Advancing knowledge and discovery in cardiovascular diseases through biospecimen storage and analysis

The Texas Heart Institute (THI) Biorepository and Biospecimen Profiling Core Laboratory is a tissue, blood, plasma, serum, nucleic acids, and other biological materials biorepository and research core laboratory dedicated to providing storage, blood processing, and biomarker profiling services to all investigators and institutions. We have been a College of American Pathologists (CAP)-accredited biorepository since 2015. Our state-of-the-art biosafety level 2 (BSL2) facility houses secure and 24-hour monitored freezers and a separate laboratory for processing and analysis with a dedicated cell-profiling room. Our highly trained staff and on-site, full-time Quality & Compliance Specialist provide cost-efficient, customizable research support, and laboratory services to meet the needs of investigator-initiated studies, large clinical trials, and industry research using biospecimens.

The THI Biorepository received accreditation from the College of American Pathologists (CAP) Biorepository Program in 2015, making it the first biorepository in Texas to receive this honor. CAP accreditation is awarded to facilities that meet the highest standards of excellence in quality laboratory practices. The THI Biorepository is also fully compliant with the US Food and Drug Administration current Good Laboratory Practices (cGLP) according to CFR21, part 58, and the International Society for Biological and Environmental Repositories (ISBER) biobanking best practices.

Biorepository Core Laboratory for the NHLBI Cardiovascular Cell Therapy Research Network and Cardiovascular Surgical Trials Network

For the past decade, the THI Biorepository has served as Biorepository Core Laboratory for the NHLBI Cardiovascular Cell Therapy Research Network and the Cardiovascular Surgical Trials Network. The de-identified biological samples—peripheral blood, bone marrow, plasma, serum, and tissue—stored by the THI Biorepository have been instrumental in helping investigators develop new insights into cardiovascular diseases in patients with acute myocardial infarction, heart failure, and peripheral artery disease and in those with a left ventricular assist device.

The THI Biorepository Advantages

• Convenient location in the heart of the Texas Medical Center
• College of American Pathologists accreditation
• GLP-compliant and equipped to convert to good manufacturing practices (GMP) regulations, if required
• Automated assay capabilities, requiring minimal human manipulation
• International Air Transport Association (IATA) certified personnel for safely transport hazardous materials by air in accordance with the Dangerous Goods Regulations (DGR)

Peace of Mind

All storage equipment is physically secured and monitored 24 hours a day 365 days a year using third-party and National Institute Standards and Technology (NIST) certified data loggers to ensure biospecimen quality. Back-up storage capacity is available for all temperature ranges with large dry ice reserves. Site-specific emergency action plans including back-up facility and freezers for all temperature range, and large dry ice reserves ensure continuous sample inventory and data protection, in the event of a disaster. Loss of power or functionality is mitigated by the Baylor St. Luke’s Medical Center’s auxiliary power and liquid nitrogen reserves.

SERVICES

BIOSPECIMEN TYPES

Our facility is equipped to process and store whole blood, buffy coats, plasma, serum, cerebrospinal fluid, DNA, RNA, bronchoalveolar lavage, frozen tissue, and bone marrow.

BIOBANKING SERVICES

• Study design consultation
• Collection of specimens to researcher specifications, from simple collection kits to ones containing over 100 specifications
• Training of clinical site personnel on protocol-specific procedures
• Complete spectrum of storage conditions—ambient, refrigerated, frozen, and ultra-cold
• Nitrogen vapor storage
• Bar coding
• Real-time reports on freezer temperatures
• Domestic and international shipping (IATA certified)

STANDARD BIOSPECIMEN PROCESSING

• Blood processing
• RNA and DNA isolation from specimens
• Cell counting and viability with an automated cell counter

BIOSPECIMEN ANALYSIS

• Cytokine profiling
• Protein counts
• Cell and tissue culture
• Functional cell assays
• Routine cytogenetic analysis
• Analysis of microRNA expression

BIOBANK INVENTORY

The THI Biorepository currently houses approximately 50,000 de-identified samples from multiple clinical trials in a CAP-accredited environment. Stored biospecimens include plasma, mononuclear cells, buffy coat bone marrow, bronchoalveolar lavage, and cardiac tissues. Researchers interested in applying for biospecimens from the THI Biorepository should complete and submit the Application.

Biobanked samples are derived from trial participants with a history of the following:

• Intermittent claudication
• Acute myocardial infarction
• Ischemic heart failure
• Left ventricular dysfunction secondary to anthracycline-induced cardiomyopathy
• Cardiac transplantation
• Lung transplantation
• Primary graft dysfunction

EQUIPMENT

The THI Biorepository & Biospecimen Processing Center has the following equipment:

• • Automated pipetting robot (Opentrons)
  • Custom-designed 6-laser flow cytometer (BD LSRFortessa^TM)
  • Automated sample preparation for flow cytometry (BD FASC^TM Lyse Wash Assistant)
  • Magnetic bead system cytokine/chemokine profiler (Luminex Magpix® with Xponent 4.1)
  • Multimode plate reader (Tecan Infinite® 200 Pro)
  • Spectrophotometer (ThermoFisher Scientific Nanodrop^TM Lite Spectrophotometer)
  • Real-time PCR (ThermoFisher Scientific QuantStudio^TM 6 Flex)
  • Three-parameter cell analyzer (Luminex Guava® Muse® Cell Analyzer)
  • Multielectrode array technology (Multichannel Systems MEA2100-HS60, FlexMEA36, EcoFlexMEA36, Glass MEA32-FAI)
  • LN2 vapor phase freezers
  • Refrigerators and freezers