Exclusive Synthesis: Early Stage Services

Early Stage Services-"Fast & Pure": keeping projects on the fast track.

Novasep's early stage services address the challenge to move active pharmaceutical ingredients from lead optimisation into clinical candidates. Especially during early stages of development, pharmaceutical companies all have the same needs: quantity, quality and time constraints. Novasep supports customers during preclinical and early clinical phases by providing fast access to pure molecules.

Novasep offers exclusive, custom synthesis services from milligram to kilogram.

Novasep's Early Stage Offering

Novasep offers its custom synthesis services to meet customers' needs for:

• synthesis and purification of preclinical batches of drug candidates for ADME TOX studies, stability, formulation, etc.
• cGMP synthesis of APIs for clinical trials .
• synthesis and purification of reference compounds, intermediates, analytical standards and metabolites
• Analytical methods development, stability testing including stress stability and regulatory support

Our Early Stage's Team

Novasep's Early Stage team is composed of experienced and expert chemists , who are familiar with the demands of early stage projects. Novasep specialists are handling different types of cGMP products and among those, highly potent APIs. All API manufacturing sites are FDA inspected.

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

Combined and Unique Solutions

Mixing proven chemistry to innovative purification technologies for early stage API candidates makes Novasep offering unique.

For example, our team will introduce, at the appropriate step, a preparative chromatography purification to simplify and speed up the synthesis route in order to obtain rapidly pure quantities of a required molecule. This brings obvious advantages such as being able to select the optimal synthesis stage for purifying the desired compound.

Novasep's Technologies

Early stage services are using Novasep' s technologies portfolio:

• Chiral technologies: asymmetric synthesis, chiral pool, preparative chiral chromatography,
• Hazardous chemistry: azide, diazomethane, diborane, ozonolysis, carbonylation
• HPAIs expertise : synthesis and purification of highly potent active ingredients under OEB 5
• Natural product isolation and semi-synthesis
• Drug vectorization
• Multi-step synthesis

Benefits & Advantages

The benefit of working with Novasep's early stage services are:

Purity

• Access to innovative technologies and chemistry
• Combination of synthesis and preparative chromatography
• Synthesis and purification of preclinical batches for ADME-tox, stability studies, formulation, etc...
• cGMP production of drug candidates for clinical trials
• State-of-the-art purification tools
• Ability to synthesize HPAI in a contained environment (OEL 0.1-5 µ g/m 3 )

Time

• Access to fast & pure synthesis and purification from milligrams to kilograms
• Reduce time to market
• Speed up your development process
• Selection of the optimal synthesis route

Reactivity

• Ability to scale up from lab to commercial scale
• Direct and regular communication /interaction between you and our chemists
• Regular reporting system according to your requests
• Innovation and flexibility through combination of preparative chromatography and chemistry
• Access to our in-house experts in chromatography, membranes, crystallization
• Strict confidentiality and respect of your IP and of the IP generated during our work
• Projects handled with our high standards of safety and environmental concern