Exclusive Synthesis - Commercial Supply

Novasep offers exclusive synthesis services to deliver commercial quantities of APIs (Active ingredients) to be launched in the pharmaceutical, cosmetics, agrochemical markets. These custom synthesis services combined with Novasep's process capabilities provide innovative and economically advantageous industrial solutions to customers.

Novasep's exclusive synthesis services extend from chemical route design, process development, process scale-up, process improvement, including alternative route development to large scale manufacturing in cGMP and FDA inspected facilities. Quality control and regulatory support are included in order to bring to Novasep's customers the solution they are looking for.

Novasep's Offering for Commercial Quantities

Novasep provides exclusive synthesis for commercial quantity of active ingredients. This service includes:

• cGMP manufacturing in FDA inspected facilities
• Chemical route design
• Process development and process scale-up capabilities
• Quality control support
• Regulatory support
• Experience in hazardous chemistry (Novasep is the largest cGMP manufacturer using Azide Chemistry)
• Experience in Highly potent synthesis and purification
• Experience in asymmetric technologies
• Experience in multi-ton multi-step synthesis

Our Commercial Supply Team

Novasep's clinical supply team is composed of experienced and expert chemists and process engineers, who are familiar with the demands of commercial APIs synthesis projects.

Novasep specialists are used to developing chemical processes & synthesis routes, and have the capacity to integrate numerous multi-step projects.

Our chemists and project managers interact and communicate directly and regularly with our customers.

Novasep's Technologies

Commercial 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 under OEB 5,
• Multi-step synthesis, multi-ton synthesis.

Benefits & Advantages

The benefits of partnering with Novasep exclusive synthesis services are:

• Your access to Novasep's technologies and capabilities
• Our ability to:
  • free customers' internal resources to focus on core business
  • work under cGMP, in certified facilities
  • scale-up and partner throughout the life-cycle of drug candidate
  • design optimal chemical routes
  • obtain an economically advantageous route
• Direct and regular communication between your teams and our chemists
• Regular reporting system according to your requests
• Dedication of required resources to bring the project to the next step on time
• Project management to ease the communication flow, to guarantee transparency and to give the project high priority.