HPAIs Expertise: Handling, Synthesis & Purification

Synthesis Services and Purification Processes for HPAIs

 
The manufacturing of highly potent APIs demands a specialised approach, with the requirement to utilise high-containment manufacturing units in order to ensure maximum efforts for hygiene and isolated production conditions.

Novasep develops processes and chemical routes for Highly Potent molecules.

 

Novasep has a twenty year track record of success in highly potent multipurpose chemistry and purification by preparative chromatography.

For example, Novasep is the leader in synthesis and purification of Taxanes, among many other molecules.

Novasep Synthesis, at its site in Le Mans (France), is also a leading developer and producer of a range of HPAIs, such as Cytotoxics (Paclitaxel).

Novasep's HPAI Expertise

Novasep's background and expertise in early-stage services, pilot production (clinical quantities) and industrial production (commercial supply) of HPAIs, associated with a state-of-the-art quality system makes Novasep Synthesis a very reliable partner for its customers.

Our expertise in HPAIs includes process development and scale-up using kilo-labs and larger production means in a cGMP-compliant environment. Novasep offers the ability to scale-up highly potent ingredients projects as these pass the development phases.

Technologies:

Novasep Synthesis offers access to a wide range of technologies in its FDA inspected facility:

• Synthesis, hemi-synthesis, complex multi-step syntheses
• Highly potent drugs handling (Cytotoxic and non-cytotoxic)
• Hemisynthesis (taxanes, others)
• Heterocyclic chemistry (N,S,O mono or polycondensed ring systems)
• Automated preparative Chromatography
• Crystallization (polymorphism, solvates)
• Drug vectorisation: peptides, ADC intermediates

Special Safety Skills

• Ability to handle a broad range of highly potent chemicals
• Specific installations & equipment to operate processes using Highly Potent chemicals
• Toxicology and Industrial Hygiene management system
• Containment under OEB 5
• Extensive safety testing and training

In our facility at Le Mans, the highly potent handling constraints are embedded into our culture, behaviours, processes, personal regular trainings, to make the facility a cutting-edge company, handling highly potent molecules in terms of environment and industrial hygiene.

Combination/Integration

Novasep has the ability to combine techniques such as synthesis and hemi synthesis, preparative chromatography, crystallization and containments for HPAPI under OEB 5 at any scale.

Regulatory Support

On top of this HPAI chemistry and purification know how, Novasep brings in its expertise in Regulatory Affairs to propose to its customers the most efficient strategy for EU and US DMF filling.

This combination of synthesis and industrial chromatography expertise in the field of HPAIs has provided Novasep with a unique set of integrated technologies, for our customers' benefit.

Mixing proven chemistry to innovative purification technologies for Highly Potent API makes Novasep offering unique. We can introduce at the right step, a preparative chromatography purification to simplify and reduce the number of synthesis steps in order to obtain pure and economically advantageous Highly Potent APIs.

Benefits & Advantages

Capacity

To meet an increasing demand for multipurpose chemistry and purification in confined areas for highly potent molecules, Novasep has the capacity to:

• offer 2 cGMP highly potent kilo-labs and 3 industrial suites including large scale chromatography, up to OEB5,
• scale-up highly potent ingredient projects as they pass the development phases,
• offer process and analytical development, as well as regulatory support and DMF filing,
• produce early clinical phase quantities under cGMP,
• move customer's projects forward to the industrial stage in a certified facility.

Differentiation

When timing, cost, quality and capabilities are just not enough, Novasep builds its special partnering services offering by understanding the customers' challenges.

Big, mid sized and emerging pharma companies share the same needs for quantity, quality and timeline but their challenges are different and depend on their business model. Novasep understands these challenges and adapts to address these with high priority.

Color: Green !

Novasep has developed a third generation process for the production of Paclitaxel, positioning Novasep as the world most experienced and the largest semi synthetic Paclitaxel supplier. This new process is economically and environmentally advantageous. It requires an extremely low level of solvent consumption, and necessitates very small quantities of raw material. These features are a definitive breakthrough towards world class green chemistry, planet protection and this is part of Novasep's sustainable development concern.

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