Professor Steven Cramer is an Institute Professor at Rensselaer Polytechnic Institute, Troy, New York. The Cramer lab’s research over the past 37 years has helped to improve the state of the art of downstream bioprocessing and its successful implementation for the biomanufacturing of biological products. Current research in the Cramer lab using a combination of biophysics, molecular dynamics simulations and chromatography with ligand protein libraries has provided insights into the design of novel multimodal chromatographic systems. Recent work on integrated biomanufacturing and expedited process development is having an impact on how bioprocess development is carried out in the industry. The Cramer lab is now actively involved in gene therapy downstream biomanufacturing projects, continuous mRNA processing, and several big data modeling efforts. Professor Cramer has won numerous awards including the ACS National Award in Separations Science and Technology, the ACS BIOT Division’s Michaels Award in the Recovery of Biological Products, the Gaden award from the ACS BIOT Division, and several awards from RPI including the Wiley Distinguished Faculty Award and the School of Engineering Outstanding Professor and Research Excellence Awards. Cramer has been elected a member of the National Academy of Engineering and U.T. Austin’s Academy of Distinguished Chemical Engineers. He is also an elected fellow of the American Association for the Advancement of Science, American Institute of Chemical Engineers, the American Chemical Society, and the American Institute for Medical and Biological Engineering. He has published extensively in the field with 230 publications, and the 57 Ph.D. graduates from the Cramer lab have had a significant impact with many of his former students now playing key leadership roles in the state of the art of industrial bioprocessing at most of the major biopharmaceutical and bioseparations companies worldwide as well as academia.

Tatjana is a scientist in the field of mechanistic modeling, researching and developing the GoSilico™ Chromatography Modeling Software at Cytiva. She has extensive background with in vitro and in silico chromatography process development, flow-through operations and scaling. She has studied for a Bachelor and Master of Sciences in Chemical Engineering, and a Dr.-Ing. in biopharmaceutical process development. Tatjana enjoys bringing novel in silico tools to the industry, and searching for an improved understanding of the mechanistic behavior of bioprocessing, enabling rapid process development.

Marko Tesanovic's academic journey began with a bachelor's degree in Mechanical Engineering from RWTH Aachen University. His academic pursuits further led him to acquire two master's degrees: an M.Sc. in Process Engineering from the RWTH Aachen, and an M.Sc. in Management Science & Engineering from Tsinghua University, Beijing. Currently, as a doctoral candidate at the Technical University of Munich, he is engaged with the Chair of Bioseparation Engineering. His research centers on advancing high-gradient magnetic separation technologies within the field of biotechnology, with a particular focus on developing mathematical models and a digital infrastructure for magnetic separators. This work is aimed at enabling in silico methods that could facilitate future digital twin technologies. In addition to his research, he is involved in a start-up specializing in software for downstream processing, which has received funding from the German government in 2023

Chyi-Shin Chen is a scientist with experience in bioprocesses and data science. She is currently employed at Chugai Pharmaceutical, focusing on downstream process technology development. Prior to this, she served as a Senior Process Engineer at Berkeley National Laboratory, specializing in bioprocess engineering. Chen earned her PhD in chromatography modeling from Yamaguchi University. In her present role at Chugai Pharmaceutical, she is working on the development of downstream process technologies, including in silico models and digital infrastructure design, to expedite process development.

Hi! My name is Scott H. Altern. I recently graduated from Rensselaer Polytechnic Institute with my Ph.D. from Prof. Steven Cramer’s group. The focus of my thesis was on mechanistic modeling of multimodal chromatography. Since graduation, I joined the Purification Development team at AbbVie as a Senior Scientist. My work at AbbVie has been centered on high-throughput experimentation and mechanistic modeling to accelerate process development workflows. I am very thankful for the opportunity to be here at PREP!

Soumitra is a 5th year graduate student at the University of Delaware Chemical and Biomolecular Engineering department, working under Dr. Abraham Lenhoff. His skills include chromatography, column modelling and biophysical characterization of proteins.

