Services
A development partner from concept to GMP
We support specialized-modality programmes from first feasibility through GMP manufacturing. Engage us for a single feasibility study, a conjugation or format-engineering campaign, or an integrated programme that carries your molecule from concept to GMP drug substance and drug product.
The journey
Four stages, concept to GMP
Feasibility & developability
Conjugation/format options, a risk map and a recommended route. Input: antibody/sequence + target profile.
Conjugation / format engineering
A conjugation chemistry or engineered format with DAR and identity data. Input: research-grade material.
Scale-up & analytics
A scalable process, analytical package, stability and comparability. Input: confirmed conjugate or format.
GMP drug substance & product
Contained GMP manufacture, release testing and clinical supply. Input: transferable process.
Engagements can start at any stage. The numbered stages indicate where each service sits on the path from concept to GMP; programmes are scoped to conserve material and protect timelines.
From concept to GMP conjugate
Our integrated programme brings feasibility, conjugation or format engineering, scale-up, analytics and GMP supply under one team and one timeline. We start by confirming the modality can be made and characterised, engineer the chemistry or format, then scale it into a contained GMP process.
The output is a manufacturable conjugate or engineered antibody with a defined analytical package and a coherent CMC and regulatory narrative — the control strategy a complex modality needs to progress with confidence into the clinic.
Discuss your programmeHow we engage
Flexible by design
Feasibility study
A fixed-scope study to answer one question: can this conjugate or engineered format be made, characterised and controlled? Fast, candid and material-sparing.
Development-to-GMP programme
End-to-end development with defined stage-gates, from conjugation or format engineering through scale-up to contained GMP drug substance and drug product.
Advisory & CMC support
Independent assessment of a conjugation or format strategy, control-strategy and comparability input, and targeted troubleshooting for DAR, aggregation or stability problems.
Scope a programme with us
Tell us where your modality is today and we'll propose the most material-efficient route to a contained, GMP-ready process.