Fee-for-service and independent of GMP manufacturing. Our recommendations answer to your molecule, not to a facility.
You arrived with a challenge, not a service code. Six of the most common are below.
Your lead isn’t stable, or it’s degrading
High concentration feels like a black box
Shorten the cycle, or go elsewhere
Which of your leads is actually developable?
Your first GMP batch is out of spec
Can we survive a change in manufacturer?
Every stage change asks something new of the formulation and the process. We work out what keeps your API stable in its matrix, and what.
The only formulation specialist covering ADCs and cytotoxics independently of a fill site.
Last week’s results change this week’s plan? Fine. That’s the work.
You talk to the people running the experiments. One PM, one lead engineer.
Most clients meet us at one phase change and come back at the next.
Six service areas. Fixed-price work packages, defined go/no-go points, report-outs and hand-offs.
QbD DoEs for liquid, frozen and lyophilised APIs.
Cycles designed, optimised, troubleshot. Manufacturer-friendly by design.
Scale-up, manufacturability and process simulation, before the transfer.
Chromatography, mass spec, particulates. Molecule-appropriate instruments.
Accelerated, real-time and forced stress studies, ICH-compliant.
Pilot-scale tox and stability batches, ADCs and cytotoxics included.
Top 5 Pharma · on ADCs and large molecules
Didn’t find your question? Conversations and quotes are always free.
Our calls veer technical fast, usually more useful than another month of internal debate. If we’re not the right partner, we’ll say so.
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82152 Martinsried, Munich
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