In-Vivo Lentiviral CAR-T

Lot Release Testing for
In-Vivo CAR-T Products

A Comprehensive Testing Panel for Confident Release

Minaris Advanced Testing provides fully integrated, GMP-compliant lot release testing solutions to support the development and commercialization of in-vivo lentiviral CAR-T products. Our scientific experts understand the unique complexity of lentiviral vector–based gene delivery systems and the critical quality attributes required to ensure safety, purity, potency, and regulatory compliance. We offer comprehensive testing panels for both Drug Substance (DS) and Drug Product (DP), tailored to your product design and global regulatory expectations.

Full Assay Name
DS
DP
Test Code
Minimum Sample Requirements
TAT (days)
Safety
Isolator Sterility Testing by Direct Inoculation USP<71> (GMP) – (Up to 100mL TA or 20 Vials)
✅
✅
3000004994
Per USP guidelines
21
Bacteriostasis and Fungistasis (Direct Method) (GMP)1
✅
✅
3000004996
Varies depending on fill/volume
21
Analysis of Bacterial Endotoxin Contamination Using Endosafe® nexgen-PTS™ (GMP)
✅
✅
3000005222
1 mL
7
Analysis of Bacterial Endotoxin Contamination Using the Endosafe® nexgen-PTS™ – Test for Interfering Factors (GMP)
✅
✅
3000005260
1 mL
14
EP, JP, and USP Mycoplasma Detection (GMP)2
✅
3000005147
1×15 mL & 1e6 cells/mL
35
EP, JP, and USP Mycoplasma Detection with Mycoplasmastasis (GMP)2
✅
3000007121
1×45 mL & 1e6 cells/mL
35
Mycobacterium Tuberculosis DNA Detection by qPCR (GMP)2
✅
3000005638
1e7 cells frozen
9
In Vitro Assay for Adventitious Viral Contaminants: MRC-5, VERO, and HEK Cells (Extended Duration) with Hemadsorption and Hemagglutination Endpoints (GMP)2
✅
3000005475
2×6 mL at 1e7 cells/mL
35
RCL Assay: Co-cultivation of Test Article Cells with C8166 Cells (GMP)2,3
✅
3000007915
1% or 1e8 cells (whichever is less)
56
RCL Assay: Amplification of Test Article Supernatant with C8166 Cells – Large Scale (5% of total supernatant, 200 mL to 300 mL) (GMP)2,3
✅
3000007492
5% or 300 mL of supernatant (whichever is less)
56
Microbial Safety Enumeration Test According to USP<61> (GMP)
✅
3000005066
2x specification
14
Microbial Enumeration Test Suitability <61> (GMP)
✅
3000005068
8x routine
21
Strength
Lentiviral Infectious Titer Assay with a qPCR Endpoint (GMP)4
✅
✅
3000005157
3×0.5 mL
35
Lentivirus Titer Determination by p24 ELISA (GMP)4
✅
✅
3000005164
1 mL
21
p30 ELISA (GMP)4
✅
✅
Custom
Varies
TBD
Genomic Titer by ddPCR for Customer Gene of Interest (GMP)
✅
✅
Custom
Varies
TBD
Potency
Product Specific Assessment Indicative of MOA (GMP)
✅
✅
Custom
Varies
TBD
Quality
Dynamic Light Scattering Analysis for Determination of Particle Size of Virus Lots (GMP)
✅
3000007812
0.1 mL
8
Determination of Appearance According to the USP (GMP)
✅
3000005469
2 mL
8
USP<697> and EP 2.9.17 Determination of Extractable Volume in Containers (GMP)
✅
3000005712
Varies5
14
USP<785> Determination of Osmolality (GMP)
✅
3000007458
0.1 mL
8
USP <791> Determination of the pH and Appearance (GMP)
✅
3000004853
1 mL
8
Identity
High Throughput Sequencing Using Ion Torrent Genexus (GMP)
✅
3000004999
Reference sequence, >/= 2e10 GC
18
Purity
Immunoenzymetric Assay for the Determination of HEK 293 Host Cell Proteins (GMP)
✅
3000004873
0.5 mL
21
Immunological Detection of Benzonase Endonuclease (GMP)
✅
3000004866
1 mL
8
Quantitation of Residual DNA Using PrepSEQ™ and TaqMan® Technology by qPCR (GMP) – 7 Targets 18S (102bp, 200bp, 254bp, 401bp-amplicons) + E1A + SV40 + E1B
✅
✅
Varies
1e7 cells frozen
TBD

1 Ingress Study may need to be conducted if the container has not been previously validated.

2 Testing performed on bulk harvest materials.

3 RCL assays can be customized to leverage a generic Jurkat cell line that has been developed to accommodate other vector targets or create a testing method for a different cell line to align with product specific vectors.

4 Infectious titer assay method can be customized as needed for product specific attributes and endpoints.

5 1 container if contents are 10 mL or more; 3 containers if volume is between 3 mL and <10 mL; 5 containers if volume is <3 mL.

Drug Substance (DS)

  • Our DS testing portfolio supports lentiviral vector intermediates and bulk drug substance with validated and phase-appropriate assays, including:

    • Identity – Genome confirmation, transgene verification
    • Strength – Infectious titer, p24, vector genome titer (qPCR/ddPCR)
    • Potency – Functional assay
    • Safety – Sterility, mycoplasma, endotoxin, RCL
    • Purity – Residual host cell DNA/protein, plasmid DNA, Benzonase
    • Quality Attributes – Osmolality, pH and appearance, particle concentration

Drug Product (DP)

  • For final formulated in-vivo CAR-T drug products, we provide comprehensive release support, including:

    • Identity – Genome confirmation, transgene verification
    • Strength – Infectious titer, p24, vector genome titer (qPCR/ddPCR)
    • Potency – Functional assay
    • Safety – Sterility, endotoxin
    • Quality Attributes – Appearance, pH, osmolality, fill volume, particulates
    • Stability Support – ICH-aligned stability programs

Product Specific Customization

  • In-vivo lentiviral CAR-T therapies present unique analytical challenges given that the vector is administered directly to the patient and must selectively and safely transduce immune cells within the body. As a result, Replication-Competent Lentivirus (RCL) testing and Infectious Titer (TU/mL) assays often require product-specific customization. Customization of these two assays ensures patient safety, accurate dose assignment, supports regulatory expectations and provides defensible data across phases.

  • For in-vivo CAR-T products, potency assays must also be customized as clinical activity depends not only on transduction efficiency, but on selective in-vivo targeting and functional CAR signaling driven by engineered vector design. Customization typically includes the use of biologically relevant primary or receptor-expressing target cells, along with measurement of CAR expression, downstream signaling, and functional activity (e.g., cytotoxicity or activation) in a matrix appropriate for the final drug product.

Why Minaris?

Minaris Advanced Testing combines specialized expertise in cell and gene therapy analytics with extensive experience supporting lentiviral vector programs across all stages of development.

Our GMP-compliant laboratories provide comprehensive method development, qualification, and validation services, backed by global regulatory support for FDA, EMA, and PMDA submissions—delivering the scientific rigor and reliability needed to advance your therapy with confidence.

Get in Touch With Our Team Today

Ready to discuss your in-vivo CAR-T lot release testing needs? Our team is here to help.

Contact Us