At Matica Biotechnology, we use our innovative processes, latest equipment and advanced analytics to develop assays. From feasibility testing to validation, our experts offer full analytical services covering preclinical to commercial stage, according to your need and regulatory requirements.
Assay Development Capabilities
Analytical methods are employed to evaluate specific characteristics of material generated during processing. Some examples of these characteristics are infectious titer, potency, and residual host cell protein. Individual, product-specific assays will be developed to evaluate appropriate parameters for the product as described in the ICH guidelines Q2(R1).
Analytical parameters will be assigned based on the specific assay method, using ICH guidelines together with product historical data. For instance, an assay to determine genomic concentration by ddPCR would include Accuracy, Precision, Linearity, Specificity, and Range. These assigned parameters will interrogate the assay for its suitability, and when met, the assay is considered valid.
Analytical Development at Matica Bio offers
- Streamlined method transfer, development & optimization
- Phase-appropriate validation & transfer to QC testing lab
- Development of a GMP-grade bill of materials
- A high-quality raw material testing program