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

Our Transgenic Animal Facility

Applied StemCell 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 a state-of-the-art animal facility in the San Francisco Bay Area, California. Our facility is designed, and expertly managed, for housing genetically modified mice and rats. All of our knockout, knock-in and transgenic animal models ship from this location. We are able to ship globally to any animal facility of your choice. Health monitoring records are available for review prior to shipping.

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.

We partner with Vium for animal care. There are 2 procedure rooms and 4 animal holding rooms. All work is under the independent oversight of the Institutional Animal Care and Use Committee (IACUC), as mandated by the Animal Welfare Act of 1966 and the following amendments (7 USC, 2131 – 2159). The environmental controls conform to engineering standards set forth in the 8^th Edition of the Guide for Care and Us of Laboratory Animals http://dels.nas.edu/Report/Guide-Care/12910

We are committed to animal welfare and to consistent, genetically correct and reliable research animal models. Our facility is accredited by AAALAC, the PHS and OLAW assurances. AAALAC accreditation assures that all work conforms to US regulation and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, Council of Europe.

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.

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

ISO 9001, 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 two International Organization for Standardization (ISO) Quality Management Systems (QMS) on October 20, 2017, the ISO 9001:2015 and 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 requirement on the design, development, production, storage, manufacture, distribution, installation and servicing of medical device products
ISO 9001:2015	Quality Management System to improve customer satisfaction, increase process efficiency, identify risk, continuous improvement, evidence-based decision making