Dr. David Roush is currently CEO/Distinguished Scientist at Roush BioPharma Panacea, LLC (RBP). RBP is an enterprise dedicated to the successful development and optimization of biological products via strategic guidance derived from and leveraging a combination of strong scientific and engineering fundamentals and a plethora of experience. The organization provides scientific and technical guidance/consulting on all aspects of process development (ex. Developability, Control Strategy, Adventitious Agent Control, Modeling), technology development and commercialization enabled via a collaborative business model. He is actively engaged in the biotechnology community currently serving as a member of the PREP Scientific Advisory Cmte, Organizing Cmte for Recovery of Biological Products Modeling Workshops, Adjunct Professor at University of Delaware Department of Chemical and Biomolecular Engineering, and an ACS Councilor on the Meetings and Expositions Cmte, representing the BIOT Division. Dr. Roush previously served as session chair at PREP and ACS National Meetings (BIOT Division) and on the Northwestern University Master of Biotechnology Program Industrial Advisory Board for a decade, providing feedback on curriculum and mentoring graduate students. Dr. Roush has more than 30 years of experience in bioprocess development (proteins, natural products and vaccines) directly contributing to the development of five life-saving therapeutics including the natural product/semi-synthetic anti-fungal drug CandidasTM and the immuno-oncology antibody KeytrudaTM while a Distinguished Scientist at Merck BioProcess R&D. Specific examples include the development of both non-chromatographic and chromatographic purification processes for isolation and purification of an intermediate of CandidasTM which included an in situ solvent recovery step. Dr. Roush’s contributions to the development and commercialization of KeytrudaTM were honored with the ACS BIOT Industrial Biotechnology Award (2016) and ACS Heroes of Chemistry Award (2021). He was selected as an ACS Fellow in 2019 for his combined contributions to the advancement of the Chemical Sciences and associated impact to society as well as ACS. His experience spans process development for natural products, peptides, proteins, antibody drug conjugates from microbial, mammalian and fungal host spanning end-to end development from Discovery through Clinical Development and Commercialization including scale-up/scale-down and technology transfer. Dr. Roush was one of the pioneers in the development and use of computational biophysics models to support rational development of downstream processes and formulation development, which includes the application of Computational Developability. Dr. Roush has been actively engaged in advancement of scientific knowledge and the development of new technologies via collaborations with leading academic researchers and consortia (ex. NIIMBL, WuXi, Penn State, RPI, NC State) authoring more than 120 publications and presentations on the topics of primary recovery, adventitious agent control strategy and associated mechanisms, modeling and new technologies for hcp/lipase control. He received his Bachelor of Science degree in Chemical Engineering from Rice University and his PhD in Chemical Engineering from the University of Houston, under the guidance of Dr. Richard Willson. Dr. Roush’s doctoral research “Thermodynamic and Electrostatic Phenomena in the Ion Exchange of Proteins” was the synthesis of experimental and computational electrostatics and thermodynamics to explore protein-surface interactions, including the effects of charge variants and waters of hydration on chromatographic retention.

Anna Grönberg, Staff Research Engineer, joined Cytiva (formerly GE Healthcare Life Sciences) in 2003, and since then focused on the development of chromatography resins for capture and polishing of monoclonal antibody (mAb), and related applications. Throughout her career at Cytiva, Anna worked with several producers of mAbs and gained a thorough understanding on how modern technology and solutions enable more efficient biopharmaceutical production. As an expert in industrial mAb purification, Anna is currently dedicated to development of the new Fibro technology and related industrial applications as well as environmental sustainability aspects from an end-user perspective.

Cecilia Unoson works as a Principal Scientist at Bio-Works. She has been with Bio-Works for 6 years and her primary responsibility is application work focusing on customer purifications processes, especially involving so-called “TIDES” molecules (oligonucleotides and peptides). She has a PhD in molecular biology and a background in chemical Engineering.

Dr. James received his Ph.D. from the University of Delaware Department of Chemistry and Biochemistry in 1998 with a concentration in Organic Chemistry and Analytical Spectroscopy. During his time at the University, he was involved in the design and manufacture of high-pressure spectroscopy cells for investigations into the decomposition mechanisms of energetic materials using “T-Jump/FT-IR”, Pyrolysis/FT-IR, Mass Spectroscopy and Raman Spectroscopy. In 1994 he founded Supercritical Fluid Technologies Inc. and holds the position of President and Director of Technology. He is responsible for all research activities, including new product development and developing new applications for supercritical fluid techniques. The company has sought to fill niche markets by developing innovative solutions for demanding extraction, separation, and material processing needs using scCO2. In 2022 he established G-Flash, LLC as a technology and business development entity, focused on commercializing scCO2 Flash Chromatography (SFCTM) technology for the pharmaceutical Industry. GFCTM offers an alternative to the traditional solvent based Flash Chromatography that uses vast amounts of organic solvents for separations of pharmaceutical compounds.

