Clinical Capabilities

Closing the Loop

to Clinical Commercial and Clinical Healthcare

StemExpress Clinical Brochure

From Product Development to Clinical Commercial

The mission of StemExpress is to promote the exploration and advancement of life-saving therapies, from research and development to clinical commercialization. With vast expertise in the pre-clinical, clinical, and healthcare space, StemExpress knows the importance of moving projects through all phases while ensuring scalability within the healthcare realm. As more commercial therapies are moving to approval stages, the need for clinical-level partners to support these projects is at an all-time high. StemExpress can help support these clients and close the clinical loop in the drug discovery process through flexibility, experience, partnerships, cold chain logistics, and targeted donor recruitment at StemExpress’s 8 locations nationwide – supporting projects and improving patient outcomes around the globe.

StemExpress Clinical Brochure
StemExpress Clinical Brochure
StemExpress Clinical Brochure

RUO vs GMP

Clients have different needs depending on their projects and StemExpress consults with each client on an individual basis to determine compliance for clinical trials in the U.S and other countries. With years of experience working directly with the FDA and CBER, StemExpress has unique expertise in providing IND filing support for clients seeking to move into the clinical space. Our laboratory offers customized capabilities to meet the requirements of conducting research with EMA and HTA compliant testing by adding on additional infectious disease testing at multiple timepoints. 

StemExpress Clinical Brochure

Coast-to-Coast

Donors

StemExpress Clinical Brochure
StemExpress Clinical Brochure

6 coast-to-coast collection centers with clinical capabilities

  • Broad and/or targeted donor recruitment efforts across 6 states
  • Collections take place in safe, clean, private collection rooms
  • Unprecedented access to rare, diseased and targeted donors
  • Highly effective donor retention protocols
  • Strict guidelines and quality standards - ensuring consistent, compliant, viable, and pure cells with guaranteed counts
  • Pre-screening for CAR T-cell and NK
  • Backup donors for engineering runs
  • Local same day delivery within 150 miles
  • Customizable donor/patient questionnaire
  • Global reach & delivery
  • Good Tissue Practices (GTP)
  • All sites FDA Registered
  • Screening for target genetics

Access to a diverse donor pool is key to the successful development of new therapeutics. With 6 locations nationwide, the StemExpress donor pool is one of the largest HLA-typed and most characterized in the industry. All collection centers are FDA registered, and boast on-site state-of-the-art laboratories, providing an end-to-end service whereby cells are processed, isolated, and cryopreserved or shipped out fresh immediately after collection from a donor.
Choosing a complete partner in clinical research starts with a reliable donor base - from demographic diversity and targeted recruitment to recallability and retention. StemExpress focuses on finding the right donors for a project, with customizable IRB consents and downstream protocols to fit the clients needs. Once a donor is fit to a project, StemExpress works diligently to ensure recallability, with expert donor retention strategies in place.

Clinical

Commercial

High quality source material for the process and development phase of research

For over a decade, StemExpress has led the way in supporting Allogeneic cellular therapies by supplying high quality source material for the process and development phases of research. Because these therapies have the potential to affect a considerable amount of people, the FDA has stringent guidelines for the procurement of donor blood and tissue samples. Our GTP tissue collections meet the rigorous FDA 21 CFR 1271 regulations, ensuring reliable cell collection, isolation, processing and storage. StemExpress also implements extensive donor screening, testing and GTP compliance in an effort to prevent the introduction and transmission of communicable diseases. We offer our clients vast resources, giving access to our 6 distinct donor pools. Our extensive network can provide immeasurable value, ensuring optimal donor selection for cellular material that is tailored to a specific project.

StemExpress Clinical Brochure
StemExpress Clinical Brochure
StemExpress Clinical Brochure

Map of StemExpress Locations and CMOs

We are uniquely positioned to accommodate the needs of our commercial clients. Our collection centers with clinical capabilities are strategically located near major healthcare and CMOs to allow for rapid turnaround times from point of collection to use in your research -
eliminating the timely logistics that can lead to cell death and compromise viability.

