As a pharmaceutical innovator, manufacturing a new API may seem both complex and challenging. The development and optimization of a robust, transferable, and scalable process to support long-term manufacturing requires both specialized capacities and expertise.
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.
Recognized experts in API process development and scale-up
Axplora has been a leading player in the CDMO development and manufacturing area 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 reliable CDMO services for API development
From clinical supply to commercial manufacture, Axplora offers a full range of process development and manufacturing services for APIs.
- 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 can support you through your drug development lifecycle from clinical to commercial manufacturing.
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 product lifecycle.
Our facilities for API development
|Sites||Process development||cGMP Pilot||cGMP commercial|
|Gropello Cairoli, IT||X||X||X|
|Le Mans, FR||X||X||X|
Discover why Axplora is a first-choice CDMO partner for your API development and manufacturing: