As a pharmaceutical innovator, manufacturing a 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 manufacturing.
Axplora 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
Axplora has been offering CDMO development and manufacturing services for APIs for more than 30 years.
With more than 50 process steps transferred from R&D to manufacturing each year, Axplora is recognized for its process development know-how. Our strong expertise in DoE (Design of Experiments) enables us to increase process robustness, ease manufacturing scale-up, and therefore, accelerate timelines to answer your needs.
An extensive toolbox of technologies, coupled with our strength in process chemistry, allows our teams to develop and implement innovative new-generation processes, and to extend product lifecycles.
“Axplora’s experts helped us a lot to overcome technical problems in the process over the past few years”
Our CDMO services for API development
From the manufacturing of the first grams of your small molecule drug substance to several kilos, Axplora 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.
- Process & analytical development to scale up
- Process & analytical method development
- Process characterization
- Process safety assessments
- Technical transfer
- Analytical method validation
- Cleaning method validation
- Equipment validation
- Regulatory support
- Process validation
- Preparation of validation protocols
- Control of SM quality
- Production of validation batches
- Process and quality review
- Preparation of validation report
Axplora provides services all along your API journey, from development to manufacturing and routine commercial manufacturing.
Our facilities for API development
Our global network of 10 sites, located in Europe, India, and the U.S., is strongly supported by a team of committed chemistry professionals.
|Sites||Process development||Kilolab manufacturing||Pilot manufacturing||Process validation|
|Gropello Cairoli, IT||X||X||X||X|
|Le Mans, FR||X||X||X||X|
Axplora offers purification development services from its Pompey & Chasse-sur-Rhone facilities in France, and its Wilmington site in the USA, including screening & process development using state-of-the-art chromatography technology.
Our Leverkusen site develops processes including hazardous chemistry steps.
In addition, Axplora’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 compounds with an OEL below 10 ng/m3/8hrs.
Our Axplora Gropello Cairoli site is the center of excellence in the development & manufacturing of steroids.
Our facilities are closely connected and benefit from shared resources for Project Management or R&D.
Discover why Axplora is a first-choice CDMO partner for your API development and manufacturing: