Biological Macromolecules: Exploring Analytical Development and QC Case Studies in Antibody Developability and Biologics CMC

Life Sciences, Pharmaceutical, Drug Discovery & Development, Laboratory Technology, Fundamental Research,
  • Wednesday, October 19, 2022

Biological macromolecules (monoclonal antibodies, recombinant proteins, fusion proteins, antibody-drug-conjugates, polypeptides and vaccines, etc.) are powerful therapeutics, and their characterization has drawn considerable attention and urgency in the biopharmaceutical industry. A developability assessment at an early stage can provide a better understanding of candidates, deliver better and safer therapeutic candidates and reduce risk during late-stage development.

In this webinar, the featured speakers will review:

  • Antibody quality attributes that are critical to development and traditional and state-of-the-art analytical methods to monitor those attributes
  • A practical workflow for developability assessment, including in silico evaluation, extended characterization and preliminary stability studies using appropriate analytical methods
  • Case studies on conducting developability assessment experiments

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Unlike small-molecule drugs (150–600 Da) that have rigid structures, macromolecules undergo complicated folding and can exist in several low-energy structures, posing a challenge for traditional methods in structural biology. The complete analysis and appropriate characterization of macromolecules are important to their safety, purity, potency, stability and overall quality. This webinar reviews the methodologies that are used to characterize important attributes of biopharmaceutical proteins.

Biophysical characterization is critical to understanding details of the structure-function relationship of biological macromolecules. Microcalorimetry techniques are powerful tools for in-depth characterization of molecular binding events and structural stability. These techniques generate comprehensive thermodynamic profiles for protein domain structures and the energetics of inter- and intra-molecular binding events. In addition, they help determine stability and affinity. Mass spectrometry has widely been used as a tool for identification of proteins because it can provide accurate information on molecular masses of biological molecules with a small amount of sample in a short time. Also, it can give information on the tertiary structure or on the molecular interactions of biological macromolecules.

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The speakers will discuss relevant analytical methods, including techniques (SPR, BLI, DSC, DLS, CD, LC-MS/MS, etc.) to determine thermal stability, activity, protein sequence, post-translational modifications, degradation, glycosylation, folding, disulfide bond shuffling and aggregation. An aberrant result for these attributes may raise quality issues.

Register for this webinar to get technical insight into analytical technologies in biophysical and mass spectrometry characterization as well as affinity analysis for biological macromolecules.

Speakers

http://Jinghan%20Su,%20ChemPartner%20Biologics

Jinghan Su, Assistant Director, Head of Developability, ChemPartner Biologics

Dr. Jinghan Su researched targeting drug delivery systems based on nanotechnology in Shanghai Institute of Materia Medica until 2017. She has published 10 SCI papers on Adv Mater, Adv Funct Mater, Theranostics, Biomaterials, etc., with an IMPACT factor of 104 in total and cited more than 280 times. In 2017, she joined Chempartner Biologics where she leads the research and development of biologics products and has successfully led or supported over 30 biologics formulation and process development projects.

Message Presenter
http://Qian%20Sun,%20ChemPartner%20Biologics

Qian Sun, PhD, Director, Head of Analytical Development and Quality Control, ChemPartner Biologics

Dr. Qian Sun worked in biomedicine and clinical biotechnology for many years in the United States. He has technical expertise in preparation, purification and characterization of biological macromolecules, with a focus on analytical development and quality control and execution of analytical methods for pharmaceutical raw materials, drug substance, drug products of biopharmaceuticals including antibodies, recombinant proteins, fusion proteins, antibody-drug-conjugates, polypeptides and vaccines, as well as viral-and cell-based therapies. He is a member of the European Cancer Prevention Organization, and he serves as a reviewer or editor of several international medical science journals.

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Who Should Attend?

Senior Scientists interested in biologics drug development and manufacturing

What You Will Learn

  • Introduction, workflow and C26 case studies for antibody developability assessment
  • Review the importance of analytical technologies for biophysical and mass spectrometry characterization and affinity analysis in biological macromolecules
  • Discuss analytical characterization and quality control in biological macromolecules

Xtalks Partner

ChemPartner

Over the past twenty years, ChemPartner has evolved from the pure chemistry service provider to a research innovation engine with a broad portfolio of services spanning from discovery through development and manufacturing in both small and large molecule therapeutics.

Shanghai ChemPartner, which includes ChemPartner and ChemPartner Biologics, offers a broad range of drug discovery, development, and manufacturing services including discovery chemistry and biologics, biology, pharmacology, DMPK, and exploratory toxicology as well as small molecule and biologics CMC development and manufacturing.

As more and more pharmaceutical and biotech companies look for alliance partners to provide intellectual contributions and exceptional technical expertise, ChemPartner is uniquely positioned to not only be a service provider, but to be a true biopharmaceutical alliance partner.

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