API Process Development & Manufacturing

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Route scouting

The selection of the right synthesis route is a key factor to ensure successful development and scale-up across project phases to supply program requirements for API.

Our state-of-the-art laboratories are fully equipped for a fast and efficient route evaluation, selection and scale-up for all kind of chemistries (high and low temperature reactions, flow chemistry, chiral molecules and many others). NUVISAN’s highly experienced scientists are accustomed to focus on robustness, effectiveness, high-throughput, purity profile, scalability, and safety of complex and multi-step chemical processes. As our client you benefit from our expertise at all points of the chemical development of your API, from early project de-risking to late-stage route scouting.

Process Development

Process Development starts from lab-scale process evaluation through, safety and scalability analysis, process optimization, purification development, and solid-state analyses. Our scientific team has extensive knowledge in the development of chemical processes, with a strong focus on solid phase characterization and impurity profiling. NUVISAN offers a full range of chemical development and pre-clinical chemistry services for the early-phase supply of drug substances.

Tox batch manufacture

Our fully integrated services from process development to non-clinical and clinical batch production ensures 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.

Highly potent API

We can 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 under GMP : Dedicated secured areas with breathable air and single use glassware depending on quantity.

Solid phase investigation

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.

GMP manufacture

Advance your candidate from non-clinical through Phase 1 clinical studies by scaling up in NUVISAN’s cGMP Kilo Lab. Our state-of-the-art cGMP facilities, with 266 Liters total capacity in 200 m2 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 package from NUVISAN enables straightforward transfer to a CMO to produce larger batches of your API. NUVISAN can also produce for you the radiolabelled API under GMP.

 

Internal standard synthesis

NUVISAN’s highly experienced scientists can help you to synthetize your internal standard (2H, 13C).
Please consult us.

Impurities identification

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)

Package from g to kg

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NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management