工艺开发
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API Process Development, Early Phase
我们的原料药工艺开发团队由4,000多名工艺化学和分析科学家组成，支持化学合成药物分子从临床前，到临床，到商业化的工艺开发和生产。我们支持各类小分子的起始物料，中间体，和最终原料药的工艺开发， 赋能范围涵盖传统小分子，PROTAC， GalNAc，Lipid， 多肽（液相合成法），寡核苷酸（液相合成法），高活小分子，高活载荷（payload）以及高活载荷-连接子（payload-linker）等化合物。
我们为原料药工艺开发团队配备了全面的赋能技术平台，包括结晶和颗粒工程、流动化学、酶催化、金属催化、制备HPLC、SFC（超临界流体色谱）和SMB（模拟移动床色谱）等业界领先的技术支持。这些技术可以支持任何规模的，从临床前，到临床，到商业化的工艺开发和生产。
我们的高活原料药平台可以支持职业接触限制（OEL）≥10 ng/m³ 的化合物工艺开发和生产，并且可以使用赋能技术平台的所有新技术。
速度
- RSM工艺开发和生产可达每步1.5周，原料药工艺开发和生产可达每步2.5周
- 后期工艺验证和上市仅需15-20个月，比业界常规时间更短
- RSM退回，QbD研究和PPQ生产总共仅需12周
经验
- 支持了2,498个临床前到2期临床的分子（截至到2024年第一季度）
- 在2018-2023期间，完成了92个新化学分子的PPQ，且100%成功
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.
