Applied StemCell Announces Expansion of its cGMP Manufacturing Facility to Support Cell and Gene Therapy


MILPITAS, Calif.–(BUSINESS WIRE)–Applied StemCell, Inc. (ASC), a leading cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry with their development and cell and genetic products manufacturing company, today announced the expansion of its Current Good Manufacturing Facility (cGMP). ASC has completed cell banking and product manufacturing projects in its current cGMP suite and is now ready to build 4 additional cGMP cleanrooms, cryo-storage space and process development and QC/QA space . The expansion of the facility will increase its cell banking and cellular 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 manufacturing of cell banks for safe and effective therapeutics.

“We are excited to move forward with the expansion of our cGMP facility,” said Dr. David Lee, Ph.D., GMP and Quality Manager. “Our team works closely with our customers to ensure the delivery of high quality, clinical grade products. We thank our customers for their support and trust. With the addition of 4 cGMP clean rooms, we will be able to support more researchers focused on cell and gene therapy.

President and CEO, Dr. Ruby Yanru Chen-Tsai, Ph.D. said, “We are committed to becoming a CDMO leader in supporting the development and manufacturing of regenerative medicine and cell therapy/ gene. We aim to expand our biomanufacturing capacity to meet the rapidly growing demand in the cell and gene therapy industry. Our unique GMP and TARGATT quality allogeneic iPSC platformMT Gene editing technology offers our partners great benefits, including faster manufacturing times, non-viral gene editing, and genomic stability and safety.

Construction will begin next month and the company has already begun the process of hiring staff. ASC hopes to complete the expansion and build a team that will be ready to take on up to 4 times as many new projects early next year.

About Applied StemCell, Inc.

ASC holds 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 GMP compliant protocols for cell banking and manufacturing, iPSC generation, genome editing, iPSC differentiation and product manufacturing cellular. With over 13 years of expertise in gene editing and stem cells, ASC offers comprehensive and customized cellular and genetic CRO/CDMO solutions. Its core iPSC and genome editing (CRISPR and TARGATTMT), facilitate the integration of large (up to 20 kb) site-specific transgenes and the development of allogeneic cell products.

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