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

经验

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.

赋能技术平台

flow chem image

流动化学

biocatalysis

生物催化

Preparative HPLC and SFC

制备级HPLC, SFC和SMB

Crystallization & Particle Engineering

结晶与颗粒工程

相关资源

滚动至顶部
请在浏览器中启用JavaScript来完成此表单。
Checkboxes