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API development services

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 As a pharmaceutical innovator, manufacturing your new API may seem both complex and challenging. You will need expertise for developing and optimizing a robust, transferable, and scalable process to support long-term production.

Novasep can bring its extensive process development experience to your drug substance from technical and analytical transfer to process optimization and validation. We offer a full range of CDMO services for your APIs, with an emphasis on quality, speed, and flexibility.

A demonstrable expertise in API process development and scale-up

Novasep has been offering CDMO development & manufacturing services for APIs for more than 30 years.

With more than 50 process steps transferred from R&D to manufacturing each year, Novasep is recognized for its process development know-how. Our strong expertise in DoE (Design of Experiments) enables to increase process robustness, to ease production scale-up and therefore accelerate timelines to answer your needs.

Novasep API Development

An extensive toolbox of technologies coupled with our strength in process chemistry, allows our teams to develop and implement innovative new generation processes, enabling us to extend product lifecycles.

 

Discover the top 6 reasons why customers choose Novasep as a CDMO partner:

Top 6 Reasons Why Customers Choose Novasep As A CDMO Partner Thumbnail

Did you know? Novasep has been recognized as one of the Top Pharma Outsourcing companies in Europe in 2021:

 

Novasep Award Top Pharma Outsourcing Companies In Europe 2021Our CDMO services for API development 

From the production of the first grams of your small molecule drug substance to several kilos, Novasep offers a full range of early phase process development and scale-up services for APIs. We can combine innovative synthesis and purification to design more efficient processes to add value and increase capacity.

Novasep API Manufacturing Services

Process development to scale up

  • Technical transfer
  • Process development & scale-up
  • Analytical methods development and optimization
  • Process safety assessments

"Novasep’s experts helped us a lot to overcome technical problems in the process over the past few years", Big pharma

Process Validation

  • Validation of analytical methods
  • Validation of equipment cleaning methods
  • Regulatory support (lien vers page dédiée)
  • Validation of manufacturing process
  • Preparation of validation report

Novasep provides services all along your API journey, to routine commercial production.

Novasep API Process Development


Find out more about our process development expertise and approach for APIs by downloading our dedicated posters:

Novasep Poster Icon

Process safety assessment

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Process modeling

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Statistical tools for process development

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Impurities management along the process development lifecycle

 

Our facilities for API development 

Our network of 6 sites, at the heart of Europe and in the U.S., is strongly supported by a team of committed chemistry professionals.

 

Novasep CDMO Sites in Europe

 

Sites

 Process development

 Kilolab manufacturing

 Pilot manufacturing

 Process validation

Chasse-sur-Rhône, FR

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Le Mans, FR

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Mourenx, FR

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Pompey, FR

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Leverkusen, DE

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Boothwyn, US

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Novasep offers purification development services from its Pompey & Chasse-sur-Rhone facilities in France, and its Boothwyn site in the USA, including screening & process development using Novasep’s designed preparative chromatography technology. 

Novasep Process Development Site Boothwyn


Our Leverkusen site develops processes including hazardous chemistry steps.

In addition, Novasep's Le Mans site in France supports the early phase development of HPAPIs & cytotoxics as well as Antibody Drug Conjugates (ADCs). The site combines synthesis and HPLC chromatography of Band 4 compounds (Safebridge®). 

Our facilities are closely connected and benefit from shared resources for Project Management or R&D.

All our sites have been recently inspected by the National Authorities and the FDA: learn more about our excellent regulatory history in our Pharma brochure.

Pharma Novasep Brochure Front Cover 2020

Download our Pharma CDMO brochure

 

Downloads
  • 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...
  • 原薬CDMOサービス
    原薬CDMOサービス
    Novasep provides flexible development and manufacturing solutions for small molecules APIs and advan...
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