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About Company

Shenzhen Mingjian Testing Professional Technology Co., Ltd Headquartered in the North Zone of Nanshan High-Tech Park, Shenzhen, Mingjian is South China’s first CMA and CNAS dual-accredited one-stop quality service platform for biopharmaceutical products. Recognized as a National High-Tech Enterprise, National Science & Technology SME(Small and Medium Enterprises), and Innovative SME. Mingjian adheres to the quality policy of “Scientific, Impartial, Professional, Efficient”, focusing on the quality assurance of the global biopharmaceutical value chain. We provide integrated solutions for the R&D and production of diverse biopharmaceuticals, including cell and gene therapies, antibody drugs, and vaccines, committed to “Growing Together, Winning the Future” through innovative models and services.

  • 10000 +
    Annual Inspection Batches
  • 300 +
    Clients Served
  • 300 +
    Method Development & Compliance Validations
  • 30 +
    Successful IND Filing Experiences

Testing platform

质粒检测
慢病毒
菌种检测
细胞检测
外泌体检测
  • 质粒检测

    质粒(英语:Plasmid),是指在细胞的染色体或核区DNA之外,能够自主复制的DNA分子(字源:plasm为生殖质,-id表示粒)。质粒与染色体最主要的区分是,质粒不是细胞生存所必需,染色体则是细胞生存必需的。
  • 慢病毒

    慢病毒属(学名:Lentivirus)是逆转录病毒科下的一个属,此属病毒的特征是有较长的时间的潜伏期,例如人类免疫缺陷病毒(HIV)、猴免疫缺陷病毒(SIV)、马传染性贫血(EIA)、 猫免疫缺陷病毒(FIV)都是慢病毒属,学名中“Lenti-”在拉丁文中有慢的意思。其共同特点为在其基因组的3'和5'有高度保守的LTR序列,其R区域用以整合酶的识别。
  • 菌种检测

  • 细胞检测

    我们的检测平台设有生物安全二级实验室,致力于提供高标准、高质量的生物质检服务。实验室严格遵循国家认证认可监督管理委员会(CMA)、中国合格评定国家认可委员会(CNAS)和良好生产规范(GMP)等质量体系,确保检测结果的准确性和可靠性。
  • 外泌体检测

    外泌体是指包含了复杂 RNA 和蛋白质的小膜泡 (30-150nm),现今,其特指直径在40-100nm的盘状囊泡。1983年,外泌体首次于绵羊网织红细胞中被发现, 1987年Johnstone将其命名为“exosome”。多种细胞在正常及病理状态下均可分泌外泌体。其主要来源于细胞内溶酶体微粒内陷形成的多囊泡体,经多囊泡体外膜与细胞膜融合后释放到胞外基质中 。

Quality CRO

AABB certification services
AABB (American Association of Blood Banks) certification is a globally recognized benchmark in cell therapy, transfusion medicine, and related fields. It signifies adherence to the highest standards of quality, safety, efficacy, and ethics, empowering institutions to strengthen competitiveness and market trust.
IIT registration services
We provide end-to-end clinical project services, covering application submission, ethics review, human genetic resource (HGR) filing, and project execution. Our one-stop solutions, supported by efficient project management and competitive pricing, ensure timely and seamless delivery.
IND registration consulting services
We offer full-cycle IND project management services, combining robust oversight and cost-effective solutions to expedite regulatory approvals.
Analytical method development and validation
Our platform offers tailored analytical method development and validation services. Aligned with regulatory requirements from NMPA, FDA, EMA, and ICH, we design protocols based on the Chinese Pharmacopoeia and ICH guidelines, ensuring scientific rigor and compliance throughout the development process.
Human Genetic Resources (HGR) Management Consulting
- On-site audits/organizational structure and workflow optimization/on-compliance identification
- Coaching plans, Regulatory training and compliance planning
- Ethical review guidance,documentation preparation,and system implementation
- Pre-submission review and personnel capacity building
- Defense material preparation and technical review rehearsals
- Comprehensive staff competency enhancement
CNAS Accreditation Consulting
The China National Accreditation Service for Conformity Assessment (CNAS) evaluates conformity assessment bodies (e.g., certification, testing, and inspection agencies) against international/national standards. Accreditation confirms their technical and managerial competence, followed by issuance of an official CNAS Certificate.
CMA Certification Consulting
Provincial Market Supervision and Administration Bureaus conduct comprehensive evaluations of testing institutions under the Inspection and Testing Institution Qualification Accreditation Guidelines. CMA certification is a mandatory requirement for third-party testing agencies, ensuring impartiality, authority, and market credibility.