Biological Resource Support

Facilities

In our state-of-the-art facilities, we store your samples under constant temperature monitoring at room temperature, +4°C, -20°C, -80°C, and liquid nitrogen (LN₂). Our facilities, located throughout the Baltimore-Washington metropolitan area, minimize risk and optimize material management including receipt, testing, storage, and distribution. All our facilities are equipped with alarm systems that monitor facility-wide adverse conditions such as fires, unauthorized access, and equipment malfunctions.  We have protocols in place for temperature excursion notification, back-up generators, and sample transfer. For additional sample security, we recommend that our government clients follow the best practice of storing multiple aliquots of the same sample in different storage units and/or across multiple ATCC facilities.

Since 1996, ATCC has been authorized by the Centers for Disease Control and Prevention (CDC) and United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) to possess, use, and transfer select agents and toxins. Our existing facilities feature Biosafety Level (BSL)-1, BSL-2, BSL-2 enhanced (BSL-2+), BSL-3, and BSL-3 enhanced (BSL-3+) laboratories for production, containment, and distribution. The CDC/USDA has inspected all applicable laboratories where we are registered for work with highly pathogenic biospecimens under the United States Federal Select Agent Program. 

Sample handling

ATCC manipulation of biological samples and pharmaceutical products includes weighing, dispensing, aliquoting, and labeling. We dispense both large and small volumes of materials using handheld devices, peristaltic pumps or automated equipment depending on the volume. We have dispensed and aliquoted millions of biological samples and chemicals such as: 
 

• Human biospecimens
• Cell lines / cell lysates
• Derivatives / reagents / components
• Viruses and other infectious organisms
• Drug compounds
• Chemicals, investigational drug products, antivirals

Inventory management

Our modern inventory management systems assure accountability and traceability of your government materials. Our technical teams use multiple electronic inventory management platforms, including platforms shared with government agencies and their stakeholders, to document full life cycle sample tracking. Routine physical inventory activities confirm data accuracy. We also develop and manage dedicated website portals for government user communities that serve as a single point for registration, ordering, depositing, documents, and customer service.

Program management

ATCC has over 50 years of successful government contract management experience of repository programs. Our PMP-certified project management team uses the processes, procedures, and standards defined by the Project Management Institute in the Project Management Body of Knowledge (PMBOK®) as the principal guidelines for the management of all internal and external activities. This covers best practices for initiation, planning, implementation, conduct / monitoring and closing processes. Our proactive approach to program management minimizes government risk and allows for efficient, flexible support to changing government priorities. We have supported the government’s responses to infectious disease outbreaks and pandemics to include the SARS-CoV-2 pandemic, the 2009 swine influenza pandemic (H1N1pdm09), the 2011 influenza pandemic (H3N2), the 2013 avian influenza pandemic (H7N9), and the 2015 Zika virus outbreak.

Authentication and quality control

Authentication and quality control (QC) tests are performed on ATCC products to assure identity and performance of the material are within acceptance criteria specifications.  Our authentication tests  verify the identity, purity and/or functionality of the material for its intended use. Our QC tests provide lot-specific specifications and serve as the criteria to qualify the initial and subsequent lots as equivalent to the authenticated source material. Authentication and quality control tests commonly used for ATCC microbes and cell lines include: 

• Genotypic tests
• Phenotypic tests
• Viability
• Purity and contamination
• Functional activity
• Composition or concentration

Quality management and best practices

Our facilities comply with our International Standards Organization (ISO) 9001 accredited Quality Management System (QMS), which provides oversight of materials, data, and procedures in order to assure reliability of results and sample safety. We also follow International Society for Biological and Environmental Repositories (ISBER) best practices guidelines for repository management. We operate in accordance with the Office of Science and Technology Policy (OSTP) requirement for good stewardship of scientific collections by federal agencies, Office of Management and Budget (OMB) clearance, and Institutional Review Board (IRB), and confidentiality requirements.

Clinical Study Support

ATCC provides clinical and epidemiological study support to include provision of collection supplies, sample receipt and storage, biospecimen processing, and distribution.

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Global Health and Biodefense

ATCC supports government agencies with R&D services, subject matter expertise, diagnostic tools, and surveillance kits for infectious and chronic diseases.

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