Cambridge Healthtech Institute’s Kent Simmons recently spoke with Dr. Vaneet Sharma, an Analytical Scientist in the Vaccine Development & Manufacturing group of International AIDS Vaccine Initiative (IAVI), about his upcoming presentation “Phase Appropriate Analytical Characterization of Recombinant Protein Based Vaccines”, to be delivered at the Early Analytical Development for Biotherapeutics meeting being held as part of The Bioprocessing Summit in Boston.

To learn more about his presentation and the conference agenda, visit www.BioprocessingSummit.com/Preclinical-Analytical-Development

Please tell us a bit about IAVI and your path to your current role at IAVI?

The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996, IAVI works with partners in 25 countries to research, design and develop AIDS vaccine candidates.

I joined IAVI in 2014 and is part of multidisciplinary team in the Vaccine Development & Manufacturing division. I oversee CMC analytical development of the recombinant protein based HIV vaccine candidates for Phase I/II clinical trials. Before joining IAVI, I worked at Novartis Vaccines to develop analytical assays supporting development of the HIV recombinant protein based vaccines. I am trained analytical scientist, I received my PhD on the LC-MS/MS method development from Northeastern University, Boston.

Could you please tell us something more about the focus of your upcoming presentation, “Phase Appropriate Analytical Characterization of Recombinant Protein Based Vaccines”

This presentation will provide an overview of control strategies and outline the phase appropriate physiochemical characterization performed for the recombinant protein based vaccines. Analytical strategies for the assay development, assay qualification and characterizing the critical quality attributes (CQAs) relevant to phase 1/2 clinical trial will be discussed. A case study will also be presented to demonstrate the application of the phase appropriate characterization to support recombinant protein based HIV vaccines development.

What, in your opinion are some of the current challenges in the analytical characterization of recombinant protein based vaccines?

Most of the recombinant protein based vaccines antigens are complex, heavily glycosylated novel biomolecules. Thus in addition to the routine issues of the recombinant protein production, they also inherently suffer from stability issues, forms higher order aggregates, increased glycan heterogeneity. Thus, analytically challenge lies not only in understanding these critical quality attributes (CQAs), but also to characterize and analyze these CQAs throughout development and GMP manufacturing to assess product consistently. Unfortunately, many of the methods required are not routinely performed or available at CMOs. Example, N-Glycosylation analysis especially the methods to perform structural characterization and site specific determination or higher order aggregate analysis using HDX-MS are very demanding procedure and are not routinely performed at CMOs. Hence, currently challenges are of operational nature, how to link these advanced technologies to manufacturing.

And what emerging and current analytical techniques will be important in the next few years in the field of recombinant protein based vaccines?

During the last decade advanced analytical techniques, tools,methods emerged to characterize the bio-therapeutics. Many of these analytical techniques are being routinely used during the research and development of biomolecules likes recombinant protein based vaccines but quality control strategy for the batch release testing or lot release testing is still based on the traditional analytical methods.

In the next decade, the demand for advanced analytics, smart analytics, methods that can test multi-attribute will increase simply because of more complex bio-therapeutics being explored as drugs and also to reduce the time/ cost of development/manufacturing.

One of the techniques that I personally feel will be routinely used at the CMOs in the next few years for multiple attributes testing during development and manufacturing is mass spectrometry.

  • Many of the validated mass spectrometry based methods such as peptide mapping, glycan analysis will be implemented as lot release methods for identity, purity, safety etc.
  • HDX mass spectrometry will be applied routinely to monitor higher order structure and aggregation analysis.
  • Mass spectrometry based methods will be routinely used to complement the ELISA based methods to detect and quantify the host cell proteins detection & quantitation.
  • Other important techniques that will be routinely used during development/ manufacturing includes ligand binding assays (BLI, SPR), SEC-MALS, AUC, Cryo-electron microscopy (cryo-EM)] etc.

A last question for you today. What are you most looking forward to at the August meeting?

I am looking forward to hearing exciting talks on the analytical characterization of biopharmaceuticals as well as on the protein production and purification. Good discussions with folks from industry and academia. Lot of Networking.

Speaker Biography:

Vaneet_SharmaVaneet K. Sharma, Ph.D., Analytical Scientist, Vaccine Development & Manufacturing, International AIDS Vaccine Initiative (IAVI)

Vaneet Sharma is an analytical scientist in the Vaccine Development & Manufacturing division of International AIDS Vaccine Initiative (IAVI). He is responsible for the analytical methods development and physiochemical characterization of the recombinant protein based HIV vaccine candidates for Phase I/II clinical trials. Prior to this position, Dr. Sharma was a scientist, technical development at Novartis Vaccines. Dr. Sharma is also member of the USP Viral Vaccines Expert Panel (2015-2020). Vaneet received his PhD from Northeastern University, MS from University of Connecticut, and BS from G.N.D. University, Punjab, India

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