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Pharmaceutical Research CDMO Service Platform

Pharmaceutical Research CDMO Service Platform

Deeply integrate R&D experience, constantly climb the peak of R&D technology, and build an integrated innovation service platform for new drug R&D.

Pharmaceutical Research CDMO Service Platform

The Medicilon Process Department is deeply involved in the entire industrial chain of R&D, procurement and production, from preclinical small-scale synthesis route optimization, process development and scale-up, process validation, quality research to commercial production.
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One-stop API Technology R&D Platform
Preparation CDMO Service Platform

Service Cases

美迪西助力全球首款中重度哮喘治疗吸入式纳米抗体药物LQ036获批临床.webp

World's First Inhaled Nanobody Drug LQ036

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助力国产抗流感新药ADC189制剂研发,美迪西与安谛康达成合作.webp

Assisting the development of the Chinese new anti-influenza drug ADC189 preparation, Medicilon and AnDiCon Bio reached a collaboration

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美迪西助力浙江柏拉阿图PA1010片获临床试验默示许可.webp

Medicilon assisted Zhejiang Bolaatu Medical Technology Co., Ltd on PA1010 tablets with implied permission for clinical trials

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FAQs
  • What are the Main Factors that Affect the Speed of R&D?

    Long lead time for salt structure screening and crystal structure screening

    Analysis method development and optimization is not deep enough, repeated development and optimization

    The ability to find a better API purification method in a short time during process optimization

    Lag in impurity study, methodological validation cannot be carried out quickly

    The impurity coverage of the safety assessment batch is not comprehensive

  • What is the Goal of Process Development?

    The purpose of API manufacturing process development is to establish a commercial manufacturing process that can consistently produce the API of expected quality.

  • Characteristics of an Excellent API Synthesis Process

    Feasibility

      Whether the process route adopted can produce the target compound

      Whether the reaction conditions can meet the requirements of the industrial process route for raw materials, equipment, and reaction conditions in the commercial production

      The problem of three wastes can be solved

    Controllability

      Good reproducibility

      Consistency of product quality from batch to batch and meeting the expected quality standards

    Rationality

      Raw materials: readily available

      Selection of solvents and reagents: Preferably low toxicity, under ICH guidelines

      EHS: Environmental protection and labor protection comply with laws and regulations

      Cost: Competitive

      

Relevant laboratories
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  • DSC+TGA
  • Liquid and mass Analysis Laboratory
  • Pharmaceutical Research Lab
  • Infrared XRPD
  • Pharmaceutical Research ICP-MS
  • Pharmaceutical Research TOC equipment
  • Pharmaceutical Research analytical equipment
  • Pharmaceutical Research-LCMS
  • Pharmaceutical Safety Research