I had the pleasure of participating in the 5th International Symposium on Higher Order Structure of Protein Therapeutics, also known as HOS2016, sponsored by CASSS. The meeting was at the Renaissance Hotel in Long Beach, California April 11-13, 2016. I was joined by my Malvern colleagues Rajib Ahmed and David Sanborn.
The HOS Symposium is a platform for open discussion of development and optimization of analytical techniques to study HOS of proteins and biopharmaceutical products (including monoclonal antibodies and antibody-drug conjugates), biocomparability, and biosimilars.
Protein higher order structure (HOS) includes the secondary, tertiary and quaternary structures of a protein, which comprise the three dimensional structures that are necessary for structure and function. Changes in the HOS of proteins can contribute to the quality attributes, and potentially safety, efficacy, and pharmacokinetic properties of protein therapeutics. Regulatory agencies require assessment of HOS to investigate how protein structure is affected by manufacturing, storage and delivery; and analytical biosimilarity is an important part of evaluating potential changes in clinical safety and efficacy.
There are many biophysical characterization methods and tools used in monitoring the attributes of protein therapeutics such as conformation and higher order structure.
Use of the appropriate biophysical methods, along with method development and qualification, to characterize the quality attributes at different stages of the product lifecycle is therefore a matter of interest to biopharma and regulatory agencies.
This 2 ½ day symposium attracted over 100 attendees from biopharma, universities, government labs from the US, Canada, Germany, UK, Denmark and Switzerland.
Presentations included discussion of these biophysical assays used in HOS analysis:
- Analytical ultracentrifugation-based methods
- Viscosity/zeta potential measurements
- Mass spectrometry (MS)- based methods
- Fourier transform infrared spectroscopy (FTIR)
- Differential Scanning Calorimetry (DSC)
- Differential Light Scattering (DLS) and Static Light Scattering (SLS)
- X-ray crystallography-based methods
- Raman spectroscopy-based methods
- Nuclear magnetic resonance (NMR)
- Circular dichroism (CD)- based methods
- Computer modeling/molecular dynamics
- Electron microscopy-based methods
Each scientific session was followed by a Q&A/panel discussion with the speakers. One session was an opportunity for young scientists to present their research. There was also a lively roundtable discussion with representatives from the US FDA, European EMA and Health Canada discussing regulatory concerns for new biologics and biosimilars.
There were about 20 posters on display. The poster and exhibit hall was well-attended during the symposium, and there were several opportunities for attendees to network.
One poster that generated interest was presented by Amber Fradkin, Kevin Dahl and Matt Baker of KBI Pharmaceuticals, Colorado, and John Carpenter and Aaron Krueger of University of Colorado. Their poster focused on the use of complementary particle and biophysical techniques to evaluate biosimilarity of commercially available biopharmaceutical formulations in syringe and vial configurations. Using a combination of techniques, including Malvern Instruments’ Nanosight, Viscosizer, Morphologi G3-ID, Helix, and MicroCal VP-Capillary DSC, they demonstrated that each method provided valuable information about the samples, highlighting the value of multiple assay types to assess therapeutic protein product profiles for comparability.
For more information about CASSS and the HOS symposium, click here.
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