Services

SERVICES

Therapeutics

Immune Monitoring

Correlative Biomarker Screening

Serum cytokine/chemokine levels are quantified using the Luminex Protein Array System, a multiplexed, particle-based assay that simultaneously

Therapeutics

  • Construct Design and Development for CAR T or NK cells
  • Bispecific Antibody Design & Development
  • cGMP Production of Biologics and Cellular Therapy Products

Pharmaceutical Research

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Chemical Research

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Pharmaceutical Research

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Mineral Assay Testing

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Biochemistry Solution

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Pharmaceutical Research

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Chemical Research

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We support a full CAR-T workflow, from creating CAR-T cells to functional testing and validation.

  • CAR biomarker identification & selection
  • High affinity scFv generation
  • CAR design & construction
  • Virus packaging & CAR transfection
  • CAR in vitro assay
  • CAR pre-clinical in vivo assays
  • IND enabling studies

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 as well as 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 retained complete function is spite of being smallest in size.

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

  • Separation and cryopreservation of patient/donor PBMC from whole blood or bone marrow aspirate
  • Monocyte depletion of pheresis product
  • Cryopreservation of pheresis product

 

Manufacturing of cell-based therapies

Manufacturing of chimeric antigen receptor (CAR) T cells

  • Activation of T cells
  • Transduction of activated T cells with retroviral or lentiviral vector
  • Remove beads and wash cells
  • Expansion of gene transduced cells
  • Determination of viral copy number
  • Cryostorage of CAR T cells
  • Quality Control/Quality Assurance (QC/QA) of cell therapy product

 

Manufacturing of T regulatory cells (Tregs)

  • Activation and Differentiation of Tregs
  • Cryostorage of Tregs
  • Quality Control/Quality Assurance (QC/QA) of cell therapy product

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: 

  • All data is stored securely with controlled access
  • All samples are run in duplicate with CVs reported
  • All studies adhere to the quality control process
  • We maintain full tracking of reagent lots and batch numbers
  • We ensure a full audit trail from raw data to delivery
  • The GLP facilities include dedicated, alarmed control rooms
  • Sample integrity is ensured with alarmed storage and temperature tracking facility freezers