COMPREHENSIVE TESTING SOLUTIONS
INTRODUCING BIOBRIDGE GLOBAL
Blood & Tissue Banking
BioBridge Global is a San Antonio-based nonprofit organization. Through its subsidiaries, it offers products in blood and tissue banking, comprehensive testing capabilities and a broad range of services supporting the development of advanced therapies.
Donor Screening, Microbiology, Environmental Monitoring Starting Materials, Testing, Biomanufacturing
Mission Statement:
To save and enhance lives through the healing power of human cells and tissue.
QUALTEX LABORATORIES: A SUBSIDIARY
OF BIOBRIDGE GLOBAL
QualTex is the second largest independent nonprofit testing laboratory in the United States. It provides state-of-the-art, automated high-volume capacity donor screening and biological testing services, with locations in San Antonio and Atlanta.
• 6 million donations tested annually
• 40 million test reports annually
• 100+ assays performed on site • 24/7/365 customer service
• Custom assay development • 54,000 sq. ft. of laboratory space
QualTex, San Antonio
QualTex, Atlanta
HIGH-QUALITY TESTING SOLUTIONS
Donor Screening
Microbiology
Research & Development
Servicing:
• Biotech and Pharma
• Blood Centers
• CDMOs
• Medical Device Manufacturers
• OPOs
• Plasma Fractionators
• Researchers and CROs
• Tissue and Eye Banks
• Tissue Processors
STATE-OF-THE-ART TESTING SERVICES
Donor Screening
• Blood group & typing
• Serology
• Nucleic Acid Testing (NAT) For
• Whole blood
• Source plasma
• Recovered plasma
• Cadaveric tissue donors
• Living donors
• Heart-beating organ donors
• Reagent donors
• Starting material donors
Microbiology
• Sterility
• Bioburden
• Recovery testing
• Microbial identification
• Microbial qualification
• Growth promotion
• Testing for Aseptic Process Simulation (APS)
• Environmental monitoring
• Endotoxin LAL
• PCR-based Mycoplasma
• Residual moisture
Research & Development
• Custom assay development
• Lot and final product release testing
• Clinical trial support for FDA assay submission
• Data generation for regulatory submission of assays and equipment
Other Testing Services: biological raw material infectious disease testing, test method suitability, production pool testing
WHY CHOOSE QUALTEX?
AUTOMATION & TECHNOLOGY CAPABILITIES
QualTex worked in partnership with Abbott to implement a state-of-the-art ACCELERATOR® a3600 Laboratory Automation System, doubling testing capacity in Atlanta and San Antonio.
• ACCELERATOR® a3600 Laboratory Automation System
Sample processing, testing, storage ALINITY testing instruments
• GLP systems Track - Advanced automation system for source plasma testing
• Proprietary customer ordering portal
• Instrument Manager - 510(k) middleware
• STARLIMS® - Robust, flexible lab information system
• Kaleidoscope - MDDS registered proprietary software allowing for customization of testing algorithms and result formats per individual client needs
EFFICIENCY THROUGH AUTOMATION
Allows for Rapid Turnaround Time
• Flexible capacity
High-volume throughput
Surge readiness
Platform redundancy
• Real-time result delivery
• Automated monitoring from pending testing to completion
• In-process QA review and automated FDA requirement adherence
BROAD QUALITY AND REGULATORY COMPLIANCE
• Integrated Quality Management System (QMS)
• SOP and documentation development
• Regulatory filing support
• Document control
• Internal/external audits & inspections
• Process monitoring against 6σ
Compliance with US and International Agencies
10 Regulatory/ standard body inspections per year ~
30 Customer inspections per year ~
17Days ~ Robust quality event management Average event age at closure
EQUIPPED TO MANAGE LOGISTICAL VARIABILITY
Validated Domestic and International Shipping Processes across 4 Continents
• 100,000+ global shipments annually
• Temperature-controlled shipments
• Shipping from two major airports: San Antonio, TX & Atlanta, GA
APPENDIX
WHOLE BLOOD TESTING
Comprehensive Testing
• Donor screening, supplemental, and confirmatory testing
• On-site Immunohematology Reference Laboratory (IRL)
Automation
• ACCELERATOR® a3600 Laboratory Automation System manages a high sample volume, while ensuring consistent testing and reduction in contamination and failure risk
• Real-time sample visibility and quality monitoring using Starlims®
• Operational continuity and surge capacity through integrated platform redundancy
• Seamless integration for all BECS
Turnaround Time*
• Infectious disease: 10–12 hours average
• IRL: 48 hours average
QualTex provides contingency testing for blood centers during operational disruptions or surges
*Turnaround times customizable based on client requirements. All TATs are from sample receipt.
