John F. Carpenter 

Professor Emeritus of Pharmaceutical Sciences  - University of Colorado, School of Pharmacy 

John F. Carpenter, Ph.D. is Professor Emeritus of Pharmaceutical Sciences at the University of Colorado School of Pharmacy, and a Co-Founder and former Co-Director of the University of Colorado Center for Pharmaceutical Biotechnology. His research interests include mechanisms for protein degradation and stabilization in pharmaceutical formulations, during bioprocessing and in drug delivery systems. Also, he has worked for several years to define rational strategies for stabilizing proteins and vaccines during freeze-drying and storage in the dried solid. He has published more than 300 peer-reviewed papers and is an inventor of more than 30 issued patents. He is an Editor for Reviews and Commentaries for the Journal of Pharmaceutical Sciences. He serves on the Editorial Advisory Boards for Pharmaceutical Research, The AAPS Journal, Journal of Pharmaceutical Sciences, Current Pharmaceutical Biotechnology, Molecular Pharmaceutics and BioPharm International. He has received several teaching awards and The Ebert Prize. He is a Fellow of the American Association for Advancement of Science, the American Association of Pharmaceutical Scientists (AAPS) and the National Academy of Inventors, and has received the AAPS Research Achievement Award in Biotechnology. He also was a co-founder and an organizer for the Colorado Protein Stability Conferences.

Talk: Mechanisms of aggregation and stabilization

Abstract: 

Rina Dukor 

President & Co-Founder - BioTools, Inc

Rina Dukor is the President & CEO of BioTools, a company she co-founded with Professor Laurence Nafie in 2000. Upon receiving Ph.D. in physical chemistry from the University of Illinois, Chicago (UIC) in 1991, she worked for Amoco (AbbVie) where she pioneered and later commercialized technology for structure elucidation of protein biologics through development of instrumentation, sampling techniques and software. At BioTools she led commercialization of two new revolutionary techniques known as VCD and ROA. Under Dr. Dukor’s leadership, BioTools has cemented a world-wide reputation as a leader in structure characterization of biological and chiral drugs and developer of unique advanced technologies. BioTools has won several Awards, including the R&D 100 Award, known as “Oscars of Technology’. Rina has co-authored over 60 peer-reviewed papers; several review chapters and is a holder of four patents. She is a recipient of several prestigious scientific Awards and serves on several non-profit, academic, and commercial Boards including the Board of Visitors for LAS College at UIC and Scripps Florida.

Talk: Breakthrough CD & FTIR Analysis for mAbs, ADCs and AAV’s

Abstract: The most common spectroscopic techniques used for biophysical characterization are CD and FTIR.  Unfortunately, the standard method of CD analysis requires knowledge of the exact concentration and/or extinction coefficient.  And the results are dependent on the program and dataset used.  Quite often the results do not match those from FTIR because of the methodology (actual math) but mostly the datasets are quite different.

We are excited to introduce a disruptive new method for CD  - one that does not require any prior knowledge – no more measuring exact concentrations!  It is fast, and easy and is implemented in industry-standard ProtaCal software.  And the CD and FT-IR results agree with each other!  

Note: the new CD software is available exclusively through BioTools and Applied Photophysics. We will also discuss a new algorithm for the characterization of AAV samples using both FTIR & CD. And as time permits, we will compare the HOS techniques for all new modalities that also include GLP-like peptides and oligonucleotides.

Karl Maluf 

Director of Analytical Services - KBI Biopharma 

N. Karl Maluf Ph. D. is the Director of the Biophysical Characteriztion Core at KBI Biopharma which focuses on the characterization of higher order structure and stability of biological macromolecules.  Dr. Maluf is well know as an expert in Analytical Ultracentrifugation analysis, having more than 25 years of experience in the field and numerous publications utilizing the technique.

Talk: How to Identify and Quantify Adeno-Associated Virus Fill States Using Analytical Ultracentrifugation

Abstract: Recombinant adeno-associated viruses (AAV) are used extensively as a vector for gene therapy. AAV products are composed of a proteinaceous capsid that encapsulates the single stranded DNA genome.  Preparations of purified AAVs typically contain capsid species ranging from empty capsids, various partially-packaged capsids that contain less than the full complement of intended DNA, fully-packaged capsids which represent the drug product, and, in some cases, over-packaged capsids that contain more than the full complement of intended DNA. Characterization and quantification of these species is necessary to ensure safety and efficacy of gene therapy treatments.

Recently, Maruno et al.  published a comprehensive analysis using sedimentation velocity analytical ultracentrifugation (SV-AUC) to characterize AAV size distributions using multiple detection wavelengths. Not only does it allow for physical separation of the species through ultracentrifugation, the method also enables identification and quantification of well resolved species. In this talk, we discuss how to implement this analysis to identify various fill states in an AAV preparation.

Tonya Zeczycki

Associate Professor & Director, BSOM’s Mass Spectrometry Core Facilities - East Carolina University

Tonya Zeczycki is an Associate Professor in the Department of Biochemistry and Molecular Biology and Director of the Mass Spectrometry Core Facilities at the Brody School of Medicine at East Carolina University. Applying biophysical, enzymology, and mass spectrometry techniques, her lab focuses on understanding why physiological proteins “go rogue” in neurodegenerative diseases. By examining the structural, mechanistic, and biophysical underpinnings of basic neurodegenerative disease biology, her lab hopes to resolve the long-standing question of how pathological proteins in Parkinson’s, Alzheimer’s, and Alzheimer Disease Related Dementias transform from proteins performing important physiological tasks to ones associated with disease pathologies. 

Talk: Controlling the chaos: Allosteric redox regulation and TG2-mediated disease pathologies.

Abstract: While the importance of Transglutaminase 2 (TG2) to numerous fundamental biological and pathological processes is undisputed, the structure-function relationships describing the regulation of TG2’s transamidase activities underpinning its pathological role in neurodegenerative disease are dubious. This is due in part to TG2’s atypical behavior; TG2 is the rebel of the transglutaminase family. Not only is it the only one with both allosterically regulated transamidase and GTPase activities, but it is also extremely extremely promiscuous and interacts almost exclusively with protein substrates that contain high amounts of intrinsic disorder. To resolve the long-standing questions regarding TG2’s pathological functions, we present here biophysical and biochemical data supporting the role dynamic, redox-sensitive structural features in TG2 have on governing its multiple activities and interactions with intrinsically disordered protein partners. 

Jesse Coe

Associate Director, Business Development - KBI Biopharma 

Jesse Coe earned his bachelors in mathematics and chemistry in 2011 before earning his Ph.D. in chemistry in 2018, focused on structural biology of membrane proteins and protein structural dynamics. After a postdoc at Stanford, Jesse transitioned into industry, moving to KBI in 2020. He spent 4 years in the analytical formulation sciences department in roles spanning from his start as a scientist focused on preformulation development and culminating in leading a team supporting clients from preclinical through late phase. He recently transitioned into KBI’s business development department as an associate director. He particularly enjoys building client relationships and approaching complex challenges and processes. Outside of work, Jesse spends most of his time with his partner Clarie, 6-month old daughter Lydia, and two corgi’s Remy and Rosie. Beyond this, he enjoys snowboarding, playing baseball, reading and travelling.

Talk: Characterization and Control Strategy for an ADC

Abstract: This presentation delves into the critical aspects of late-stage characterization for antibody-drug conjugates (ADCs) and their role in a robust analytical control strategy essential for successful marketing applications. Starting with an explanation of product characterization and its necessity, we outline its integration into the control strategy, highlighting its role from preclinical development through commercial production