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Analytical Testing and Development

Driving Confidence Through Data-Driven Quality

Analytical testing lies at the heart of cell and gene therapy development, ensuring product identity, purity, potency, and safety through every clinical and commercial milestone. At Cell Therapies, we offer comprehensive in-house Quality Control and analytical testing services under a TGA-licensed framework. Whether developing an assay for pre-clinical research or validating GMP release methods, our team ensures your product meets regulatory expectations and patient needs.

Our analytical support spans early feasibility assessments to full GMP validation, always grounded in deep regulatory knowledge and collaborative technical consultation. We enable predictable, compliant CMC outcomes with digital traceability from raw data to CoA.

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Analytical Testing bench
Analytical Testing and Development at Cell Therapies

Quality Control And Analytical Testing

Licensed Analytical Testing

With 20+ years of experience, Cell Therapies provides robust analytical support for both autologous and allogeneic cell-based therapies. Our facilities are equipped with advanced instrumentation and digital infrastructure to ensure accurate, reproducible, and audit-ready results.

Our in-house analytical and QC capabilities include:

  • TGA-licensed flow cytometry (21 CFR Part 11 compliant)
  • ddPCR and qPCR-based assays
  • ELISA and cell-based potency assays
  • Rapid sterility via BacT/ALERT
  • Endotoxin and mycoplasma testing
  • Stability testing with cryopreservation protocols

These services are fully integrated into our GMP-compliant operations and available as standalone services or bundled with manufacturing and development programs.

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Core Analytical Capabilities

In-house Testing

High-dimensional identity and purity characterization

Our GMP-compliant, multiparameter flow cytometry platform supports up to 14 parameters and 12 fluorescence channels for product identity, purity, and phenotypic characterization. We develop and qualify panels for:

  • Immunophenotyping (CAR-T, NK, TCR)
  • Lineage-specific markers
  • Cell viability and exhaustion
  • Contaminating cell type detection

Procedures are designed and transferred into routine QC workflows with full traceability and 21 CFR Part 11 compliance.

Precision quantification using ddPCR and qPCR

We offer droplet digital PCR (ddPCR) and quantitative PCR (qPCR) assays for:

  • Vector copy number (VCN) determination
  • Residual transgene detection
  • Mycoplasma contamination screening

All PCR methods are validated under GMP with performance characteristics including:

  • Limit of detection (LOD)
  • Limit of quantitation (LOQ)
  • Accuracy and precision
  • Inter-operator reproducibility

These assays are essential for regulatory filings and lot release of gene-modified cell products.

Rapid and reliable sterility assurance

Cell Therapies performs in-house microbiological safety testing using:

  • BacT/ALERT dual-temperature sterility testing (rapid turnaround)
  • Endotoxin testing via kinetic chromogenic LAL
  • Mycoplasma detection using validated qPCR

These qualified assays meet international regulatory standards, supporting timely product release for time-sensitive autologous therapies.

Functional validation of cell potency

Cell Therpies’ portfolio of biological potency assays includes:

  • Cytotoxicity and cell-killing efficiency
  • Cytokine release (e.g., IFN-γ, IL-2 via ELISA or Luminex)
  • T-cell activation markers
  • CAR-T and NK cell functionality
  • Exhaustion and memory profiling

Assays are customized to product-specific MoAs and validated for consistency across manufacturing lots.

Real-world and accelerated testing strategies

We support stability assessments across fresh and cryopreserved formats with:

  • Real-time and accelerated stability studies
  • Cryo-hold protocols to assess shelf-life and transport robustness
  • Integration with release testing and CoA timelines

Start With The End In Mind

From IND to market, Cell Therapies supports your entire advanced therapy journey. Our consulting arm is powered by scientific, regulatory, and operational leaders who’ve guided dozens of CGT programs globally.

Services Offered

  • CMC Road-mapping & Regulatory Gap Assessments
  • FACT Accreditation & GMP Readiness Support
  • Quality Management Consulting (QbD, risk assessments, CAPA strategy)
  • Facility Build-vs-Buy Feasibility for early-stage innovators
  • APAC Clinical Feasibility Assessment and Country Selection
  • Regulatory Agency Meeting Support and Submission Strategy
  • Quality Consultation as a Service (QCaaS) – ongoing SME access

Engagement Model

Phase
Deliverables
Discovery
Scoping call
Preliminary assessment
Proposal
Scope of work
Timeline
Resource planning
Execution
SME-led sessions
Drafts
Advisory reports
Outcomes
Actionable strategy, slide decks, regulatory documents

Your Future-focused CDMO

Digitization is not optional—it’s a strategic differentiator. CTPL’s digital transformation enables predictive insights, real-time transparency, and compliant automation across manufacturing and QC.

Digital Initiatives

Tempo by Apprentice.io for digital batch records, cleanroom execution, and quality assurance
End-to-End Chain of Custody Tracking – track samples, materials, expiry, and batch lifecycle in real time
Remote Manufacturing Oversight – global clients gain virtual access to floor-level activities
Predictive Analytics – optimize processing time, detect bottlenecks, and manage deviations
Digital Tech Transfer Tools – reduce time and error in method and process handovers
IoT-Enabled Sensors – monitor environmental and equipment data in cleanrooms

Client Benefits

Shortened tech transfer timelines
Enhanced compliance and traceability
Reduced overhead on issue resolution and travel
Virtual oversight = faster decisions

Ensuring Safety And Efficacy Through Cutting-edge Analytics

Cell Therapies offers in-house Quality Control (QC) and analytical testing capabilities under a TGA-licensed framework. Our analytical services span method development, assay transfer, qualification, and GMP validation, supporting both process development and final product release. Every engagement is underpinned by close technical consultation and regulatory alignment, enabling predictable Chemistry, Manufacturing and Controls (CMC) outcomes for our clients.

Talk to us about your requirements
Analytical Testing at Cell Therapies
Careers at Cell Therapies

Service Highlights

Assay Development & GMP Qualification: End-to-end support from research use only (RUO) methods to validated GMP release assays
ddPCR Method Validation: LOD, LOQ, accuracy, and precision for critical release and comparability assays
Digital Audit Trail: Seamless traceability from raw data to Certificate of Analysis (CoA), fully integrated into CTPL’s quality systems
TGA-Licensed Capabilities: Includes flow cytometry, ddPCR, ELISA, sterility, endotoxin, and mycoplasma testing under GMP compliance
Platform Readiness: Optimized for iPSC-derived products , CAR-T, TCR-T, CAR-NK, and viral vector-based advanced therapies
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Core Capabilities

Identity
Multiparameter flow cytometry
Purity
Residual magnetic beads and viral vector clearance, cell viability assays, lineage marker analysis
Potency
Cell-based cytotoxicity assays, cytokine release (e.g., ELISA, Luminex), Droplet Digital PCR (ddPCR) for vector copy number (VCN)
Safety
BacT/ALERT rapid sterility testing, mycoplasma detection by qPCR, endotoxin quantification via Limulus Amebocyte Lysate (LAL) assay
Stability
Real-time and accelerated stability studies, cryopreservation hold-time protocols for both fresh and frozen formats
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Analytical Testing in the Cleanrooms

Unrivalled experience and service from a global leader in cell and gene therapy manufacturing

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cell therapies is an Australian-based, globally-active commercial contract development and manufacturing company, specializing in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products

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Victorian Comprehensive Cancer Centre
Level 9, 305 Grattan Street,
Melbourne, VIC,3000
Australia

+61 3 9492 4777
[email protected]

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