GMP Batch Manufacturing
Our fully integrated services from process development to non-clinical and clinical batch production ensure a fast and efficient delivery of your drug substance. Process development and kilogram batch manufacturing are performed on the same site by our highly flexible and qualified team of scientists to ensure that non-clinical supplies can be delivered at the appropriate time, and to speed up and reduce the costs of your clinical supplies. Batches from 1 to 10 kg of your intermediate or API can be produced in our kilo-lab with a control of the impurities to ensure successful pre-clinical studies.
Advance your candidate from non-clinical through Phase 1 clinical studies by scaling-up in NUVISAN’s GMP Kilo Lab. Our state-of-the-art GMP facilities, with 266 liters total capacity in 200m2 allows the production of kg batches for clinical studies. This work includes analytical method validation, CoA with specifications, PGI assessments. The batch records and technical packages from NUVISAN enable straightforward transfer to a CMO to produce larger batches of your API. NUVISAN can also produce radiolabeled APIs under GMP.
We can also handle and manufacture from the lab to kilo-lab highly potent compounds until HHB5 (OEL >0.1 µg/m3). Safe, Highly Potent API process development can be performed in our lab thanks to tailor made closed filters, tailor made powder introducers for charging reactors, and dedicated secured areas with breathable air. Highly Potent API manufacturing under GMP is also available. Dedicated secured areas including breathable air and single use glassware are available.
Solid Phase Investigations
NUVISAN’s highly experienced scientists can readily help you to select and control the solid state of your API. NUVISAN performs solid state investigations of small organic molecules to identify new solid forms such as polymorphs, salts, co-crystals or amorphous forms. These studies allow a better understanding of the solid state of your intermediate or your API.
Impurities Identification & Development
Identification and structural elucidation of impurities represents a frequent task in process development. NUVISAN’s highly experienced scientists can isolate, identify, synthesize and assess unknown impurities present at levels higher than allowed by ICH legislation (0.1 %). Our chemists can identify degradation pathways, and potential ingredient interactions that will facilitate the examination of the dossier by regulatory agencies. Following the impurity identification, NUVISAN also offers a toxicological evaluation on the impurities when needed. These services include but are not limited to literature search for non-clinical safety evaluation on ingredients (Pharmaceutical; Cosmetic: Margin of Security determination):
- Chemical risk assessment (OEL and OHB classification, MSDS)
- PDE assessment for medicinal product (EMA guidelines 2015)
- Impurity safety assessment and qualification strategy (ICH Q3)
- Consulting for gap analysis, preclinical development plan and monitoring of toxicology studies (screening and GLP)
Infographic