Independent bioprocess consultancy and GMP support for drug product, CMC, tech transfer, MSAT and fill-finish. Flexible engagements — from short technical reviews to multi-month embedded support — covering the full lifecycle of a biologic or advanced therapy programme. Learn more about my background, see selected work, or get in touch.
Subject matter expertise for DP manufacturing, PPQ campaigns and commercial launch readiness. Batch documentation, validation, risk analysis and stability plans.
Cross-functional CMC support across Drug Product, Medical Device, Labelling and Packaging — including regulatory submissions and Health Authority responses.
Transfer of bespoke biologics and ATMP processes into CMOs and internal sites, with a platform-first GMP approach.
Hands-on MSAT support for upstream, downstream and fill-finish — including cell & gene therapy hardware such as the Miltenyi Prodigy.
Bespoke and high-viscosity drug product/substance filling, prefilled syringe systems and combination products.
Helping academic groups and early-stage biotechs make the leap into industrial pharmaceutical development with the right CMC foundations.
A sample of recent and representative engagements. Client names withheld.
Embedded MSAT support for a clinical-stage CAR-T programme manufacturing on the Miltenyi Prodigy platform. Delivered filter integrity strategy, process improvement initiatives, SOPs and change control documentation to support GMP operations.
Drug product technical SME through PPQ campaign execution and commercial launch readiness for a subcutaneous biologic. Delivered batch record review, stability and shelf-life planning, and cross-functional CMC coordination ahead of commercial filing.
CMC technical oversight on a biosimilar drug product programme at a European CDMO, including CMO evaluation, process fit assessment, RFQ development, and ongoing technical governance. Delivered as an independent outside-IR35 engagement.
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