Large Molecule Development and Bioanalysis
Overview of Large Molecule Services
Large molecules play a crucial role in modern pharmaceuticals, providing targeted therapies for various conditions. BioDuro-Sundia offers comprehensive large molecule drug development services. Our team works with a wide range of large molecule types, including protein molecules, peptides, antibodies, and more.
From early drug discovery to rigorous testing and drug manufacturing, BioDuro-Sundia provides integrated services for large molecule development. Our team has access to some of the most advanced technologies for the analysis of large molecule drugs, including LC-MS, Gyrolab, and Meso Scale Discovery.
Why Choose BioDuro-Sundia for Large Molecule Development?
BioDuro-Sundia’s expert team has a deep understanding of the complex nuances of molecular biology, particularly in the therapeutic development of large molecules. With decades of combined experience, our team provides a tailored approach to drug development. We collaborate with you to create custom testing and analysis programs that align with your goals.
Developing large molecules is an intensive, time-consuming process, which is why we take an integrated approach for more efficient timelines. Our services include drug substance, drug product, and DMPK services under one umbrella, creating a one-stop shop for your complex molecule requirements.
Advanced Large Molecule Analytical and Bioanalytical Capabilities
Advanced bioanalytical capabilities help you better understand the structural components and performance of your large molecules. By quantifying analytes in these molecules, we enable a better understanding of how the drug will perform in the body.
We offer a wide range of in vitro assays as well as some in vivo analysis options. This includes flexible testing options for both large and small molecules.
BioDuro-Sundia is deeply committed to regulatory compliance and quality assurance. We implement rigorous quality controls in all of our large molecule bioanalysis services to deliver precise and accurate results, helping you develop safe therapeutic products. We adhere to international standards set by the US FDA and China’s NMPA, as well as GLP standards. Our commitment to these standards ensures the reliability and safety of your final products.
Characterization of Protein Drugs (HRMS-based approaches)
Protein-based drugs are complex and require detailed analysis and classification throughout the drug development process. We use a variety of high-resolution mass spectrometry (HRMS)-based approaches to develop and manufacture these macromolecules safely. HRMS is an innovative technology that measures the exact molecular mass of a target compound. It provides a detailed look at the complexity of the structure. We employ a variety of techniques, including:
Intact Mass
Peptide Mapping
Covalent Protein Adducts
Immunoassays
Flexible assay platforms: GyroLab and ELISA
Contact Us
BioDuro-Sundia provides comprehensive support for large molecule development, from characterization to bioanalytical services. To discuss your DMPK-related needs, please email us at hello@bioduro-sundia.com or
contact a BioDuro representative.
Q&A
What are “large molecules” and how are they different from “small molecules” in drug development?
Large molecules are complex structures that generate very specific reactions in the body, including proteins, peptides, nucleic acids, and more. Small molecules are much simpler compounds. Large molecules have become popular in the development of biopharmaceuticals. Because of their complex structures, they can target specific conditions with fewer side effects than small molecules.
What is the importance of characterizing protein drugs in drug development?
Characterizing protein drugs helps ensure that the final product works as intended, without harmful side effects. This process is often done using HRMS-based technology, which provides detailed insights into the protein’s structure, stability, and interactions.
What specific techniques does BioDuro-Sundia use for the characterization of protein drugs?
BioDuro-Sundia uses a variety of protein characterization techniques, including immunoassays, peptide mapping, intact mass analysis, and analysis of covalent protein adducts. All techniques are conducted with stringent quality control and compliance standards.
How does BioDuro-Sundia ensure the quality of large molecules throughout the development process?
BioDuro-Sundia uses state-of-the-art equipment such as the GyroLab and ELISA platforms to maintain large molecule quality throughout development. Additionally, we adhere to strict compliance standards and GLP practices, with regular checks to ensure safety.
What advantages do flexible assay platforms like GyroLab and ELISA offer in the study of large molecules?
GyroLab and ELISA are both versatile, sensitive platforms that work well for a wide range of sample types and sizes. They also provide detailed, robust data for detailed analysis of each drug’s pharmacokinetics, toxicology, and immunogenicity.
Can BioDuro-Sundia support all phases of large molecule drug development?
Yes, we support all phases of large molecule drug development, from discovery to development to preclinical and clinical trials. Our integrated DMPK services ensure a seamless transition through each phase of development.
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