Facility	Activities	Product/Services	Technology	Application
Milipitas, CA (Total space of 22,774 sq, ft with 8,000 sq.ft lab space)	Design, develop, manufacture, and distribute	Reference standards, iPSC, cell line, disease-specific isogenic models, cell models, animal models	CRISPR/Cas9 TARGATT™	Advance stem cell and gene-editing tools for use in biomedical research, drug discovery, bioprocessing, bioproduction and preclinical applications

Contract Research Organization (CRO) Information

	Basic Research, Disease Discovery, Drug Discovery: In Vitro & In Vivo	Preclinical Development, Bioanalysis, Bioanalytics
Purpose	Potential utilization Drug safety Chemical characterization Physical characterization	GLP Services Mouse toxicity studies Gene editing assays in vitro/ in vivo
Regulatory	Not regulated	GLP FDA 21 CFR 58
Proposal	CRO IND Enabling – GLP On-target and off-target analysis using gRNA in silico ddPCR NGS Gene editing validation in cells, including primary cells Gene editing validation in animal models Efficacy Validation In silico Guide sequence Circle sequence Rhan Sequence	CRO IND Enabling – GLP Research grade AAV production Plasmid construction and production Research grade stem cell production and gene editing

GLP

Quality System for Good Laboratory Practices (GLP) focuses on organizational process 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 device 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

GMP Facility

Applied StemCell's (ASC) GMP facility is set for iPSC generation, expansion, gene editing, and differentiation as well as general cell banking processes. ASC’s GMP facility includes manufacturing space, the storage for raw and finished products, and support lab areas. ASC’s GMP facility operates under the guidelines established by the CFR (Code of Federal Regulations) Title 21, Parts 1271 (Current Good Manufacturing for Human Cells, Tissues, and Cellular and Tissue-Based Products).

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.

Our Transgenic Animal Facility

Applied StemCell (ASC) understands that our customers require reliable, genetically-defined, transgenic animal models with specific health status and reports. We are committed to the highest quality standards in animal care and health, and we utilize state-of-the-art animal facilities in the US and China. Our facilities are designed, and expertly managed, for housing genetically modified mice and rats. All of our knockout, knock-in and transgenic animal models ship from these two locations. We are able to ship globally to any animal facility of your choice. Health monitoring records are available for review prior to shipping.

ASC-US facility is operated with veterinary oversight by the Division of Comparative Medicine; protocol review and approval by the Office of Animal Welfare Assurance; and program oversight by the Institutional Animal Care & Use Committee (IACUC). This facility is:

• Registered with the United States Department of Agriculture (USDA), Animal and Plant Inspection Service (APHIS), Animal Care (AC) as a federally approved research facility.
• Accredited through Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), holding FULL ACCREDITATION status since 1973.

ASC-China has four specific pathogen free (SPF) facilities and a space of greater than 170,000 sqft to house 60,000+ individually ventilated cages (IVC) and 300,000 SPF mice. This facility provides researchers globally with professional, comprehensive and integrated animal model services. All of our animal operations are overseen by board-certified veterinarians and the IACUC.

Both the ASC-US and ASC-China facilities offer quality and comprehensive animal model services including customized genetically engineered models (CRISPR or TARGATT™), off-the- shelf mouse lines, breeding services, phenotypic analysis, and animal in vivo assays. All services are operated under strict AAALAC standards with veterinary and IACUC oversight.

Housing, Accreditation and Staffing

Our animals are housed in a Specific Pathogen Free (SPF) facility with routine and comprehensive health monitoring. Please ask to see the list of pathogenic agents that we test for here. All animals are maintained in a combination of IVC and filtertop caging which are routinely cleaned, disinfected and sterilized. We house our animals in a facility with rigorous security and access to authorized personnel only. We use irradiated food, LabDiet 5015 for mice and LabDiet 5012 for rats, and we provide enrichment materials in every cage.

Our transgenic animal facility is staffed by quality professional technicians with extensive relevant industry experience and overseen by a laboratory animal veterinarian. The physical health of our animals is monitored every day. Any animal that appears injured or ill is referred to our veterinarian for treatment, untreatable animals are euthanized. All in-vivo work conducted strictly under AAALAC regulations.

Please contact us if you have any questions about our transgenic animal facility, health monitoring or shipment procedures.

ISO 13485

Applied StemCell, Inc., a global provider of gene editing and stem cell-based services, as well as, a leader in molecular and cellular reference standard products for clinical diagnostics markets, is proud to receive certifications for  International Organization for Standardization (ISO) Quality Management Systems (QMS) on October 31, 2017, the 13485: 2016.

The ISO certification entails extensive documentation and creation of standard operating procedures (SOP) to ensure quality services and products, customer satisfaction, continued improvement in processes, quality and workflow, and conformity to customer and regulatory requirements. The certificate approves Applied StemCell, Inc., located in Milpitas, California (USA), providing gene-editing, stem cell, and reference standard products and services for life science research, preclinical, and clinical diagnostic global markets.  In addition, we have also been awarded the ISO 13485 certification for consistently meeting customer and regulatory requirements for products and services related to medical devices, and specifically to our reference standard products.

 

Regulatory Compliance	Scope
ISO 13485:2016	Quality Management System to meet customer and regulatory requirements on the design, development, production, storage, manufacture, distribution, installation and servicing of medical device products