RUCDR Infinite Biologics Cell Culture and Stem Cell Center

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1 RUCDR Infinite Biologics Cell Culture and Stem Cell Center

2 10 MECHANICAL STORAGE (-70 C AND -80 C) CELL CULTURE LABORATORY 7 CELL LINE FREEZING/STORAGE 6 CELL LINE EXPANSION/ 4 SAMPLE ACCESSIONING MAINTENANCE 5 ENTRANCE 1 2 CELL CULTURE LABORATORY 8 STEM CELL LABORATORY 8 WALK-IN COLD STORAGE 3 SAMPLE COLLECTION KIT MANUFACTURING ROLL-UP DOOR EMERGENCY GENERATORS BULK TANK ROLL-UP DOOR 9 LIQUID NITROGEN STORAGE (-190 C) 1 Cell Culture and Stem Cell Center 2 Global Research Project Support 3 Sample Collection Kit Manufacturing 4 Sample Accessioning 5 Cell Line Initiation 6 Cell Line Expansion/Maintenance 7 Cell Line Freezing/Storage 8 Stem Cell Laboratory 9 Liquid Nitrogen Storage (-190 C) 10 Mechanical Storage (-70 C and -80 C) EMERGENCY GENERATORS

NITROGEN STORAGE (-190 C) 1 Cell Culture and Stem Cell Center 2 Global Research Project Support 3 Sample Collection Kit Manufacturing 4 Sample Accessioning 5 Cell Line

3 RUCDR Infinite Biologics Cell Culture and Stem Cell Center Welcome to the RUCDR Infinite Biologics Cell Culture and Stem Cell Center funded by grants from the National Institutes of Health, The Human Genetics Institute of New Jersey and Rutgers, The State University of New Jersey. This dedicated industrial-quality, high-volume cell culture facility is CAP-accredited and combines skilled protocol development with advanced technologies to serve the needs of biomedical researchers locally, nationally and worldwide. Our scientific partners include the National Institutes of Health and other government agencies, charitable foundations, biopharmaceutical and biotechnology companies. We hope you enjoy your tour of the RUCDR Infinite Biologics Cell Culture and Stem Cell Center! Dr. Jay A. Tischfield Chief Executive OfficeR Dr. Andrew I. Brooks Chief Operating Officer Our Mission: The mission of RUCDR Infinite Biologics is to understand the genetic causes of common, complex diseases and to discover diagnoses, treatments and, eventually, cures for these diseases. To this end, we collaborate with researchers in the public and private sectors throughout the world, providing the highest quality biobanking services and biomaterials, as well as scientific and technical support.

This dedicated industrial-quality, high-volume cell culture facility is CAP-accredited and combines skilled protocol development with advanced technologies to serve the needs of biomedical

4 1 Cell Culture and Stem Cell Center The Cell Culture and Stem Cell Center is a key-card secured, fully integrated, industrial-quality cell culture facility offering cell line production, maintenance and storage of cell-based assets. Biosafety Level II laboratory environment Largest university-based biorepository in the world College of American Pathologists (CAP) accredited Staffed 24/7/365 by trained technicians Controlled by an enterprise-level laboratory information management system (RUCDR LIMS) Continuous monitoring and documentation for facility integrity and operational performance

Biosafety Level II laboratory environment Largest university-based biorepository in the world College of American Pathologists (CAP) accredited

5 2 Global Research Project Support Comprehensive global support is provided to clients for study-specific research programs. Over 130 countries and 1,100 sites supported on six continents Personalized research project team - Ensures development and adherence to sample processing workflows - Supports sites in the collection and shipping of samples - Generates real-time reports - Follows global quality compliance standards - Guarantees project requirements are met

Over 130 countries and 1,100 sites supported on six continents Personalized research project team - Ensures

6 3 Sample Collection Kit Manufacturing Collection kits are assembled, tracked and managed based on specific study requirements and delivered to clinics, collection centers and point of care facilities. A digital archive is created for each specimen in RUCDR LIMS for chain of custody during processing, analysis and storage. Customized sample kits and protocols for the collection of biomaterials (e.g. whole blood, various organs, tissues, and externally produced cell lines) Pre-registered sample tracking to guarantee safe and timely delivery of clinical collections Comprehensive kit tracking and supply chain logistics for collection sites Customized kit instructions tailored for individual projects

Customized sample kits and protocols for the collection of biomaterials (e.g.

7 4 Sample Accessioning In-bound biomaterials are assigned sample-specific services by RUCDR global project support team. Sample tracking with full integration into RUCDR LIMS - Unique barcode identification for every collection vessel - Automated sample validation and service assignment Documentation of sample volume, quantity and type for processing

Sample tracking with full integration into RUCDR LIMS - Unique barcode identification

8 5 Cell Line Initiation Cryopreserved lymphocytes (CPLs) can be isolated and stored in our biobanks, transformed (immortalized) into lymphocyte cell lines (LCLs), reprogrammed for induced pluripotent stem cells (ipscs) or preserved for functional analysis. Separated from whole blood to establish lines Suspended in culture medium and incubated to promote growth and establishment Highest level of quality assurance/quality control ensures sample integrity Functionally tested prior to cryopreservation

