Exclusive Synthesis: Clinical Quantities

Exclusive Synthesis for Clinical Quantities

Novasep supplies services to pharmaceutical industries that need their drug candidates at clinical stage manufactured under cGMP standards. We deliver these molecules at their highest purity level ready for clinical trials.

Developing synthesis routes for API candidates during their clinical development phase represents major challenges, one of them being to meet time constraints. With its teams of highly skilled and experienced chemists and process engineers, Novasep has proven over the years to be an essential partner in reducing delivery time and in developing innovative means to produce molecules. Our process development teams have successfully demonstrated their capacity to integrate numerous multi-step projects (up to 400 chemical steps are scaled up per year).

Novasep's Offering for Clinical Supply

Novasep provides cGMP synthesis of Active Pharmaceutical Ingredients and intermediates for clinical supply.

Novasep clinical supply services include:

• cGMP synthesis of API candidates
• Regulatory support (DMFs)
• Analytical validation and support (impurity characterization, stability testing, quality control support, ...)
• ICH Stability
• Project management (formal and continuous flow of information).

Our Clinical Supply Team

Novasep's clinical supply team is composed of expert chemists and process engineers, experienced with the demands of clinical phase projects.

Our specialist teams have developed numerous chemical processes & synthesis routes, having the capacity to integrate multi-step projects. Our chemists and project managers interact and communicate directly and regularly with our customers.

Novasep's Technologies

Clinical supply services are using Novasep's technology portfolio:

• Chiral technologies: asymmetric synthesis, chiral pool, preparative chiral chromatography,
• Hazardous chemistry: azide, diazomethane, diborane, ozonolysis, carbonylation
• Synthesis and purification of HPAIs (highly potent active ingredients) under OEB 5
• Multi-step synthesis

Benefits & Advantages

The benefits of working with Novasep Clinical Supply Services are:

• Your access to Novasep's full range of technologies and capabilities,
• Our capacities to:
  • to free the customers' internal resources to focus on their core business
  • to work under cGMP, in certified facilities,
  • to scale-up and partner throughout the life cycle of drug candidates,
  • to design optimal chemical routes
• Direct and regular communication with our chemists,
• Regular reporting system according to your requests,
• Dedication of the required resources to bring the project to the next step on time,
• Project management to ensure communication to guarantee transparency and to deal with the project with high priority.