ASC Headquarters           
Milpitas, CA
(Total space of 15,000 sq. ft. & 10,000 sq. ft. of lab space)

Contract Research Organization (CRO/CDMO) Information

Facility:

1. Cell culture rooms: three large (~650-750 sf each) and two small (~250 sf each); They are equipped with biosafety cabinets (2 in the small room, and 5 in each of the big rooms), electroporation systems, CO2 incubators, centrifuges, water baths, fluorescence microscopes and FACS machine necessary for cell culture needs. High-throughput automation system for gene editing includes imaging system, Hamilton liquid handler/colony picker.
2. Molecular biology laboratory: three labs (1500 sf, 780 sf, and 790 sf) and 30 benches dedicated to molecular biology work; The laboratories have all necessary equipment including NGS, ddPCR, qPCR, gradient PCR machines, electroporators, centrifuges, gel electrophoresis apparatus, gel imaging system, water baths, shakers, freezers, refrigerators, water purification system, a spectrophotometer, and others.

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).

Licensed Drug Manufacturing Facility

Applied StemCell (ASC) has been issued a drug manufacturing license by the California Department of Public Health. ASC's headquarters includes a manufacturing space that is in compliance with the provisions of Division 104, Chapter 6, Article 6 California Health and Safety Code.

GLP (FDA 21 CFR 58)

Quality System for Good Laboratory Practices (GLP) focuses on organizational processes and conditions under which non-clinical health and environment safety studies are planned, performed, monitored, recorded, archived, and reported.

Non-clinical lab studies that supported or are intended to support application(s) for research or marketing permits for the following products:

• Human and animal drugs
• Medical devices for human use
• Biological products

Document Control

• QA review of SOP, protocol, study report for GLP compliance
• Written protocol contains objective, methods, test article, test system, nature of study, date of study, current status, sponsor, study director
• QA inspection records (interval)
• History file archives will be kept for 5 years
• Archives will be audited by FDA
• Facility control
• Lab operation
• Animal care
• Equipment notebook, calibration, maintenance
• SOP
• Reagent
• Storage

Test & Control Article

• Characterization
• Identity, strength, purity, stability, uniformity
• Handling
• Storage

ISO 13485

Applied StemCell, a global provider of gene editing and stem cell-based services, is proud to have received certification for International Organization for Standardization (ISO) Quality Management Systems (QMS) 13485: 2016 on October 31, 2017.

The ISO certification entails extensive documentation and creation of standard operating procedures (SOP) to ensure quality services and products, customer satisfaction, continuous improvement in processes, quality and workflow, and conformity to customer and regulatory requirements. The certificate approves Applied StemCell, Inc., located in Milpitas, California (USA), as a provider of gene-editing, stem cell, and reference standard products and services for life science research, preclinical, clinical, and diagnostic global markets. 

Animal Facilities:

US Animal facility:  The animal care and use operations of Applied StemCell is located in facilities operated by the OUHSC (Oklahoma University Health and Science Center); with veterinary oversight by the OUHSC Division of Comparative Medicine; protocol review and approval by the OUHSC Office of Animal Welfare Assurance; and program oversight by the OUHSC Institutional Animal Care & Use Committee (IACUC). The facility is (1) registered with the United States Department of Agriculture (USDA), Animal and Plant Inspection Service (APHIS), Animal Care (AC) as a federally approved research facility; (2) assured through the NIH Office of Laboratory Animal Welfare (OLAW); (3) accredited through AAALAC, holding FULL ACCREDITATION status since 1973.

China Animal facility:

ASC-China has four specific pathogen-free (SPF) facilities and space of greater than 170,000 sq. ft. to house 60,000+ individually ventilated cages (IVC) and 300,000 SPF mice. All of our animal operations are overseen by board-certified veterinarians and the IACUC. This facility is AAALAC accredited and OLAW assured.

ASC Offerings

Design, develop, manufacture, and distribute:

• iPSC reprogramming, gene editing, and differentiation
• GMP grade iPSC line with drug master file at US FDA
• Universal modifiable iPSC platform for an unlimited source of therapeutic cells
• NIST standard gene edited iPSC lines and genomic DNA
• Reporter cell line generation
• Cell-based assays in iPSC-differentiated cells
• TARGATT™ master iPSC lines for guaranteed, safe, and stable protein expression
• Antibody discovery libraries and bioproduction (CHO, HEK293)
• Knock-out, point Mutation, knock-in in vivo/in vitro, and humanized models
• Customized IND enabling preclinical and early Clinical CRO services (in vitro/in vivo)
• Biodistribution, toxicity studies
• R&D, POC studies
• Assay development
• Drug efficacy validation
• Human reconstitution animal models (CD34+/PBMC models)
• Bioanalysis, gene editing validation (DNA, RNA, Protein)
• Phenotype analysis/drug screening
• Cell expansion/banking/storage, custom manufacture (GMP)
• Primary cell procurement
• Document control
• QA review of SOP
• Batch test & control Article
• Technical Transfer
• Consultation

Technology

• TARGATT™
• CRISPR/Cas9
• iPSCs/Stem Cells
• TARGATT^TM iPSC-iNK Platform

Applications

• Advanced stem cells (iPSC) and gene-editing tools for research, drug discovery, antibody discovery, bioproduction, regenerative medicine, and preclinical/clinical applications
• Allogeneic off-the-shelf master lines for cell therapy development
• GMP biobanking