GI Partners Acquires CDMO and Cell Solutions
As Rose BioSolutions, the established CDMO and Cell Solutions businesses continue to support the biotechnology ecosystem with cell sourcing capabilities and CDMO services to accelerate your advanced therapy from development to delivery.
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Assay Development and Qualification to Assure Quality During Cell Therapy Manufacturing
To ensure success in cell therapy manufacturing, it’s important to establish stringent guidelines for assessing potential therapies. As your cell therapy analytical development partner, we determine the Critical Quality Attributes (CQAs) that are vital to monitoring the safety and efficacy of your cell therapy analytical methods to measure and monitor these attributes.
With the ability to support all stages of cell and gene therapy process development, our scientists specialize in the industry’s latest technologies for process innovation and analytical test methods. This expertise enables us to develop and qualify assays for the reliable assessment of cell identity, purity, potency, viability, and safety to ensure product consistency.
Cell Therapy Process and Analytical Development
Join our Director of Analytical Development, Sarah Campion, MS, and Director of Process Development, Alex Sargent, PhD, as they guide you along the commercial cell therapy pathway starting with key considerations in development through to IND/CTA filing and lot release.
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Our team of analytical experts includes dedicated project managers who bring a focus onto timelines, regulatory approvals, tech transfer, and accuracy with every stage of development so you can count on your product meeting the necessary quality and safety requirements.
Our analytical method development, optimization, and validation is positioned globally within our network of CDMO facilities and testing sites to ensure phase-appropriate capabilities for both standalone and integrated analytical projects.
Analytical Method Development Services to Help You Every Step of the Way
Our cell therapy analytical method development includes the execution of:
- In-process FIO testing
- Assay fit-for-purpose (FFP) studies
- Product characterization for process/site comparisons
- Material and intermediate hold-time studies
- Material/vendor comparisons
- Development of cell-based assays
- In vitro bioassays
- Binding assays
- Molecular biology
- Physical testing
- Extended characterization of CQAs/PQAs
Our analytical assay capabilities include, but are not limited to:
- Enumeration
- Flow cytometry assays
- qPCR and ddPCR
- ELISA/Ella technology
- Cell-based assays (ICC, CFUs, MLRs, Tumorigenicity, etc)
“Completing our master cell bank for CYWC628 is a defining moment in our work to advance fibroblast-based cell therapies. With this foundation in place, we are progressing on our path to the clinic in 2025 and strengthening our ability to collaborate with research and clinical partners worldwide. Our work with Charles River on this critical step will help ensure that we are fully prepared to scale CYWC628, positioning FibroBiologics at the forefront of fibroblast-based cell therapy innovation.”
Pete O’Heeron, CEO of FibroBiologics
We Put Quality at the Center of Everything We Do
Quality management system (QMS) meets all GMP guidelines for facilities, procedures, and systems suitable for clinical and commercial manufacturing
100% in-house analytical quality control (QC) test method development and testing capabilities for product-specific identity, potency, and purity testing on-site to streamline supply chain
100% in-house microbiological capabilities using rapid methods for rate limiting safety tests (endotoxin, mycoplasma, and sterility) reducing release timelines
Extensive phase-appropriate assay qualification and validation expertise to ensure manufacturing robustness and regulatory compliance
Confidently Advance Your Cell Therapy Analytical Development with a CDMO Partner
When you work with Charles River, you get the expertise and power of a larger CDMO combined with the intimate support of a dedicated partner. We can help you:
Ensure Your Products Meet Regulatory Requirements
Our team of cell therapy analytical development experts brings extensive experience to your cell and gene therapy project to help you develop and validate analytical methods, characterize cell products, and perform release testing.
Limit Capital Investment
Our analytical and process development labs are fully equipped with specialized equipment for flow cytometry, gene expression analysis, and other complex analytical method development and validation techniques.
Accelerate Your Development Timelines
By adapting and customizing our standardized workflows and protocols to meet your needs, we can reduce the time it takes to develop and validate cell therapy analytical methods and ultimately reduce the time required for release testing.
Mitigate Risks
By partnering with a CDMO for cell therapy analytical development and validation, you reduce the risk of unexpected delays or failures in the manufacturing process. Our established quality systems and regulatory support help to ensure your final product meets regulatory requirements and is safe and effective for patients.
Rapid, Seamless Transition to GMP Manufacturing for Cell Therapies
Streamline your supply chain, save time and money with a single partner for cell therapy process development and manufacturing. Our team can accelerate the development of your cell therapy, negating the need for bridging and validation studies, while maintaining quality.
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Frequently Asked Questions (FAQs) About Cell Therapy Analytical Development
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What is analytical development in cell therapy?
Analytical development in cell therapy involves the development and optimization of methods and tools to evaluate the quality, safety, and efficacy of cell-based products. Because cell therapy products are highly complex, it’s essential to establish robust analytical methods and validation to ensure the consistency and reproducibility of cell therapy products.
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What analytical equipment do you use?
Our analytical equipment includes but is not limited to:
- Cell counters: Chemometec NC-200*, Sysmex XP-300, Nexcelom Auto 2000, Moxi-Go II, Bioprofile Flex 2
- Flow Cytometers: BD FACSLyric*, MACsQuant 16, Accelix
- PCR: QuantStudio 7 Flex*, ddPCR – BioRad QX200
- Immunoassays: Spectramax iD3*, Luminex MAGPIX, BioTEK ELX50*, ELLA*
- Imaging: BioRad ChemiDoc, ThermoFisher EVOS*
- Other: Maestro (impedance reader)
*Platform of choice for QC
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