Home | Services & Solutions | Drug Substance | Process Development

API Process Development, Early Phase

Our API process development teams, comprising over 4,000 process chemists and analytical scientists, support your synthetic drugs from preclinical to clinical and commercial launch. We support a wide spectrum of small molecules, including starting materials and intermediates, and API. We can also handle high potency API with OEL 10 ng/m3.

Our API process R&D platform is equipped with broad enabling technologies including crystallization and particle engineering, flow chemistry, biocatalysis, chem-catalysis, prep-HPLC, SFC (Supercritical Fluid Chromatography) and SMB (Simulated Moving Bed Chromatography).  These technologies can support molecules from preclinical to commercial at any scale. 

Our high-potency API platform can handle molecules with an Occupational Exposure Limit (OEL) of 10 ng/m³, and all enabling technologies can be applied to HPAPI process R&D and manufacturing.

Speed

Experience

API Process Development, Late Phase

When you approach the end of Phase II clinical trial, you need to consider a robust supply for larger late-stage clinical trials and eventual commercial life cycle management. Our late phase API process development teams of 700+ process chemists and analytical scientists can support your drugs from Phase II through marketing application submission and commercial launch.  We support a wide spectrum of synthetic molecules, including regulatory starting materials, API intermediates, APIs and high potency products.

We are highly experienced in RSM strategies helping you to reduce the risk and accelerate NDA submission.  We perform assessment of your proposed RSM designation and determine whether it is compliant with the FDA/EMA/NMPA ICH guidelines. Based on sources and levels of risk, we will deploy custom-tailored development strategies to de-risk and streamline your NDA/MAA submission. 

Our GMP manufacturing equipment enables production of batches as large as metric tons and have proven records of inspections from the US FDA, EMA, China NMPA, and other health authorities.

Speed

Experience

Analytical Services and Quality Control

750+ Analytical Scientists

In 2022:

920+ QC Analysts

In 2022:

Regulatory Starting Material (RSM) Service

Concerned about regulatory starting material designation and potential push-back by health authority? Our RSM service helps you to reduce the risk and accelerate NDA submission.

Our process and analytical teams will perform assessment of your proposed RSM designation and determine whether it is compliant with the FDA/EMA/NMPA ICH guidelines. Based on sources and levels of risk, we will deploy custom-tailored development strategies to de-risk and streamline your NDA/MAA submission.

Enabling Technology Platform

flow chem image

Flow Chemistry

biocatalysis

Biocatalysis

Preparative HPLC and SFC

Preparative HPLC & SFC

Crystallization & Particle Engineering

Crystallization & Particle Engineering

Related Resources

Scroll to Top
Please enable JavaScript in your browser to complete this form.
Checkboxes