Process Development
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Home | Services & Solutions | Drug Substance | Process Development
API Process Development, Early Phase
Our API process development teams, comprising over 3,400 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) ≥10 ng/m³, and all enabling technologies can be applied to HPAPI process R&D and manufacturing.
Speed
- 1.5 weeks/step for RSMs process development and manufacturing, 2.5 weeks/step for APIs process development and manufacturing
- 15-20 months for late phase process validation and commercial launch, shorter than a typical industry timeline
- 12 weeks for RSM push back, QbD study and PPQ manufacturing
Experience
- 2,503 preclinical – phase 2 molecules supported (as of Q3 2024)
- 92 NCEs PPQ completed during 2018-2023, with 100% PPQ success rate
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
- 15-20 months shorter than a typical industry timeline to process validation and commercial launch
- 12 weeks - RSM push back QbD study and PPQ manufacturing
- Established workflow to accelerate analytical validation
Experience
- 92 NCEs PPQ completed during 2018-2023
- 100% success rate
Analytical Services and Quality Control
750+ Analytical Scientists
In 2022:
- 6,000+ chromatographic methods developed
- 1,000+ non-chromatographic methods developed
920+ QC Analysts
In 2022:
- 500+ projects supported
- 11,000+ batches released
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
Related Resources
Webinar: Rapid Delivery of API Enables Accelerated IND Application – Challenges and Solutions
