Contract Quality Organization (CQO) Services

 

1. CQO (Contract Quality Organization) services:

JADE provides state-of-the-art international Quality management concepts and builds them into Quality systems for biological therapeutics development companies.  JADE offers bilingual services such as strategy, system building, training, regulatory filing, leading execution, and continuous improvement.  JADE’s comprehensive Quality management services are usually long term endeavors and solve the common problem of lacking sufficient expertise in all aspects of Quality management for most of the emerging biologics therapeutics companies in China and in the world.


State-of-the-Art Bespoke Quality Systems for biologic therapeutics

  • Designed to ensure compliance with multi-national Health Authority (HA) and Harmonized Global Requirements
  • Scalable – Systems designed to meet current and future needs, ensuring phase appropriate compliance to enable vs. hinder progress
  • System life-cycle – incorporating continuous improvement and risk management systems that adapt and evolve to meet Health Authority, Market, and Internal demands

Comprehensive Quality Management

  • Provides comprehensive quality services from ‘A to Z’  using its team of experienced Quality professionals to provide experience-based support to enable the clinical development of lead therapeutic candidates
  • Registration (Filing)
  • Strategy
  • Systems
  • Training

Long-Term

  • Based on partnership with our clients, JADE Biomedical integrates into your firm as an integral part of the management team designing Quality operations to ensure global compliance and long-term product efficacy, purity, safety, and quality
  • Bilingual - Fluent, Native Speakers of English and Mandarin
  • Original text with official versions in English or Simplified Chinese


2. GMP Testing Services specialized for the  bio-pharmaceutical industry:


JADE Quality Control (QC) testing centers have been in operation in compliance with global cGMP. Our Phase I Lab is in Shanghai Pudong and the Testing Services there cover all common and customized QC methods used in the fastest growing therapeutics in China such as monoclonal antibody, CAR-T, etc. 


Good Manufacturing Practices (GMP) Testing Services — specialized for bio-pharmaceutical therapeutics:

  • And more...

Examples of JADE Biomedical Services

Establish Quality Systems, GMP System Audit, Gap Analysis & Remediation

Facility Design GMP Review, Utility, Equipment Validation

Product Specification, Control Strategy Guidance

IND Filing for US, EMA and NMPA

QC Method Validation,and GMP Testing Services

GMP Training on General and Specific Topics

具体服务内容

质量技术承包服务(CQO)

定制承包及执行国际化高端生物药从研发到产业化及上市后全程的质量体系,包括但不限于以下:


  • 厂房设施设计评审,厂房设施设备/实验室验证方案及执行指导,设备管理及运维指导、验证执行指导。
  • 环境监测规划、EMPQ、设备IOPQ方案及报告起草审核,指导执行。
  • 清洁消毒剂研究
  • CQA, CPP和QBD控制策略指导。
  • 物料和供应商的质量管理流程和审计,物料质量标准。
  • 质量体系设计、搭建、运行指导及持续改进等。
  • 生产监督、偏差管理、变更控制、产品放行、冷链验证。
  • QC方法验证策略、技术转移方案。
  • 工艺及QC方法变更可比性研究。
  • GMP稳定性方案设计、有效期限制定。
  • 溶出物与析出物研究方案报告。
  • 各类质量风险评估。
  • 上市前DOE最终控制策略,物料/供应商资质评估。
  • IND/NDA/BLA中美欧申报,撰写,监管机构会议,GMP PAI检查支持,缺陷项评估整改。

GMP检测服务

生物制药、细胞基因治疗等生产放行相关样品检测、分析方法开发、验证、方法转移指导及OOS调查指导服务,涉及微生物、生物活性、生化分析、理化分析等分析方法。涵盖工艺开发、IND申报、Ⅰ/Ⅱ/Ⅲ期临床、NDA申报、商业化上市及之后所有阶段。


  • 生物制药样品检测:

 支原体检测、细胞活性检测、流式细胞相关检测分析、微生物限度检测、培养基功能性测试、残留DNA CHP、Protein A检测、内毒素检测、蛋白含量检测、及其他药典方法检测等。 


  • 产品工艺特殊化方法开发与验证

 支原体qPCR法、快速无菌检测法、细胞活性检测法、细菌内毒素定量分析法、binding ELISA等。  


  • 药典替代方法验证:

支原体替代方法验证、快速微生物替代方法验证等。


  • 其他验证服务:

消毒剂验证、清洁验证等


  • 方法转移指导

指导分析方法转移方案、执行及接受标准,以确保分析方法能有效重现。


  • OOS调查指导

对各类型实验室OOS调查进行指导包括调查性检测。


  • 各类生物制药用水检测:

纯化水,超纯水,注册用水药典方法检测