Non-GMP Manufacturing

Non-GMP Manufacturing

Specialized infrastructure & expert teams for safe, compliant development & manufacture of high-potency APIs, including for oncology.

Overview

We provide end-to-end HPAPI services from early route identification through commercial-scale cGMP supply. Our facilities include multiple dedicated HPAPI suites (OEL / OEB compliance), isolator technology, enriched analytical lab support, and a robust payload/linker library. We support both oncology & non-oncology high potency compounds.

3. Non-GMP Manufacturing

Purpose & What We Do

•Provide early-stage supply (preclinical, toxicity, proof of concept) under non-GMP or GLP-like conditions
•Facilitate faster turnaround for screening, animal studies, or early toxicology batches without full regulatory GMP overhead

Key Activities

•Small batch non-GMP production with containment suited to high potency materials
•Early analytical release and purity testing (non-clinical standard)
•Stability, degradation, preliminary safety profiling

Deliverables

•Non-GMP / GLP-like material for preclinical / tox studies
•Characterization data: purity, identity, major impurity profile, particle size / aerosolization (if applicable)
•Safety documentation for handling & transport

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