Cell and Gene Therapy

Cell and Gene Therapy Laboratory Services

Alcami specializes in developing innovative solutions for Cell and Gene therapies. Our expertise spans autologous and allogeneic modalities, providing comprehensive support throughout the drug development lifecycle. We offer comprehensive analytical method development and QC testing, stability studies and cGMP storage solutions to ensure product quality and regulatory compliance.

    • Stand-alone services for Cell and Gene Therapy
    • Transforming academic and R&D assays into a format suitable for quality control.
    • Potency assay development, optimization, qualification, and validations
    • Advanced characterization, including Bioseparation and Bioassays
    • Robust assay performance using cGMP standards for various test articles
    • Supporting drug candidate screening and process optimization using R&D or validated assays
    • Product safety testing including Residual HCP & DNA, Mycoplasma by qPCR, Bioburden & Endotoxin, Sterility & CCIT, Sub-visible Particulates 
    • Analytical cell bank generation, testing

Specialized Analytical Support for Cell Therapies

1. Autologous and Allogeneic

Liquid nitrogen workflow available in the lab to avoid temperature excursions
2. In Vitro Potency Assays

Cytoxicity

Cytokine detection

Cell Migration assays

Cell differentiation assays

Onboarding niche analytical equipment
3. Characterizations

Cell phenotype

CAR/cargo molecule expression

Viability

Residual Virus copy number

Residual process impurities

Specialized Analytical Support for Virus-based Gene Therapies

1. Virus-based drug product handling

AAV

Lentivirus

Other viral products on a case by case basis
2. Broad Subject matter expertise

Virology

Molecular Biology

Cell Biology

Protein Biology
3. Complex Impurities Profile

Custom and platform impurity testing assays by HPLC, Mass Spectrometry and/or binding assays
Summary

Alcami leads in innovative solutions for Cell and Gene Therapies, supporting autologous and allogeneic modalities throughout the drug development lifecycle. Our offerings include analytical method development, QC testing, stability studies, and cGMP storage solutions to ensure product quality and regulatory compliance. Specialized services include potency assay development, advanced characterization, and safety testing for Cell and Gene therapies. With expertise in virology, molecular biology, and impurity profiling, Alcami delivers tailored solutions to accelerate therapeutic advancements. Contact us to learn more.

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