Applied StemCell  

http://www.appliedstemcell.com

ASC is a leading gene editing & stem cell therapy CRO/CDMO.

Applied StemCell, Inc. (ASC) is a leading gene editing and stem cell therapy CRO/CDMO company. We support gene editing and stem cell therapy innovation with two high-impact platforms: CRISPR/TARGATT™ genome editing and iPSC (GMP grade) and high-quality manufacturing services.

As a CRO/CDMO, ASC offers a complete iPSC service and product platform to support researchers globally. Our new cGMP CMC facility in Milpitas, California, is fully equipped to support GMP gene-editing and cell manufacturing projects. 

• GMP iPSC/MSC Derived Cell Manufacturing
• GMP iPSC Gene Editing and Differentiation (Microglia, NK Cells & More)
• Pre-clinical/CRO Services

ASC’s proprietary TARGATT™ technology enables site-specific, stable integration of large DNA fragments into a safe harbor locus more efficiently (~10x better than CRISPR) and faster, with guaranteed transgene expression without the disruption of internal genes and gene silencing. ASC’s TARGATT™ master iPSC line provides an unlimited source of cells of any kind containing therapeutic genes. Application of ASC’s TARGATT™ master iPSC line includes the development of off-the-shelf CAR-iNK/CAR-iT products.

Brands: ASC is a leading gene editing & cell therapy CRO/CDMO with its cGMP facility located in the CA. Learn more about our GMP-grade iPSCs & cell drug manufacturing capabilities for your pipelines.

 Show Specials

• GMP Facility Tour/New GMP-Like Services (Feb 28, 2023)

  Current GMP Facility:

  The facility operates under the guidelines established by the Title 21CFR (Code of Federal Regulations) Part 1271 (Current Good Manufacturing for Cells, Tissues, and Cellular and Tissue-Based Products). The facility includes a GMP suite of about 1200 sq. ft. to Class 10,000 cleanroom, with HEPA filters, airflow, passing-through window, gowning room, new floor, etc. that are all in compliance with FDA 21 CFR 210, 211, 1271, FDA cGMP, and GTP standards. The GMP room is fully equipped for cell manufacturing and gene editing work. Other supporting spaces include a dedicated raw material room (~150 sf), process development space, QC/QA space (~5000 sf), and storage space (~300 sf).

  GMP Facility Expansion:

  Applied StemCell has entered the GMP manufacturing space offering an assortment of reliable and efficient service options but seeks to continue to grow with the expansion of our GMP facility, set to open later this year. If you would like to join us for the grand opening and an exclusive tour of the new facility contact us today.

  New GMP-Like Plasmid Service:

  With a complete GMP-like plasmid DNA development platform, ASC's team of experts can design and optimize your vector, provide expansion and banking services (working and master cell banks), and perform comprehensive QC checks prior to product delivery. If you would like to learn more, contact us today.

 Press Releases

• ASC Announces the Expansion of its cGMP Manufacturing Facility to Support Cell and Gene Therapy | ASC (Feb 17, 2023)
  Milpitas, California, August 29, 2022 -- Applied StemCell, Inc. (ASC), a leading cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry for their needs in developing and manufacturing cell and gene products, today announced the expansion of its Current Good Manufacturing (cGMP) facility. ASC 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.

  “We are very excited to move forward with the expansion of our cGMP facility,” said Dr. David Lee, Ph.D., Head of GMP and Quality. “Our team has been working closely with our clients to ensure delivery of high-quality clinical grade products. We thank our customers for their support and trust. With the addition of 4 cGMP cleanrooms, we will be able to assist a greater number of researchers focused on cell and gene therapy.”

  President and CEO, Dr. Ruby Yanru Chen-Tsai, Ph.D. stated, “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 TARGATTTM gene editing technology provides our partners great advantages, including shorter manufacturing timelines, non-viral gene editing, and genomic stability and safety.”

  Construction will begin within the next month, and the company has already begun the staff hiring process. ASC hopes to have the expansion completed and a team built that will be ready to take on as much as 4 times more new projects early next year.

  About Applied StemCell, Inc.

  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 comprehensive and customized cell and gene CRO/CDMO solutions. Its core iPSC and genome editing (CRISPR and TARGATTTM) technologies, facilitate site-specific, large cargo (up to 20kb) transgene integration and the development of allogenic cell products.

 Products