Development and cGMP manufacturing of a Phase I clinical candidate
Axplora is an expert in ADCs with over 15 years’ experience and more than 200 clinical and commercial cGMP batches produced. We have a multi-scale bioconjugation manufacturing capacity with short-term availability and a fast-track bioconjugation services with seamless transition to clinical supply.
A clinical-stage biopharmaceutical company asked Axplora’s Le Mans site to perform the cGMP manufacture of an Antibody Drug Conjugate (ADC) for the treatment of solid tumors.
Highlights:
- Process and analytical development followed by cGMP manufacture of a phase I ADC
- Scale-up from gram to hundred-gram scale
- A robust process leading to 100% compliant batches
Access gated content
Fill the form below to access this resource.
Related resources
Case study
API Manufacturing
Optimizing production of a high-volume multi-step oncology API through a multi-site strategy Axplora is an expert in API (Active Pharmaceutical Ingredient) manufacturing with over 30 years’ experience and offers services from process development to commercial manufacturing in full regulatory compliance and secure supply chain. Following the FDA approval, a global pharmaceutical company requested Axplora to […]
Case study
Case study – Chromatography
Purification of a complex API using a batch chromatography process Axplora is a pioneer and market leader in preparative chromatography with more than 30’ years track record in chromatography equipment design and commercial manufacturing. We produce 1000’s tons API and more than 3000 batches with industrial chromatography. A major pharmaceutical company tasked the Axplora Pompey […]
Case study
ADC Payload
Process development and manufacturing of an ADC payload from phase I to commercial Axplora is an expert in ADC Payload manufacturing with over 15 years’ experience and more than 200 clinical and commercial cGMP batches produced. We safely handle compounds with very low OEL, below 30ng/m³/8hrs, and we can produce from 30g to > 1kg […]
We enable our partners to fully realize their ambitions.
Driven by the curiosity, skills and dedication of over 2,000 employees on three continents, Axplora delivers sustainable, technologically advanced API solutions to improve lives worldwide.