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Hazardous chemistry: from process development to large scale production

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Hazardous chemistry, involving the use of highly energetic reactions and/or hazardous reagents, is a key technology in the process development toolbox, with potential to improve process cycle time, purity & yield, reducing both operational costs and environmental impact. Its use is well established for the commercial synthesis of APIs & intermediates, and offered by specialist CDMOs such as Novasep, with a strong safety culture & benefitting from decades of expertise.

In some cases, the innovative use of hazardous chemistry can contribute to a significant reduction in the number of synthesis steps. The amount of impurities and by-product generated may also be limited leading to cost-effective syntheses affording the targeted compound in high yields.

Novasep offers a full range of hazardous chemistry services for APIs:

Novasep Hazardous Chemistry Leaflet

Download our Hazardous Chemistry leaflet to learn more!

A recognized expertise in hazardous chemistry

Novasep is a world leader in the production of hazardous compounds. We have a proven track-record in developing and manufacturing APIs using hazardous chemistry:

Over 35 years of experience in commercial manufacturing

  • Manufacture of APIs & cGMP intermediates using hazardous chemistry
  • More than 20 APIs produced every year

Outstanding quality assurance track record

  • Facilities inspected by the US FDA, National Health Authorities (EU) and PMDA (Japan) accredited: download our brochure about CDMO services for APIs to learn more! 

Depth of HSE culture & know-how

  • Deeply ingrained safety culture
  • Excellent HSE track record 
  • Methodology for risk analysis
  • On-site safety testing 
  • Authorisation for explosives manufacture on our Leverkusen site

Expertise in hazardous chemistry legislation

  • Hazard evaluation and knowledge of regulations
  • Reports accepted by authorities (REACH BAM, BZR)
  • Ability to offer regulatory support to our customers

Support for freight & logistics of dangerous goods 

  • Dangerous goods classifications
  • Expertise and support with transport

Strength of hazardous chemistry process development 

  • Process development expertise with a wide range of highly energetic reactions and compounds
  • Wide experience with process scale-up, validation & commercial production at a wide range of scales 

Flexible and collaborative approach

  • Experienced Project Managers
  • Reactive to changes in customer needs

Novasep Expertise In Hazardous Chemistry

Our specific know-how in hazardous chemistry 

We have specific expertise in handling:

  • Explosive compounds
  • Shock & friction sensitive chemicals such as Nitroglycerin
  • Self-igniting gases and liquids
  • Thermally sensitive compounds
  • Toxic materials
  • Highly exothermic reactions

We are experienced in highly hazardous chemistry such as:

Our expertise also includes:

  • Alkyllithium handling
  • Hydroxylamine chemistry
  • Sodium metal handling
  • Lithium aluminium hydride (and other hydrides) handling
  • Highly exothermic reactions 
  • The handling of explosive compounds
  • The handling of highly toxic materials and thermally/mechanically unstable 

Check out our case study about the development and manufacturing of a Phase III API using azide chemistry to learn more about our expertise.

Novasep Specific Expertise In Energetic Reactions

Our hazardous chemistry solutions 

Novasep offers a full range of hazardous chemistry services for APIs, from process development to industrial scale manufacturing. From kilogram to multi-ton commercial per year, you can rely on our expertise to produce your key intermediates or APIs in a safe and reliable way.

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

Download our hazardous chemistry services leaflet to discover what our customers say about our services! 

Safety expertise for handling hazardous reactions

The explosive nature of some reagents demands specific know-how, high safety standards, and strict process controls. We ensure supply security thanks to extensive safety testing, specific installation and isolated production units. 

Besides adequate manufacturing procedures, we provide sophisticated chemical safety testing:

  • Thermal stability: DSC, TGA, Koenen test, Bonfire test
  • Mechanical stability: shock and friction sensitiveness test
  • Tests for detonation propagation (2”-steel tube test)
  • Storage stability test
  • Tests for self-decomposing materials
  • Hartmann tube (dust explosion test)
  • Reaction calorimetry, heat balance calculation
  • Transport classification

Novasep hazardous chemical safety testing

Our 2 sites dedicated to hazardous reactions 

2 of our sites, located in Europe, are experienced with hazardous chemistry:

  • Our Leverkusen site, founded by Alfred Nobel & located in Germany, has almost 150 years of experience in energetic reactions. Our site has been successfully inspected by both the FDA & European authorities recently and is also ISO 9001 and ISO 50001 certified.

Novasep Manufacturing Facility For Hazardous Chemistry In Leverkusen

  • Our Chasse-sur-Rhône site, located in France, has more than 10 years of experience in Ozonolysis. The site has an excellent regulatory track-record with regular inspections by both the FDA & European authorities.

Novasep Manufacturing Facility For Ozonolysis In Chasse Sur Rhone

Our hazardous chemistry manufacturing capabilities 

To learn more about Novasep’s hazardous reactions capabilities, download our dedicated leaflet:

Novasep Hazardous Reactions Capabilities

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  • A full range of hazardous chemistry services for APIs
    A full range of hazardous chemistry services for APIs
    Learn more about Novasep's 35 years of experience in hazardous chemistry for the manufacture of APIs...
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  • A full range of CDMO services for APIs
    A full range of CDMO services for APIs
    Novasep provides flexible development and manufacturing solutions for small molecules APIs and advan...
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