Technical Information Magazine 201911-03 Pharmaceuticals in the Era of Modalities Diversification
The technical information magazine The TRC News provides the latest information on analytical techniques that are useful for research and development, solving production troubles, and quality control.
**Abstract** In recent years, as pharmaceutical modalities such as cell therapies and nucleic acid medicines have rapidly advanced, new methods for quality evaluation that are not present in traditional pharmaceutical quality control are required. Our CMC Analysis Research Department, building on 20 years of experience in the standard testing of small molecules and antibody drugs, has quickly introduced analytical functions required for new pharmaceutical modalities and operates under a GMP framework. This paper presents examples of analytical functions applicable to ADCs, cell therapies, and nucleic acid medicines. **Table of Contents** 1. Introduction 2. Analysis of Aggregates in Human IgG Antibodies by SEC-MALS 3. Analysis of Residual Solvents in Nucleic Acids by GC-MS 4. Cell Analysis by Flow Cytometry 5. DNA Quantification by Quantitative PCR 6. Conclusion
- Company：東レリサーチセンター
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