StemExpress Clinical Brochure
StemExpress Clinical Brochure
StemExpress Clinical Brochure

Clinical GMP Cleanroom Units

StemExpress proudly operates two BioSpherix Xvivo X2 closed system ISO5 GMP units within its laboratory, fully outfitted to deliver clinical GMP compliant starting material for cell and gene therapy projects. The environment in the 2 suite BioSpherix Xvivo is calibrated to ensure optimal conditions for cells to thrive, including airflow, gas, and temperature regulation. This is expertly designed compact cleanroom allows laboratory technicians to operate freely within the laboratory, while never compromising samples within the unit through human error and contamination. The Xvivo provides continuous audit tracking - monitoring particle count, environment, user logs, outages and errors - meaning full accountability at every single step.

StemExpress Clinical Brochure

Closed System Cell Manipulation

The CliniMACS Prodigy ® distills a full-scale GMP laboratory into a single unit capable of performing cell isolations and manufacturing clinical products for pharmaceutical, therapeutic devices, allogeneic and autologous production. The closed system produces GMP cell isolations straight from apheresis without any exposure to external environmental contaminants, ensuring patient sample integrity is never compromised. Through this groundbreaking device, StemExpress can partner with clients to run samples and create a cell therapy product, alleviating the need for hospitals to house and operate cumbersome laboratory equipment. This closed system processing is approved by the FDA for clinical use - Miltenyi offers multiple isolation kits, or custom technology can be uploaded onto the device as needed for specific projects under research partner’s or hospital’s regulatory guideline compliance.

StemExpress Clinical Brochure

Clinical

Healthcare

CAR T-Cell Therapy Partnership

Is your patient ready to recieve therapy? StemExpress also offers patient intake for apheresis collections at 6 collection centers across the nation - providing clinical Leukopaks ready for CAR T-cell manufacturing and re-infusion. We are uniquely positioned to accommodate the needs of your autologous therapies and are strategically located near major hospitals to allow for ease of access for patients. StemExpress can also manufacture cells, following hospital SOPs and under the hospital’s regulatory compliance.

StemExpress Clinical Brochure
StemExpress Clinical Brochure

CAR T-Cell Therapy Partnership Wheel

StemExpress Clinical Brochure

Accelerate Your

Therapies

StemExpress Clinical Brochure
Cate Dyer-Spears, CEO and founder of StemExpress

Your Complete Partner in Cell and Gene Therapy

"Our success is measured by the success of your projects - we help guide you every step of the way, so you can get your therapies to the patients who need them."

Cate Dyer-Spears, Founder and CEO, StemExpress

Let's Take the Next Step

Download Our Clinical Capabilities Brochure

What You'll Learn About

  • Unprecedented Support from Product Development to Clinical and Commercial Production
  • Coast-to-Coast Domestic Donor Network
  • Clinical Grade Apheresis Available Across the U.S.
  • Our GMP Laboratory & the Industry's Best Equipment
  • Supporting Clinical Research - Allogeneic and Autologous
  • Clinical Grade Products
StemExpress Clinical Brochure
StemExpress Clinical Brochure

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LEARN MORE ABOUT STEMEXPRESS

We are the leading global biospecimen provider of human primary cells, stem cells, bone marrow, cord blood, peripheral blood, and disease-state products

Advancing Medical Breakthroughs

StemExpress Clinical Brochure

Advancing Medical Breakthroughs

Founded in 2010, we know how important biospecimens are to medical research and how frustrating it can be waiting for samples.

StemExpress is dedicated to accelerating research projects at life-changing speed to aid in the development of new treatments and even cures for patients worldwide.

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About StemExpress

Founded in 2010 and headquartered in Sacramento, California, StemExpress is a leading global provider of human primary cells, stem cells, bone marrow, cord blood, peripheral blood, and disease-state products. Its products are used for research and development, clinical trials, and commercial production of cell and gene therapies by academic, biotech, diagnostic, pharmaceutical, and contract research organizations (CRO’s).