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StemExpress’ Contract Bioservice Organization group, also known as Contract Research Organization (CRO), provides research and support services to pharmaceutical, biotechnological, and healthcare companies in their nonclinical and early phase stages, preclinical studies, and ongoing clinical trials. From testing new cell-based equipment during the developmental phase to organizing specific and recallable donors for clinical trials, our breadth of knowledge and scientific expertise enables us to meet clients’ needs and close the gap on time-to-market for their products.

StemExpress facilities comply with strict guidelines regarding the production, processing, and management of tissue-based cellular products to ensure the overall quality. Each facility complies with FDA CFR 1271 requirements of current Good Manufacturing Practices/Good Tissue Practices (cGMP/GTP) regulations covering human cells, tissues or tissue-based cellular products (HCT/Ps) for the use in clinical applications. The cGMP/GTP compliant facilities operate under strict, approved standard operating procedures (SOPs) and are managed using FDA CFR 1271 compliant Enterprise Resources Planning software (ERP) and Quality Management System (QMS), which is used to streamline manufacturing operations from order generation to product delivery. In addition, human tissue collection protocols are approved by the company’s Medical Director and Independent Review Board (IRB) in accordance with federal law.

As demands in human studies and advances in medical research become increasingly difficult due to soaring production costs and extensive developmental times, it is important to choose a partner that enables you to easily navigate barriers, enhance quality, and drive success in your research and clinical trials.

No matter what service we are providing, the bottom line is the quality and deliverability of your product.

What we offer:

  • Patient/donor selection
  • Specimen collection, storage, and transportation
  • Cell-based equipment testing
  • Blood and specimen kit development
  • R&D and clinical device development
  • Custom cell isolations

What you can expect:

A reliable partner.
Expectations and responsibilities are addressed before beginning each project to ensure the formation of a partnership and commitment to make the project work. Through this partnership, we promote an open means of communication to maximize the chance of success for completion of our service so that the final product meets all your criteria.

Strong team management.
With strong oversight and attention to detail, our CRO group provides expediency from order to delivery and guarantees every project meets your needs to ensure confidence in other stages of your research.

A controlled process.
We focus on the collection, analysis, and storage of the product and data associated with the administrative and operational processes, which includes regulatory requirements, collection procedures, primary cell isolation protocols, regulated storage, as well as quality control (QC) and quality assurance (QA), guaranteeing the integrity and relevance in the quality of your product.

Success stories:

  • Ariosa Diagnostics, Inc.
  • Verinata Health, Inc.
  • Grail, Inc.
  • Biomatrica, Inc.
  • Perkins Elmer, Inc.
  • Streck®
  • Cesca Therapeutics, Inc.
  • More…..

Hi, have questions?

A StemExpress Expert is happy to help!

Call 530.303.3828 or Contact Us