Small molecule API manufacturing is a complex challenge requiring chemistry expertise as well as specialized facilities, regulatory experience & supply chain management.
That’s why pharmaceutical innovators are today relying more and more on CDMOs (Contract Development and Manufacturing Organizations) for the manufacturing of their API (Active Pharmaceutical Ingredient). Indeed, working with CDMOs allows drug companies to benefit from a long-term partnership with an experienced team offering specific skills, equipment, capabilities, and technical resources that are not available internally, resulting in a robust and secure supply chain, reducing risks and optimizing costs.
But selecting the best supplier for an API manufacturing project is not always straightforward.
Here are some of the key considerations when choosing a CDMO partner:
A reliable CDMO partner for API manufacturing
For more than 30 years, Novasep has been a leading CDMO in the API (Active Pharmaceutical Ingredient) arena capable of providing unique services for drug substance manufacturing, from clinical to commercial.
With an experienced team of chemists, Novasep:
- Manufactures more than 40 commercial APIs & advanced intermediates per year
- Transfers more than 50 process steps from R&D to manufacturing each year
- Offers its extensive validation experience: more than 10 customer products manufactured on our sites received FDA approval in the last 4 years
Did you know?
We have been recognized in 4 categories of the 2022 CMO Leadership Awards:
Novasep has been recognized as one of the Top Pharma Outsourcing companies in Europe in 2021:
Novasep has also been nominated by CIO Review as one of the most promising CDMOs in 2021. Discover Novasep's approach explained by Jin Seok HUR, General Manager of Novasep’s Boothwyn (PA) US site!
Our API manufacturing services
Keeping your clinical program on-track requires an experienced Project Manager coupled with expertise and specialist capabilities. Novasep offers a full range of CDMO services for APIs to pharmaceutical innovators from kilograms up to hundreds of tons.
Regardless of the development phase of your API, we offer seamless development & scale-up services to provide robust long-term manufacturing solutions.
To support your drug manufacturing and be prepared for your commercial launch, our cGMP services include:
- Process & Analytical development
- Kg-lab, pilot, and production scale
- Clinical & commercial manufacturing
- Process validation
- A wide range of flexible reactor trains from 100L to 12.5m³
- Multiple API sites
- Clean rooms class 100’000
- Regulatory support
- ICH stability studies
As you work to bring your product to market, we aim at continuously streamlining and optimizing your production processes to offer cost-efficient solutions.
A dedicated Project Manager is assigned to each project to ensure the objectives are met (quality, costs, timelines) and to support you along your API manufacturing journey.
Specific expertise for API manufacturing
Manufacturing your API with us also means leveraging advanced technologies such as:
We are also a reliable and experienced manufacturing partner for Palladium cross-coupling reactions such as Buchwald, Cyanation, Heck, Sonogashira & Suzuki, … and for many other reactions.
Our 5 API manufacturing sites
Located in France and in Germany, all of our 5 European API sites are experienced with APIs manufacturing. The power of Novasep’s network lies in its ability to manage several steps of chemistry through different sites to provide flexible capacity and increase security of supply.
- Our Chasse-Sur-Rhône site, located in France, offers best-in-class CDMO services for APIs. The site has a pharmaceutical pedigree & boasts an excellent regulatory track-record with regular inspections by both the FDA & European authorities.
- 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.
- 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.
- 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.
- 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.
All our API manufacturing sites are regularly inspected by the FDA and local authorities. Learn more about our outstanding regulatory track-record in our Pharma CDMO brochure.
Capabilities for your API manufacturing
Our production plants offer a combined reactor capacity of over 500m3 with a wide range of equipment trains.
Our facilities enable us to offer a multi-site strategy to best accommodate our customers’ needs, leveraging our core technologies. For example, Novasep is highly experienced in combining synthesis & preparative chromatography, and has access to one of the largest chromatographic purification platforms worldwide.
Discover why Novasep is a first choice CDMO partner for your API manufacturing:
Our latest investments for CDMO services
Novasep has deployed an investment strategy for many years, investing continuously to upgrade its capacities and broaden the flexibility and productivity to satisfy its clients.
- Addition of a cGMP flow chemistry capability, debottlenecking of drying and purification capacities, and addition of a cleanroom
- Investment supported by ‘France Relance’
- Announced in December 2021
- Chasse-sur-Rhône, France
- Increase flexibility and competitiveness
- Investment supported by ‘France Relance’
- Announced in June 2021
- Mourenx, France
- Support growing demand for clinical & commercial supply of ADCs & HPAPIs
- Announced in May 2021
- Le Mans, France
- Increase flexibility and capacity for low to medium volume APIs
- 2 new synthesis reactors
- Fully operational by Q4 2021
- Chasse-sur-Rhône, France
Do you have an API in early phase development? Novasep provides services along your API journey, starting from your early phase needs!
