Matt is a Senior CMC Consultant with over 25 years of industry experience, specialising in CMC analytical strategy for cell and gene therapies, biologics and recombinant proteins. He has led stability programmes, analytical method validation and QC readiness activities, and has authored and contributed to regulatory submissions from early development through to BLA approval. Matt also brings more than 15 years of experience in the development and validation of PK and ADA assays within GxP environments, including assays supporting the assessment of vaccine responses.
Expertise: Primary Service Skillsets:
CMC Analytical Strategy
• Method validation
• Stability programme design and execution
• Specification setting and reference standard lifecycle management
Regulatory CMC Authoring
• IND, IMPD and BLA submission authoring
• Responses to regulatory agency information requests
• Regulatory submission SME (vector QC, stability and method validation)
Bioanalytical Assay Development
• PK and immunogenicity (ADA) assay development and validation
• ELISA, SPR (BIAcore), qPCR, flow cytometry and ECL (MSD) platforms
• GLP/GCP bioanalytical study oversight
Additional Technical Specialisms
• Analytical Method Lifecycle & Tech Transfer: Proven track record leading method validation and transfer activities into GMP QC laboratories
• Global CDMO & CRO Management: Extensive experience managing global contract partnerships and working as an SME for analytical validation
• Team Leadership: Skilled in building and directing cross-functional teams, aligning stakeholders across development, QC and regulatory functions
• Vaccine Response Assay Development: Experience developing assays to support the assessment of vaccine responses across clinical trial programmes
• ELISPOT & International Technology Transfer: Track record developing, validating and transferring ELISPOT and immunoassay methods to clinical laboratories internationally
If you wish to learn more about Matthew click here.
If you would like to discuss your project with Matt or require specialist advice please get in touch.
