint-free’ cells optimized for therapeutic use. Their technology has been licensed for clinical trials by companies such as Ocata Therapeutics (formerly ACT).
The availability of the hiPSCs and the associated in-depth data to researchers will be a valuable resource for the biomedical community, especially for regenerative medicine. The more cell lines and data made available to researchers, the more progress we will make in better understanding and finding therapies for patients in need.