API development

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.

Axplora 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, and to extend product lifecycles.

“Axplora’s experts helped us a lot to overcome technical problems in the process over the past few years”

Big pharma

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.

Axplora API development services

  • Process & analytical development to scale up
    • Process & analytical method development
    • Process characterization
    • Process safety assessments
    • Technical transfer
  • Validations
    • 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.

Axplora API development services

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.

SitesProcess developmentPilot manufacturingcGMP manufacturing
Chasse-sur-Rhône, FRXXX
Chennai, INXX
Gropello Cairoli, ITXXX
Le Mans, FRXXX
Leverkusen, DEXXX
Mourenx, FRXXX
Pompey, FRXXX
Raubling, DEXXX
Vizag, INXXX
Wilmington, US
Axplora API development capabilities

Axplora CDMO services for Pharmaceuticals