Cellular Therapy

Carter Bloodcare is a leader in advancing the cellular therapy (CT) field. Carter Bloodcare’s cellular therapy program supports both clinical and research use of cellular products. Our services include apheresis CT collections, providing other CT source material, and processing/storage of multiple CT products. Our team has extensive experience in the cGMP manufacturing process.  We have been performing CT collections and processing for over 20 years and have maintained continuous accreditation with FACT and AABB.

Research Collection and Laboratory Support

Cellular Therapy Starting Material

Carter BloodCare offers an array of CT source material that could be used in either clinical or research settings and includes:   

• Stem cells (mobilized leukopaks*)  

• Mononuclear cells (non-mobilized leukopaks*)      

• LRS chambers

• Buffy coats

*All research leukopaks are collected using an IRB-approved consent and can be shipped fresh or frozen.

Cellular Therapy (CT) Laboratory Services

CELLULAR THERAPY FACILITIES

Cleanroom Rental

The cleanrooms, located within Carter BloodCare’s headquarters in Bedford, Texas, are expected to be available for rent by Winter 2023 for researchers, science and technology firms, medical device companies and others who need to conduct temporary, or permanent, controlled manufacturing and operations for their products. Click the button below to request more information or to reserve the dates and specific cleanrooms your company needs.

Clinical Program Collaboration

CT Collections for clinical programs

The Clinical Apheresis team at Carter BloodCare provides comprehensive support for cellular therapy clinical programs. Our team of apheresis specialists perform the collections for both pediatric and adult donors.  We perform the collection of the following products in both hospital and outpatient settings for programs throughout Texas:

• Autologous and allogeneic hematopoietic peripheral blood stem cells (HPCs)

• Autologous and allogeneic mononuclear cells, including donor lymphocytes

We currently perform collections for several clinical trials and collaborate with clinical programs and trial sponsors to customize workflows and procedures based on protocols.

We also work closely with our clients throughout the pre-screening process by performing peripheral vein evaluation of the donor to determine venous access and by assisting to determine donor eligibility.

CT Laboratory Services for Clinical Programs

The cellular therapy (CT) laboratory provides services to multiple bone marrow transplant programs both within and outside of the Dallas - Fort Worth Metroplex. Our team has expertise in processing autologous and allogeneic hematopoietic progenitor cells (HPCs) derived from peripheral blood and bone marrow, as well as preparing cord blood units (HPC-CB) provided by private or public cord blood banks for transplantation. In addition to these CT products, the laboratory handles mononuclear cell (MNC) products, as well as investigational study products. The staff is comprised of board-certified medical laboratory scientists (MLS) who have received specialized training in the handling of cellular therapy products to include processing, cryopreservation and preparation for infusion.

Apheresis and Marrow Processing

Each CT product is routinely evaluated for ABO/Rh, total nucleated cell concentration, CD34 content if HPC or CD3 if MNC(A) or allogeneic HPC products, cell viability and microbial contamination. In addition, red cell compatibility and CD3 enumeration are performed on allogeneic HPC products. Other evaluations are available upon request.

Depending on the type of graft, the following manipulations are available:

• Plasma reduction

• Manual and automated methods of buffy coat preparations

• T-Cell Depletion

• CD34 Selection

• Donor Lymphocyte Infusion (DLI) cell dosing

Cryopreservation and Storage

All cells are cryopreserved using a controlled-rate freezing process which allows for long-term storage of cells. The temperature of the cells is continuously monitored throughout the freezing process. When the cells reach approximately -90°C, they are transferred into a liquid nitrogen storage freezer.

Liquid nitrogen storage freezers:

• Stored onsite in secure areas with authorized-access only  

• Colder than -150°C

• Continuous temperature monitoring

Transportation and Infusion Support:

Carter BloodCare CT staff have the ability to receive, cryogenically store, transport and thaw products for local customers and transplant facilities based on the product and/or study protocol:

• Cryopreserved products are transported in a validated liquid nitrogen shipper.

• Liquid products, such as fresh marrow and thawed cord blood, are transported in a validated transport cooler.

• Once at the patient’s bedside, the CT product is properly verified with the physician’s order and patient identification.

• If cryopreserved, CT products are thawed by the CT lab at the patient’s bedside prior to issue.

Bone Marrow Collections

The CT laboratory has been trained in sterile surgical techniques and can assist the transplant physician in the operating room during bone marrow harvest procedures. The laboratory prepares an appropriate amount of suitable media to be used during the harvest and provides a sterile container for collected marrow. During the procedure, the CT technologist will monitor the amount of the harvested bone marrow. At the completion of the harvest, a member of our team will filter the bone marrow product and label according to established regulatory requirements.

• Autologous and allogeneic bone marrow harvest assistance

• Staff trained in surgical aseptic and sterile field techniques
  

HPC-Cord Blood Storage, Thawing and Infusion

Once the transplant facility selects a cord blood unit as a match for a patient, the transplant facility coordinates shipment and delivery of the selected cord blood unit to the CT laboratory. Upon arrival, the identity and the integrity of the product are verified and placed into a liquid nitrogen storage freezer until the patient is ready for transplant.

On the day of transplant, the CT laboratory will thaw the component and prepare it for transplant per the physician’s instructions: 

• Reconstitute prior to infusion

• Wash and reconstitute to remove cryoprotectant and cellular debris prior to infusion