Pharmaceutical process development

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Novasep Process: Pharmaceutical Process Development

Experience Counts

Novasep Process has developed 100's of purification processes for pharmaceuticals, fine chemicals, cosmetic and food ingredients including:

  • Fine chemicals, synthetic intermediates and APIs
    - Chiral separations
    - Isolation of molecules from complex reaction mixtures
    - Purification of synthetic peptides
  • Purification of natural extracts

A Unique Pool of Technologies and Know-how

 

Batch technologies

Continuous Technologies

Preparative HPLC: Hipersep®, Cyclojet®

Continuous chromatography: SMB, Varicol®

Supercritical fluid chromatography (SFC): Supersep

Ultrafiltration, nanofiltration

Proprietary modelling software

Crystallization (batch and continuous)

Evaporation and solvent recycling

Process development is accelerated through the use of our proprietary modelling software. Novasep Process answers your evolving needs, e.g. using batch processes (crystallization, HPLC and SFC) to reduce time to market, and continuous processes (Varicol®, continuous crystallization) to optimise commercial production costs.

A Comprehensive Range of Services

Your Goals:

Our Offer:

- A reliable dedicated partner

  • Confidentiality agreement
  • Highly skilled staff with 100s of years of combined experience
  • Product-related developments owned by customer

- Quick feasibility statement

  • Screening
  • Fixed fee

- Optimised and robust purification process

- Early budget costing for large scale purification

  • Process development and optimisation (modelling & simulation)
  • Computer modelling and simulation

- Pure product for evaluation

  • Proof of concept and pilot demonstration

- Pure product for pre-clinical to phase III tests

  • Scale-up
  • cGMP purification of intermediates and APIs, from grams to tons

- Performance guarantees

- Firm price for custom purification services and/or systems

  • Robustness studies
  • Service and/or system commercial proposal

- Process validation support

  • Full supporting data for process validation

Benefits and Advantages

Novasep Process development solutions challenge industry standards

Through our expertise in crystallization:

  • We integrate polymorphism studies, optimise crystal shape, particle size distribution.
  • We master "the solid chain", from crystallization through to the downstream processes such as filtration, drying, milling, granulation.

With our multidisciplinary team of chemical engineers, biochemists and chemists:

  • We combine processes: chromatography, extraction, membranes, crystallization, drying
  • We integrate evaporation and solvent recycling to develop green processes

Through project-based collaboration with Novasep Synthesis:

  • We assist chemical development: design of multi-step organic syntheses including separation step(s), racemization of non desired enantiomer for chiral syntheses, etc.
  • We synthesise and purify Highly Potent Active Ingredients (HPAIs).

Browse our pharmaceutical applications

Download our chromatography brochures

Contact us for pharmaceutical purification/separation