Therapeutics

Therapeutics

CAR Construct Design and Development

Alpha Immune supports a full CAR-T or -NK workflow, from creating CAR to functional testing and validation of therapeutic product

Below are some CAR design examples but we can design any CAR construct
  • CRISPR/Cas9-based CAR Construction.CRISPR-Cas9, a genome-editing technology as well as other technologies, are being used to generate “off-the-shelf” CAR-T cells. Ablation T cell receptor alpha constant (TRAC or TCR) and also β-2 microglobulin (B2M) by CRISPR-Cas9 technique can support the manufacture of universal CAR-T cells for off-the-shelve-allogeneic healthy donors CAR T cell product. 
  • Armed CAR Construction.The Armed CAR-T cells utilizes multipronged approach to target tumor cells and immune suppressive tumor microenvironment.
  • Bi- and Tri-Specific CAR Construction. Bi- and Tri-Specific CAR can simultaneously target two or three tumor antigens on a single cell or heterogeneously expressed tumor antigens on different tumor cells to avoid antigen escape.
  • TandCAR Construction. Tandem CAR design is bivalent enabling increased antigen avidity by CAR T cells to enhance T cell activation and function. 
  • VHH-based CAR Construction. This Nanobody is the variable domain of heavy-chain (VHH, it retains complete function is spite of being smallest in size.

Bispecific Antibody Design & Development

Alpha Immune supports full Bispecific Antibody platform, from creating Bi- or Tri-specific Antibody to functional testing and validation

Material Processing and Manufacturing Services

The cGMP personnel have extensive experience in cell manipulation, growth, and transduction of lymphocytes and other immune cells. The cGMP facility provides material processing, modification, production, analysis and support services.

Processing of pheresis product, peripheral blood or bone marrow aspirate

Manufacturing of cell-based therapies and chimeric antigen receptor (CAR) T cells
Manufacturing of T regulatory cells (Tregs)

Quality Control (QC) Services

Alpha Immune offers full QC testing of the cellular product that includes cell viability, phenotyping, identity and potency of the product with Certificate of Analysis forms prior to the release of cell therapy product for infusion in patients.

Sterility Testing. We offer sterility testing for bacteria, fungi, mycoplasma, and bacterial endotoxins.

Shipping Instructions and Supply for Cell Product Quality Testing.  At the customer’s request, we can provide shipping instructions, boxes, data loggers, and anything else that is required for shipping specimens. Alpha Immune can also train and qualify customers in sample processing, freezing, and shipping procedures. Under this scenario, the clinical site would conduct a dry run in which they would process preliminary specimens to be tested by Alpha Immune.

Clinical Trial Support. All immunotherapy monitoring studies conducted in support of clinical trials are carried out to GLP standards. Our commitment to quality is evident in every assay and every project we do. We’ve incorporated the following features to ensure the quality of our data: