Analytical services
At Stemmatters, we understand the vital role of a robust analytical framework in ensuring your products' identity, purity, potency, and safety. We offer comprehensive analytical development services, including tailored assays and analytical methods designed to meet each product's specific needs. Our expertise ensures regulatory-compliant validation and reliable analytical outputs support every stage of development and manufacturing.
Analytical development
Custom analytical strategies for every stage of product development. We partner with you to manage the entire analytical development lifecycle, ensuring the consistency and quality of your product. By establishing an Analytical Target Profile (ATP) as the foundation for method development and validation, we ensure all methods are fit for purpose, specific, and compliant with regulatory requirements.
Method development
Our process begins with an in-depth evaluation of your program, analytical strategy, and key process parameters. From this, we design and implement tailored methods or refine existing ones, aligning with the Critical Quality Attributes (CQAs) and Quality Target Product Profile (QTPP) of your product.
Method transfer
For pre-established methods, we create a robust transfer protocol to ensure a seamless, compliant transition to our Quality Control (QC) laboratories or external partners. We also apply risk management to assess and execute any required revalidation processes.
Method validation
As your product progresses, we validate analytical methods and assays across multiple product types, adhering to industry standards and regulatory guidelines. We also conduct compendial method verification to confirm that methods are suitable under actual conditions of use.
Assays and techniques
Comprehensive in-house expertise for in-process testing, product characterisation, and final product quality control. Stemmatters offers an extensive portfolio of analytical methods for in-process testing and final product release, aligned with client requirements and regulatory guidelines such as Eur. Ph and USP. Our capabilities include:
- Live cell analysis: assessing cell number, proliferation rate, size/shape, and substrate attachment quality
- Flow cytometry: analysis of surface and intracellular marker expression
- Biomolecule quantification: using ELISA and multiplex techniques (e.g., cytokines and growth factors)
- Sterility testing
- Endotoxin testing
- Mycoplasma testing
- Closed Container Integrity Testing (CCTI)
- Cell differentiation assays
- Customised assays: including functional assays tailored to specific requirements
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