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概述

药明合联 WuXi XDC
一体化生物偶联药研发平台

 

WuXi XDC, a WuXi Biologics subsidiary, is a joint venture between WuXi Biologics and the WuXi AppTec subsidiary, WuXi STA.The joint venture greatly simplifies Antibody Drug Conjugate (ADC) and other bioconjugate drug development by providing all preclinical activities, holistic and integrated CMC development process and the entire supply chain under one company and in one centralized region. The joint venture combines the existing single-source development and manufacturing platforms for payload, linker and biologics (e.g., monoclonal or bispecific antibodies or other recombinant proteins) with the company’s leading bioconjugation development technology platforms and previously established drug substance and drug product GMP manufacturing facilities.

 

The WuXi XDC comprehensive technology platform provides for our clients an integrated one-stop value chain for the development of ADCs and other bioconjugates.

 

 

All activities within the WuXi XDC technology platform are conducted within 1-2 hours (driving) thus providing an unprecedented geographic-centric value chain.

 

We provide world-class expertise in both platform and novel conjugation technologies and can handle highly potent and toxic payloads. Extensive payload and linker libraries as well as a variety of mAb library generation and screening platforms are available for development candidate matrix preparation and evaluation.  A complete ADC analytical development toolbox can be leveraged to select the most appropriate analytical methods for specific bioconjugate characterization, and to establish lot release and stability assay panels. We offer a full range of services including both integrated mAb and bioconjugate development packages and bioconjugate standalone CMC development and manufacturing packages. 

 


药明生物于2018年成立无锡药明偶联生物技术有限公司专注于生物偶联药物的开发及生产,这是药明生物第三个生物制剂生产基地(Drug Product 3, DP3),将推动药明生物助力全球创新生物偶联药物实现从概念到商业化生产全过程:

 

  • 临床前药品和毒理学材料生产
  • Ⅰ期Ⅱ期临床药品生产
  • 临床后期项目(临床Ⅲ期,PC,PPQ和商业化生产)

 

公司包括能处理高活性、OEB 5级(Occupational Exposure Band )、氧敏感和光敏感的制剂灌装及含冻干的GMP车间、偶联GMP车间、QC实验室、GMP仓库,公用工程、冻干工艺优化及放大等功能区。为全球生物医药公司提供抗体偶联药物的冻干工艺优化、技术转移、中试放大及GMP偶联制剂生产服务;同时也可为高活性化合物、细胞毒性化合物等小分子药物提供制剂灌装和冻干的中试及GMP生产服务,满足临床I、II、III期及将来的商业化生产需求。

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