ACCELERATOR® a3600 Laboratory Automation System
SOURCE PLASMA TESTING
Comprehensive Testing
• Donor screening, supplemental, and confirmatory testing
• Drug Product QC and Production Pool QC
• Customized testing and specialized program support for plasma fractionators
Automation
• ACCELERATOR® a3600 Laboratory Automation System manages a high sample volume, while ensuring consistent testing and reduction in contamination and failure risk
• GLP systems Track instrumentation enables single-tube testing for multiple assays with scalable pre-analytics
• Real-time sample visibility and quality monitoring using Starlims®
• Operational continuity and surge capacity through integrated platform redundancy
• Streamlined ordering through AcQuire electronic portal or DMS integration
Turnaround Time*
• 3-5 days average
*Turnaround times customizable based on client requirements. All TATs are from sample receipt.
GLP systems Track
TRANSFORMING LABORATORY AUTOMATION
ACCELERATOR®a3600 Laboratory Automation System
Optimizes blood testing and laboratory workflows through automation technology.
• Increased testing capacity across facilities by 2x
• Increased average samples tested per shift from 5k to 6.3k
• Number of touchpoints per sample reduced from 7 to 3
GLP systems Track
Adaptive, high-throughput, and robust automation platform for source plasma testing.
• Provides single-sample testing capability
• No serum tube needed
• Accelerates turnaround times, delivering fast results
DONOR SCREENING - HCT/P
Comprehensive Testing
• Donor screening, supplemental, and confirmatory testing
• Customized testing for unique sample types
Automation
• ACCELERATOR® a3600 Laboratory Automation System manages a high sample volume, while ensuring consistent testing and reduction in contamination and failure risk
• Real-time sample visibility and quality monitoring using Starlims®
• Operational continuity and surge capacity through integrated platform redundancy
• Streamlined ordering through AcQuire portal
Turnaround Time*
• Living and cadaveric donors: 24-48 hours average
• STAT testing available based on client needs
*Turnaround times customizable based on client requirements. All TATs are from sample receipt.
ACCELERATOR® a3600 Laboratory Automation System
PRODUCT SAFETY TESTING – HCT/P
Comprehensive Testing
• Liquid and allograft products
• Bioburden: RUO, GMP - USP <61> and ISO 11737-1
• Sterility: RUO, GMP - <USP 1223> in accordance with USP <71>
• Tissue culture swab
• Customized testing for unique sample types
• Validations and protocol development for non-standard products
Automation
• Milliflex Oasis® filtration system enables membrane-based detection of microorganisms
• BACT/ALERT® 3D performs aerobic and anaerobic testing with continuous, positive detection monitoring
• Streamlined test management through a secure microbiology client portal and LIS system
Turnaround Time*
• Bioburden: 8-12 days average with a 7-day incubation
• Sterility: 8-10 days average with a 7-day incubation 14-16 days average with a 14-day incubation
• Tissue culture swab: 8-11 days average with a 7-day incubation 14-16 days average with a 14-day incubation
*Turnaround times customizable based
MICROBIOLOGY TESTING SOLUTIONS
Microbial Detection
• Sterility: RUO, GMP - USP <1223> in accordance with <USP> 71
• Bioburden: RUO, GMP - USP <61> and ISO 11737-1
• Recovery testing
Microbial Identification
• Aerobic bacteria
• Anaerobic bacteria
• Mold/Fungi
• Yeast
• Gram stain
Microbial Qualification
• Growth promotion
• Testing for Aseptic Process
Simulation (APS)
Environmental Monitoring
• Surface microbial (contact plate)
• Air microbial (settle plate)
Additional Testing
• Endotoxin LAL
• PCR-based Mycoplasma
• Residual moisture
ENVIRONMENTAL MONITORING
Comprehensive Testing
• Contact and settle plate monitoring is used to detect microbial presence on surfaces or in the air that could impact product safety
• Organism identification performed on positive samples to support compliant production environments
• Microbial Qualifications: Growth promotion, testing for Aseptic Process Simulation (APS)
Automation
• BD Kiestra ReadA System automates incubation and digital imaging for settle plates and subcultures
• Daily plate readings accelerate early detection
• Preliminary reports available during incubation
Turnaround Time (TAT)
*
• 8-12 days average with a 7-day incubation
*Turnaround times customizable based on client requirements. All TATs are from sample receipt.
BD Kiestra ReadA
YOUR QUALTEX TEAMS
Corporate Account Executive (CAE)
• Primary point of contact to discuss the growing needs of your business
Strategic & Technical Onboarding Team
• Facilitates client onboarding and integration into QualTex’s testing ecosystem and laboratory processes
Customer Success Team
• Client-dedicated Customer Success Manager and extended resource team
• Provides support with routine updates on testing volumes and turnaround times
• Offers guidance through data-driven insights and periodic reviews
• 24/7 access to QualTex’s Customer Support Portal
CAPABILITIES BUILT OVER 50 YEARS
