Process Development
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API Process Development, Early Phase
When you screened out your drug pre-clinical candidates (PCC), it’s time to consider IND (Investigational New Drug) application and produce the API with quality and speed. Our early phase API process R&D cross-functional teams, a total of 3,000+ process chemists and analytical scientists, can support your small molecule drugs from preclinical through IND submission to Phase II.
Our early phase API development capabilities include rapid synthesis evaluation, phase appropriate process development and analytical method development, fast delivery of tox API materials and 1st GMP batch of API materials as well as API stability study for the IND filing, followed by GMP API material resupply for Phase 1 and Phase 2 clinical studies with the continued API process and analytical method optimizations. The speed of delivery and the quality of API are enabled through our powerful process enabling technologies, such as flow chemistry, biocatalysis, chemocatalysis, Prep-HPLC/SFC and API crystallization.
In 2023 alone, we have supported about 3,000 early phase programs from preclinical to phase II.
Speed
- 1.5 weeks/step for RSMs process development and manufacturing
- 2.5 weeks/step for APIs process development and manufacturing
Experience
- All common and hazardous reactions
- High potency API and various conjugates
- Enabling technologies, such as flow chemistry, biocatalysis
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
