Applied StemCell expands manufacturing facility to support cell and gene therapies
The Milpitas, California cell and gene therapy CRO/CDMO, whose focus is on supporting the research community and biotechnology industry in developing and manufacturing cell and gene products, has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, and a process development and QC/QA space.
The expansion of the facility will increase its cell banking and cell product manufacturing capacity and allow ASC’s team of experts to work simultaneously on multiple manufacturing projects such as iPSC generation, gene editing, differentiation, and cell bank manufacturing for safe and efficacious therapeutic products.
ASC estimates it will be able to take on four times as many projects once the expansion is complete early next year. Work on construction will begin within the next month and the company has already started the process to hire new staff.
President and CEO, Dr. Ruby Yanru Chen-Tsai, Ph.D. said, “We are committed to becoming a CDMO leader to support regenerative medicine and cell/gene therapy development and manufacturing. We aim to expand our bio-manufacturing capacity to meet the fast-growing demand in the cell and gene therapy industry.
"Our unique platform of GMP-grade allogeneic iPSC and TARGATT gene editing technology provides our partners great advantages, including shorter manufacturing timelines, non-viral gene editing, and genomic stability and safety.”
ASC has a Drug Manufacturing License from the California Department of Public Health, Food and Drug Branch (FDB). It has a Quality Management System (ISO 13485 certified) and established cGMP-compliant protocols for cell banking and manufacturing, iPSC generation, genome editing, iPSC differentiation, and cell product manufacturing.
With over 13 years of gene-editing and stem cell expertise, ASC offers customized cell and gene CRO/CDMO solutions. Its core iPSC and genome editing (CRISPR and TARGATT) technologies, facilitate site-specific, large cargo (up to 20kb) transgene integration and the development of allogenic cell products.