从临床前研究到商业化生产的全方位解决方案

从公斤级毒理批次到吨级规模化生产

无论项目处于哪个阶段 —— 临床前毒理批次公斤级生产、临床阶段放大制造，还是吨级商业化生产 —— Z IntellecChem&Tech凭借强大的生产能力与灵活性，为您提供高效优质的解决方案。

◆ 无缝工艺衔接：实验室规模→中试放大→商业化生产全流程技术转移

◆ 敏捷响应：经验丰富的技术团队确保生产工艺快速落地

 先进生产技术体系

◆ 持续技术投入：将前沿技术应用于符合 GMP 标准的规模化生产

◆ 风险预判能力：深度解析实验室反应放大至工业化生产的潜在挑战

◆ 定制化产线：适配不同项目需求的智能生产设备与工艺路线

 全维度分析支持

我们的实验室团队由资深专家组成，具备：

✅ 国际合规经验：精通 FDA、欧盟及中国药典对药物分析的技术要求

✅ 跨国服务背景：核心成员曾在海外知名机构从事多年相关研究

✅ 全流程服务能力：从方法开发到法规申报的一站式技术支持

 服务矩阵

▸ 分析方法开发与验证

▸ 杂质谱分析与控制

▸ 稳定性研究

▸ 法规文件编制

 选择我们的理由

✓ 一站式服务：研发 - 生产 - 检测全链条覆盖

✓ 合规与效率并重：严格遵循国际标准，加速项目进程

✓ 成功案例背书：为全球药企完成数百次复杂工艺转移

立即获取专属方案

+86 150-5086-6711

contact@zintellec.com

www.zzhxchem.com

Preclinical to Commercial Production Solutions

From kg-Scale to Tonne-Scale Manufacturing

At Z IntellecChem&Tech, we deliver full-spectrum production capabilities across all development stages:

◆ Preclinical toxicological batches (kg-scale)

◆ Scaled-up clinical manufacturing

◆ Commercial production (tonne-scale)

Our flexible facilities and technical expertise ensure seamless transition from lab to pilot to commercial scale, with guaranteed quality and efficiency.

 Advanced Production Technologies

◆ GMP-Compliant Excellence: Cutting-edge technologies applied to regulatory-standard manufacturing

◆ Scale-Up Assurance: Mitigate risks through decades of experience in translating lab reactions to industrial processes

◆ Customized Solutions: Tailored equipment and workflows for diverse project requirements

 Analytical Support

Our world-class lab team combines:

✅ Expertise in FDA, EU, and Chinese Pharmacopoeia standards
✅ Multi-year experience in global CROs and regulatory submissions
✅ End-to-end support for drug characterization and quality control

 Services include:

▸ Method development & validation
▸ Impurity profiling
▸ Stability testing
▸ Regulatory documentation

 Why Partner with Us?

✓ One-Stop Capability: Integrated R&D, production, and analytics under one roof

✓ Speed & Compliance: Accelerate timelines while maintaining global regulatory standards

✓ Proven Track Record: Trusted by top pharma companies for complex process transfers

 Get Started Today

 +86 150-5086-6711

contact@zintellec.com

www.zzhxchem.com