Biorepository Services I Medpace Central Laboratories

Biorepository Services with Medpace Central Labs

Medpace recognizes that translational medicine is driving an evolution in sample management and that samples are highly strategic assets. Biorepositories are a critical component of any clinical study, given the need for the highest quality specimen management. Therefore, the focus should be on comprehensive sample management solutions and not only the storage of samples. Key biorepository capabilities must include robust, quality processes for sample handling, storage, and tracking. Scientific expertise is a critical aspect of these project teams.

Comprehensive Sample Management Solutions – Not Just Storage

Medpace Biorepository is a regulated facility that follows essential guidance and industry standards from agencies around the world. The agencies include the College of American Pathologists (CAP), the World Health Organization Good Clinical Laboratory Practices (WHO GCLP), International Society for Biological and Environmental Repositories (ISBER), and the National Cancer Institute (NCI) best practices. Our biorepository functions with the level of compliance for services spanning the clinical trial continuum (e.g., proof of concept/early phase through late-stage). Medpace Biorepository Services offers solutions for comprehensive specimen life cycle management, which can begin with providing sample collection kits to sites through to receipt, processing, storage, retrieval, and destruction.

In cooperation with Medpace’s Clinical Pharmacology Unit, we provide opportunities to establish prospective studies for acquiring specific specimens to answer early program decisions or gain insight into clinical trial subject stratification. Medpace Central Laboratories is an industry leader in terms of customized, high-quality service for the pharmaceutical and biotech clinical development industries.

Biorepository or Biobank

A biobank is a type of biorepository, which typically stores only human biological samples. A biorepository is more inclusive and refers to the storage and management of specimens from animals, humans, and many other living organisms. Medpace not only has biobanking capabilities but also handles a variety of biospecimens for every stage of clinical development or academic needs.

Global Storage Capabilities

Medpace has repositories at our facilities in USA, Belgium, Singapore and China. Since each site also has responsibilities for managing clinical studies, the repositories and sample storage units are operated as per strict regulations and can expand as a clinical program grows. This means that there are always accommodations for your short-term or long-term specimen storage projects. Check with us to set up time to review your needs and onboard your project.

Inventory Risk Management

Split your inventory offsite using our regulated biorepository for disaster-risk mitigation and improving business continuity. Whether we bring your units to our facility or you use our own controlled storage, it’s something that should be part of your disaster preparedness. Our storage contingencies include a Biorepository area-dedicated natural gas (continuous feed) generator, with secondary generator fail over. Use our storage units with redundant compressors and LN2 back up and our cryogenic room with continuous feed from our on-site liquid nitrogen bulk supply. Rest assured, the state of the art Rees Centron Presidio Environmental monitoring system manages all controlled temperature storage units and areas. You will also appreciate that your critical inventory records and data are backed up and stored with us with an offsite redundancy server.

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Sample Processing

Medpace Biorepository also processes samples in a variety of ways including purifying whole blood and bone marrow for mononuclear cells, aliquoting, card spotting, buffering, acidifications, deidentifying/relabeling, etc. Other processing methods can be added customized per request.

Our peripheral blood mononuclear cell (PBMC) processing procedures are certified annually through an external Biospecimen Proficiency Testing Program in cooperation with the Integrated Biobank of Luxembourg (IBBL). This program compares our performance to other laboratories using these criteria: viability, cell yields, and functional performance in IFN‐gamma ELISpot assay.

Additionally, our Sample Processing technicians are qualified by a top 5 Pharma company for processing PBMC for use in their critical, clinical programs. This qualification was based on meeting their criteria for viability, cell yields, and functional performance in IFN‐gamma ELISpot assay.

Biobank Assistance

Whether you are an established biobank or at the start of setting one up, our in-house expertise can be valuable. Our biorepository leadership has years of practical knowledge with establishing and managing regulated biobanks in a pharmaceutical setting and is also CAP Accredited as a peer inspector for biorepositories. Before you get too far into the biobanking business, give us a call to see how we can help.

Medpace biorepository is a CAP accredited facility.

Experienced staff perform quality controlled processes.

Powerful database for fast and efficient sample accessioning and retrieval.

Use of cryogenics during shipping.

Use of cryogenics during accessioning of temperature-critical biomaterials.

Conditions include ambient, 4°C, -20°C, ultralow and LN2 vapor storage.

Technicians qualify equipment using thermal mapping technology.

Biorepository Highlights

CAP-accredited
Procedures follow ISBER and NCI Best Practices
19,000+ SF global Sample Management space
Real-time global tracking and tracing of specimens
Continuous 24/7 temperature monitoring with alarms and text/email alerts

Can’t get to our campus? Take a virtual tour of our central lab, bioanalytical lab, and biorepository.

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“Medpace’s biorepository isolated and cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) for one of our clinical studies, which had a stringent requirement of processing within a few hours from time of sample draw. Our study required functional T-cells to generate immunogenicity data in an ELISpot assay. All PBMC samples met assay acceptance criteria for cell concentration and viability and the scientists at Medpace demonstrated true expertise in every aspect of the process, from sample management to integrity of the cells.”

– Senior Scientist, Top-five pharma company

Biorepository Capabilities

Over 19,000 SF Sample Management space (US, EU, Singapore & China)
High-quality processes with expertise supporting therapeutically-focused studies for oncology, cardiovascular, CNS, and metabolic clinical research
Ambient, 4°C, -20°C, Ultralow (i.e. -70°C/80°C), & Liquid Nitrogen storage capabilities
Storage includes but is not limited to serum, plasma, whole blood, urine, DNA, RNA, PBMC, PK, FFPE/slides-blocks, bone marrow, cells and pellets, CSF, teeth, stool and research biomaterials
Use of cryogenics for shipping and receiving temperature critical biomaterials (e.g., cells, research product, etc.)
Backup generators and full business continuity plan
Powerful database for fast and efficient sample positioning and retrieval
Flexibility to manage study-specific processing including aliquoting, buffering, relabeling, and de-identifications
Comprehensive solutions for relocating your clinical specimen collections

“Medpace Reference Laboratories (MRL) provides central lab kits to one of our study’s clinical trial sites in the US as well arranges the transport of frozen samples from the sites to MRL, providing frozen storage until the samples are batch shipped to our UK sponsor. Every step of the process has been well managed by the MRL team. Communication with our sites and project team members has been stellar. They’ve played a huge role in re-education of sites regarding proper packing of frozen samples and have been super helpful with customs issues when shipping samples to the UK.”

– Project Leader, World’s Largest Academic Clinical Research Organization