9 6 Cell Line Expansion and Maintenance Cell lines are expanded to large cell numbers for DNA extraction and cryopreservation of viable stocks. Monitored and supplemented under sterile conditions by trained technicians Maintained under optimized conditions for 6-8 weeks Rigorous quality assurance/quality control - Guaranteed microbial free via QPCR mycoplasma testing - Guaranteed post-thaw viable Expanded for automated DNA extractions - Grown to 100 million viable cells for high quality genomic DNA extraction

Monitored and supplemented under sterile conditions by trained technicians Maintained under optimized conditions for 6-8 weeks

10 7 Cell Line Cryopreservation/Storage Isolation and cryopreservation of lymphocyte cells, fibroblast cells, and induced pluripotent stem cells (ipscs) in liquid nitrogen for further expansion and external distributions. Commercial-grade cell line storage utilizing heat sealed glass ampoules with 2-D barcoding Fibroblast and lymphocyte cells used for reprogramming into induced pluripotent stem cells (ipscs) Distribution of live or frozen cells Utilized for DNA and RNA expansion

Commercial-grade cell line storage utilizing heat sealed glass ampoules with 2-D barcoding Fibroblast and lymphocyte

11 8 Stem Cell Laboratory A full range of stem cell culture capabilities supports research on various disorders. Reprogramming using footprint-free methods Reprogramming of primary fibroblast or lymphocyte cells Comprehensive suite of ipsc quality control tests - Sterility, cell viability, karyotype, surface antigen expression of stem cell markers, pluripotency analysis

Reprogramming using footprint-free methods Reprogramming of primary fibroblast or lymphocyte

12 9 Liquid Nitrogen Storage (-190ºC) Liquid nitrogen (LN2) vapor and liquid phase storage of lymphoblast cells, fibroblast cells, and induced pluripotent stem cells (ipscs) and other cell-based resources. GLP/GCP compliant Secure card swipe access 24/7/365 temperature monitoring Continuous video and sound surveillance State of the art monitoring and alarm systems - Networked Robotics Tempurity system - SCADA 3000 Sensaphone system - Elpro alarm system - Automated control of LN2 levels and temperatures in tanks

GLP/GCP compliant Secure card swipe access 24/7/365 temperature monitoring Continuous video and sound surveillance State of the

13 10 Mechanical Storage (-70ºC and -80ºC) Dedicated, built-for-purpose facility houses primary -70ºC and -80ºC automated and mechanical storage. GLP/GCP processes for sample storage and management adhere to good laboratory practices (GLP) and good clinical practices (GCP) Hamilton BiOS Automated Storage System - Temperature stability for maximum sample integrity - Redundancy for sample safety - Comprehensive sample tracking - Sample picking and distribution at -80ºC Secure card swipe access 24/7/365 temperature monitoring Continuous video and sound surveillance State of the art monitoring and alarm systems - Networked Robotics Tempurity system - SCADA 3000 Sensaphone system - Elpro alarm system

Temperature stability for maximum sample integrity - Redundancy for sample safety - Comprehensive sample tracking - Sample picking and distribution at -80ºC Secure card swipe

14 Genomics Technology Center The Genomics Technology Center is a key-card secured, fully-integrated, state-of-the-art bioprocessing and bioanalytics facility. Comprised of a variety of robotic platforms serving all laboratories and multiple workflows Controlled by an enterprise-level laboratory information management system (RUCDR LIMS) Continuous monitoring and documentation of processes to ensure facility integrity and operational performance

Comprised of a variety of robotic platforms serving all laboratories and multiple workflows Controlled by an

15 An Innovative BioProcessing Solutions Alliance The Biostorage Technologies and RUCDR Infinite Biologics alliance provides to the bioscience industry an integrated, state-of-the-art scientific approach and technology infrastructure for the delivery of advanced sample bioprocessing and biobanking solutions. Sample Preparation and Extraction Services - Automated sample aliquoting and blood fractionation - Normalized biomaterial aliquoting/distribution - Tissue preparation and storage - DNA, RNA and mirna extraction Cell Culture and Stem Cell Services - Cell line establishment and processing - Tissue biopsies - Lymphoblastoid cell line creation - Stem cell line derivation and processing Genetic and Genomic Analytical Services - Gene expression profiling (low, medium, and high-throughput) - Genotyping (low, medium, high-throughput) - Next generation sequencing Bioinformatics/Analysis Services - Experimental design consulting - Data formatting and transfer - Analytical Services Biobanking Services - Mechanical: -70⁰C, -80⁰C, -20⁰C, 5⁰C - Automated: -80⁰C - Liquid Nitrogen: -190⁰C (liquid and vapor phase) - Bulk or Non-Bulk: 15⁰C - 27⁰C The benchmark in sample management

$Sample Preparation and Extraction Services - Automated sample aliquoting and blood fractionation - Normalized biomaterial aliquoting/distribution - Tissue preparation and storage - DNA, RNA and mirna$

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Comprehensive Sample Management Solutions

Comprehensive Sample Management Solutions Discover the Hidden Value in Your Sample Assets solutions consulting sample storage sample bioprocessing onsite/offsite operations management logistics/relocation