Asymchem Laboratories (Tianjin) Co. Ltd

About Asymchem Laboratories (Tianjin) Co. Ltd

Founded in 1999, Asymchem (PRC stock code:002821.SZ) is a global integrated Contract Development and Manufacturing Organization (CDMO) providing drug R&D and manufacturing for leading pharmaceutical and biotech companies. Our mission is to drive smarter, greener and more cost-effective manufacturing to support clinical research and commercialization.Asymchem currently operates eight manufacturing facilitiesoffering solutions ranging from early clinical stage to commercial stage, including R&D, cGMP production of advanced intermediates, APIs, formulations and clinical research services. Our scientists excel in the creation and manufacture of enzymes for use in bio-catalysis, the development of practical continuous flow technologies for commercialization, and innovative research and process development from preclinical research to commercialization for both non-GMP or GMP products.Our work has frequently won us “most valuable partner” and “strategic partner” recognition from major pharma and leading biotech companies.

  • CN
  • 2015
    On CPhI since
  • 1000 - 4999
    Employees
Contract Service
Manufacturer/Innovator
Contact info

Products from Asymchem Laboratories (Tianjin) Co. Ltd

  • APIs & Intermediates

    Product APIs & Intermediates

    We leverage our experience in everything – from R&D to process innovation to navigating the complex global regulatory arena – to help clients efficiently develop and manufacture quality products  • Small Molecules
      • Carbapenems
      • Glycans
      • Peptides
      • Oligonucleotides
      • Enzymes

  • Oligonucleotides

    Product Oligonucleotides

    Asymchem’s oligonucleotide technology platform provides clients with full services in drug substance, from process development through GMP manufacturing, and drug product, from preformulation development through fill-finish. The process chemistry, analytical, formulation, and regulations teams collaborate to provide clients with a fast, efficient, and flexible integrated solution for oligonucleotide development.

    Our oligonucleotide platform is equipped with advanced technologies including GE ÄKTA oligonucleotide solid-phase synthesizer and purification equipment from gram-scale to kg-scale. In addition, analytical equipment including Q-TOF, UPLC-MS, UPLC, GPC, and other instruments can provide support for oligonucleotide structure characterization, analytical method development and validation, final product release testing, and stability research.

  • Pre-Formulation / Formulation

    Product Pre-Formulation / Formulation

    Asymchem understands that early phase work focuses on learning as much as possible about a drug compound. Our experience across numerous chemical classes and multiple dosage forms, and our ability to develop analytical methods to assess chemical identity, purity, compatibility, and stability, makes us a natural choice for this preformulation work. Our in-depth knowledge of the compound from preformulation guides us in designing manufacturing processes that control the product’s quality attributes, ensuring the product meets its Quality Target Product Profile (QTTP).

    We offer a full spectrum of analytical techniques and tools, from XRPD to proton and carbon NMR, from mass spectrometry to hygroscopicity testing. In addition, our broad experience with many diverse classes of drug substances and multiple drug product dosage forms, has increased our expertise around chemical compatibilities, degradation pathways, stability, and the tools to investigate these areas

  • Regulatory services

    Product Regulatory services

    Asymchem Laboratories (Tianjin) Co., Ltd offers wide range of manufacturing services which includes regulatory services. They generate the complete cmc data package for regulatory filings including: API synthesis flow chart, process control, raw material acceptance criteria and API specifications , API batch analysis, etc. Contact us for more information.

Asymchem Laboratories (Tianjin) Co. Ltd Resources

  • Brochure Service Overview

    Driven by curiosity and the desire to break new ground, leading scientists and technologists are attracted to Asymchem’s culture of innovation. It’s a culture built on operational agility and flexibility, a willingness to invest and share risks, and demonstrated expertise in strategic collaboration and partnership.

    Working from this forward-leaning posture, Asymchem successfully supports products at every stage of the lifecycle from preclinical to large-scale manufacturing, with custom development services ranging from investigational new drug (IND) support to Phase III clinical trials and technology transfers for commercial supply.