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CDMO services for APIs: from clinical supply to commercial scale
Pharmaceuticals

CDMO services for APIs: from clinical supply to commercial scale

Novasep CDMO Services For API banner

Pharmaceutical innovators are today relying more & more on CDMOs (Contract Development and Manufacturing Organization) for the clinical & commercial production of their API (active pharmaceutical ingredient). Working with CDMOs allows drug companies to benefit from a long-term partnership with an experienced team offering specific skills, equipment and technical resources that are not available internally, resulting in a robust supply chain, reduced risks and optimized costs
But selecting the right supplier for a particular project is not always straightforward.

Here are some key considerations when choosing a CDMO partner:

 
Novasep provides flexible CDMO services for APIs & intermediates to innovators at a comprehensive range of production scales.

A recognized expertise in CDMO services

We offer specialized technologies, process development expertise and an outstanding regulatory track record.

Expertise in specialized technologies

Strength of process chemistry 

  • Strong expertise in DoE to increase process robustness & accelerate timelines
  • Over 90 process steps transferred from R&D to manufacturing per year

Flexible and collaborative approach

Outstanding quality assurance track record

  • Facilities inspected by European, Japan and US authorities
  • 9 Customer Products Manufactured by Novasep received FDA approval in the last 3 years
    To discover our full regulatory track record, download our brochure!

Customized engineering solutions

  • Possibility to offer bespoke manufacturing solutions on our sites

Multi-site API manufacturing capabilities

  • A strong, flexible manufacturing network for APIs with complementary technologies and a proven track record

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

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

Novasep Award Transparent Logo Top Pharma Outsourcing Companies In Europe 2021

Our CDMO services

Novasep offers a full range of CDMO services for APIs, from clinical supply to commercial scale manufacturing.

Process development services

More than 30 years experience of delivering robust commercial processes and full regulatory compliance.

Novasep CMDO Services Photo

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

Manufacturing services

  

Our facilities dedicated to CDMO Services

6 of our sites are experienced with APIs manufacturing:

  • Our Chasse-Sur-Rhône site, located in France, offers best-in-class CDMO services for APIs. The site has an excellent regulatory track-record with regular inspections by both the FDA & European authorities.
    Novasep Chasse Sur Rhône Site Photo

 

  • Our Le Mans site, located in France, benefits from more than 30 years of experience in HPAPIs and industrial chromatography. The site also offers a full and flexible range of ADC manufacturing services with hand-run experience on different conjugation platforms.
    Novasep Le Mans Site 2

  • Our Leverkusen site, located near Cologne in Germany, was founded almost 150 years ago by Alfred Nobel, and is Novasep’s center of excellence for hazardous chemistry. The site has an excellent regulatory track-record and is also ISO 9001 and ISO 50001 certified.
    Novasep Leverkusen Site Photo
  • Our Mourenx site, located in France, has over 40 years of experience in large scale API manufacturing & benefits from an excellent regulatory history. The site is home to Novasep's largest facilities for continuous industrial chromatography.
    Novasep Mourenx Site Photo
  • Our Pompey site, located in France, is Novasep's center of excellence for chromatography. The site offers CDMO services concerning the purification of APIs, cGMP intermediates & biomolecules from process development to commercial supply.
    Novasep Pompey Site Photo

  • Our Boothwyn (PA) site is the headquarters & R&D center of Novasep in the USA.This facility offers screening, process development and scale-up services for purification.
    Novasep Boothwyn Site Photo

 

Our latest investments for CDMO services

Upgrade of an API manufacturing facility (6,1M€)

Extension of HPAPI manufacturing capabilities (4M€)

Upgrade of an API manufacturing workshop (6,5M€)

  • Increase flexibility and capacity for low to medium volume APIs
  • 2 new synthesis reactors
  • Fully operational by Q4 2021
  • Chasse-sur-Rhône, France
    Learn more about this investment 

Extension of an API workshop (4,5M€)

  • New Hastelloy filter dryer (1,5 m²)
  • New clean room for Potent API (OEL >1mg/m³/8hrs)
  • Up to 350 kg per batch
  • Fully operational since 2019
  • Chasse-sur-Rhône, France
    Learn more about this investment 
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...
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