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Service Offering
Engage us for a single workstream or hand over the whole program. Because development and manufacturing sit under one roof, what we learn at the bench moves cleanly into the plant — no re-discovery, no surprises at scale.
Capability matrix
| Service | What it delivers | Scale | Stage |
|---|---|---|---|
| Strain development | Host selection, clone screening, codon & promoter engineering, research and master cell banking. | — | Pre-clinical |
| Process development & scale-up | DoE fed-batch optimization, refold development, downstream design, scale-down qualification, tech transfer. | 5 L – 200 L | Pre-clinical → clinical |
| Drug substance manufacturing | GMP fermentation, harvest, recovery, purification and bulk fill of microbial drug substance. | 300 L – 25,000 L | Clinical → commercial |
| Analytical development | Method development & validation, characterization, impurity assays, release and stability testing. | — | All stages |
| Drug product & fill | Formulation development, lyophilization, aseptic vial/syringe fill-finish, stability. | up to 120k vials | Clinical → commercial |
| Regulatory & CMC | CMC strategy, dossier authoring, IND/IMPD & BLA/MAA support, comparability, process validation. | — | All stages |
In detail
We start from your sequence and a target product profile, then build and screen construct libraries across our host toolbox.
Fed-batch and downstream are co-developed using DoE, then locked against a calibrated scale-down model.
GMP suites run single-use and stainless fermentation with integrated downstream recovery and purification.
Phase-appropriate methods that grow with your program from first-in-human through validation.
From formulation screening to a finished, labeled product ready for the clinic or market.
Regulatory thinking is embedded from day one so the dossier writes itself as the program runs.
Engagement
A discrete deliverable — a refold screen, a method validation, a single GMP campaign — scoped, priced and run to a fixed milestone.
We carry the molecule from process development through clinical drug substance, owning the tech transfer between them.
Full lifecycle ownership from strain to commercial launch, with dedicated program management and a shared launch plan.
Scope a program
A single milestone or the whole journey — we'll scope it and give you a realistic plan and timeline.