Biosimilar Programmes — Manufacturer & Supplier

Development-stage support for biosimilar programmes — formulation, fill-finish engineering batches, analytical comparability and stability.

This is deliberately described as programme support rather than product supply. We do not hold biosimilar marketing authorisations and do not present any biosimilar as a finished licensed product. What we offer is the development and fill-finish capability a programme needs between drug substance and a regulatory submission. That means formulation and excipient screening for aggregation and oxidation, engineering and clinical-supply batches in vials or pre-filled syringes under cold-chain control, analytical comparability support — SEC, CEX, CE-SDS, peptide mapping and potency by cell-based or binding assay through qualified partner labs where required — and ICH-compliant accelerated and long-term stability with photostability per Q1B. Sponsors retain all process knowledge, cell line rights and analytical data. We work to the sponsor's protocol and hand back a documented transfer package. Listed formulations describe manufacturing capability and qualified facility scope. They are not an offer of approved or marketed products, and any supply is subject to the customer holding the applicable marketing authorisation for the destination market.

Manufactured under the Stancor Pharma brand by Stancor Pharma.