Novasep

About Novasep

Novasep provides flexible contract development & manufacturing (CDMO) solutions for Small Molecule APIs to innovators. We offer a wide range of flexible cGMP manufacturing assets on multiple sites with an outstanding regulatory track record.
We are a world leader in a number of technologies including HPAPIs, ADCs, hazardous & cryogenic chemistry, industrial chromatography (batch and continuous).

Novasep has recently invested over 20M€ to expand its commercial manufacturing footprint including:
> APIs: A 6,5M€ expansion of a manufacturing workshop in Chasse-sur-Rhône, France
> APIs: A new 4M€ cGMP cryogenic production line in Chasse-sur-Rhône, France
> ADCs: A new 12M€ bioconjugation unit in Le Mans, France

  • FR
  • 2015
    On CPhI since
  • 1000 - 4999
    Employees
Manufacturer/Innovator
Contact info

Products from Novasep

  • CDMO services for APIs

    Product CDMO services for APIs

    With more than 50 years experience, Novasep offers a full range of CDMO services for APIs, from clinical supply to commercial scale manufacturing:

    Process development services
    • Technical transfer
    • Process development & scale-up
    • Development, optimization and validation of analytical methods
    • Process validation
    • Safety assessments
    • Regulatory support
    • ICH stability studies

    Manufacturing services
    • 5 FDA inspected API sites
    • More than 40 commercial APIs & advanced intermediates
    • From Kg-lab and pilot to full commercial scale
    • A wide range of reactor trains from 100L to 15m3 scale
  • CDMO services for ADCs

    Product CDMO services for ADCs

    Novasep offers a full range of CDMO services for ADCs, from process development to cGMP production:
    Fast track offer for preclinical studies
    - From 1mg to 100mg ADC sample
    - Platform analytical methods
    - 6 weeks turnaround time

    Phase I package
    - From 100g to 500g cGMP scale 
    - Process and analytical development
    - Stability studies

    Clinical and validation package
    - Process and analytical validation
    - Registration batches
    - BLA regulatory support

    Custom package
  • CDMO services for ADC payloads

    Product CDMO services for ADC payloads

    Novasep offers a full range of ADC payloads manufacturing services, from process development to cGMP production:

    R&D laboratories
    • Analytical & process transfer / Familiarization
    • Process & analytical development
    • Process characterization
    • DoE – Design of Experiments
    • Batch size: Up to 10g

    Kilolabs
    • cGMP production for clinical trials
    • Process validation
    • cGMP production for commercial supply
    • Batch size: Up to 500g

    Large-scale production
    • cGMP production for clinical trials
    • Process validation
    • cGMP for commercial supply
    • Batch size: Up to 1kg

    Quality control
    • Method development, transfer and validation
    • IPC
    • Release testing
    • Stability studies
  • CDMO services for HPAPIs

    Product CDMO services for HPAPIs

    Novasep offers a full range of CDMO services for HPAPIs from process development to cGMP production.
    Our Le Mans site is equipped to handle compounds with an OEL below 30 ng/m³/8hrs and a maximum batch size of 10 kgs.

    Process development
    • Transfer and continuous improvement of established processes
    • Development & scale-up of new processes
    • Development, optimization and validation of analytical methods
    • Safety assessments

    Kilolabs & Large-scale production

    • cGMP production for clinical trials
    • Process validation
    • Commercial supply

    Quality control
    • Method development / transfer / validation
    • IPC
    • Release testing
    • ICH Stability studies
    • Regulatory support
  • CDMO purification services

    Product CDMO purification services

    Novasep offers a wide range of cGMP CDMO manufacturing services using chromatography, from process development & clinical supply to commercial manufacturing. 
    We offer both batch & continuous chromatography at scales from 10’s of grams to 100’s tons per year.

    From feasibility studies to process validation and qualification, we offer customized solutions to design, develop and optimize your chromatography process:

    • Screening
    • Process Development study
    • Proof of Concept (POC) study
    • Scale-up and Technical batch
    • Manufacturing of cGMP batches
    • Validation
  • CDMO services for biomolecules purification

    Product CDMO services for biomolecules purification

    Novasep offers a wide range of CDMO services for your biomolecules (e.g. plant extracts, animal extracts, fermentation broth, …) from process development to manufacturing:
    • Process development
    • Scale-up
    • Contract manufacturing (clinical & commercial supply)

  • CDMO services for Fine chemicals

    Product CDMO services for Fine chemicals

    Novasep offers a full range of custom manufacturing services from development, pilot production to commercial scale manufacturing of fine chemicals:

    Process development
    • Familiarization study
    • Safety studies
    • Heat and mass transfer balance
    • Kinetics
    • Side reactions
    • Critical parameters

    Custom manufacturing
    • Multi-step synthesis from kg to hundred-ton scale
    • Best possible pricing for raw materials


    Contract purification

    Novasep is an expert in advanced purification technologies at industrial scale. We can develop a chromatography process to purify your products and guarantee the performance and cost-efficiency at full production scale from gram-scale laboratory trials


    Products catalog

    Novasep proposes a wide range of products for various fine chemical markets.
  • CDMO services for Agrochemicals

    Product CDMO services for Agrochemicals

    Novasep offers CDMO services for Agrochemicals active ingredients and intermediates from process development to industrial manufacturing:
    • Process development
    • Scale-up
    • Contract manufacturing (up to several thousand tons)


  • CDMO services for generic APIs

    Product CDMO services for generic APIs

    Novasep produces several generic APIs and intermediates:

    Pre-formulated nitroglycerin

    Novasep manufactures and sells a wide range of cGMP pre-formulated nitroglycerin. We can provide you with customized formulations meeting your specifications and production needs.

    Omega 3

    Novasep proposes unique cGMP manufacturing services for omega-3 and other poly-unsaturated fatty acids from pilot- to very large-scale. We have an extensive experience handling and purifying omega-3 from various biomass sources including fish oil, algae, etc.


  • Hazardous chemistry

    Product Hazardous chemistry

    Novasep offers a full range of hazardous chemistry services for APIs, from process development to industrial scale manufacturing:

    Early development
    • Hazard evaluation studies
    • Route scouting

    Process development to scale-up
    • Process development
    • POC study
    • Risk analysis
    • Scale-up & technical batches
    • Manufacturing of cGMP batches

    Validation
    • Process validation
    • Analytical validation
    • Cleaning validation
    • Life-time study
    • Regulatory support

    Commercial manufacturing
    • Routine production
    • Continuous improvement
    • Life cycle management

Novasep Resources