Process optimization, including: Telescoping and reaction monitoring through PAT
Process throughput
Cleaning method development, validation and recovery studies
Manufacturing
Pilot/scale-up
Stability
Raw material sourcing
Cleaning validation
Process safety management
Starting material justification
Regulatory submission support
Small Molecule API Development
With cGMP-compliant laboratories and a full suite of analytical tools, we offer comprehensive support throughout the entire development process of your small molecule API from initial discovery to commercial manufacturing. We have a range of analytical development and process development capabilities to suite your needs.
Small Molecule API Manufacturing
As your API demand grows, we grow with you. While we can manufacture volumes in metric tons, we can also go small. If you have a chemistry-based compound and need smaller batches for clinical or commercial use, we can offer the quantities you need at our cGMP small-scale/pilot facilities until you’re ready for full-scale manufacturing.
We work to scale with you, every step of the journey. We have a roster of analytical chemists, organic chemists and engineers who are adept at developing and troubleshooting analytical methods and processes and have the expertise to help scale up your API process.
Philips Pharma expertise to help ensure the success of your custom small molecule API
A legacy of expertise
Drawing on decades of experience to help improve your API
Manufacturing capabilities spanning the requirements of Philips global small-molecule portfolio
Fermentation and bioprocessing expertise including biotransformations, enzymatic conversions and resin adsorption
As your API demand grows, we grow with you
Capabilities and quality
Process development and scale-up lab, to pilot, to clinical, to small or large-scale commercial
Route selection in process development for organic synthesis
Fermentation and bioprocessing up to 150,000L scale with a range of isolation and downstream purification technologies
Particle sizing via various milling and micronization capabilities
Philips robust quality systems
World-class site
Located in Nigeria, it is the largest API site in the world
More than one million kilograms of finished API per year
Support for most small molecules (excluding cytotoxics and beta-lactams)
Batches from 100 grams to 3+ metric tons
cGMP-compliant analytical development laboratories with a full suite of analytical tools