Gregor Essert holds a bachelor’s and master’s degree in bioprocess engineering from the Technical University of Munich. Currently, he is a doctoral candidate at the Chair of Bioseparation Engineering at the same university, where he applies experimental and theoretical methods to study transport phenomena and surface interactions in ion chromatography. Additionally, Gregor is a founder of a startup project leveraging his expertise to develop software to accelerate downstream processing through proprietary mathematical models. This project is supported by the German Federal Ministry for Economic Affairs and Climate Action.

André Garcia holds a master’s degree in Analytical Chemistry from the University of São Paulo, Brazil, and a PhD in Food Chemistry from the University of Copenhagen, Denmark. Author and coauthor of 10 peer-reviewed papers, Dr. Garcia has more than 15 years of experience within research and education in life sciences. As a scientist at the Product & Application Development Group of Kromasil, by Nouryon, Sweden, he has been working on novel silica-based stationary phases, from their development to application. Among different projects, he has actively contributed to the development of preparative methods for the purification of GLP-1 receptor agonists

Currently PhD student at ETH Zürich, in the Separation Processes Lab led by Prof. Dr. Marco Mazzotti. He holds a Bachelor (2017) and a Master of Science (2020) both in Chemical Engineering, from Politecnico di Milano, Italy. His research activity deals with chromatography and crystallization process development.

After graduating as B. Sc. in 2003 at the RWTH Aachen University (Molecular Biotechnology), Johannes Buyel studied in Sweden (Lund University) and the USA (Fraunhofer Center for Molecular Biotechnology, Newark, Delaware) during his masters before joining the RWTH again for a PhD in 2009. His work focused on recombinant protein expression in plants and their purification, which Johannes continued to investigate as part of his post-Doc in 2013. Starting in 2014, he joined the Fraunhofer Institute for Molecular Biology and Applied Ecology IME as a group leader for model-based high-throughput bio-process development. In 2015 Johannes was promoted to head the department of Bioprocess Engineering (BPE), supervising process development and scale-up. In this position, he supervised projects focusing on the expression of challenging proteins (e.g. containing intrinsically disordered regions), the overall bioprocess integration (e.g. using side-stream biomass) and the modeling of manufacturing processes as well as their digitalization. In 2017 he received a second PhD in bioprocess engineering at the Karlsruhe Institute of Technology and successfully completed his habilitation in biotechnology in 2020 at the RWTH Aachen University. As of 2022, Johannes is a full professor for downstream process development at the University of Natural Resources and Life Sciences, Vienna (BOKU), where he continues to model, design and scale up processes in the context of plant molecular farming.

She was born on November 6, 1991, in Illertissen, Germany. Tanja attended the University of Ulm from 2011 to 2014, where she obtained her Bachelor of Science degree in molecular biology. She continued her studies at the University of Ulm from 2014 to 2017. During this period, she pursued a Master of Science degree in Pharmaceutical Biotechnology. As part of her studies, she had the opportunity to complete her master thesis (2016-2017) at BioVersys AG in Basel focusing on fighting multiresistant bacteria. In 2017, Tanja embarked on a Ph.D. and Post Doc journey at the University Hospital Ulm, working in the AG Seufferlein within the Internal Medicine department. Her doctoral thesis revolved around exploring the role of small extracellular vesicles (exosomes) in the propagation of inflammation after trauma. Since 2023, she has been working as a Post Doc at Boehringer Ingelheim. In the Bioprocess Development Biologicals division, her role primarily revolves around studying critical HCPs (Host Cell Proteins) in bioprocess development.

Oussama Menouar Menari Gheziel hold a B.Sc. in Biotechnology from the University of Granada (Spain) and an M.Sc. in Biotechnology from the Mannheim University of Applied Sciences (Germany) where he is currently doing research on the mAbs downstream processing as a phD candidate.

My name is Eric Denbaum and I am a 5th year PhD student in Steven Cramer's bio-separations lab at RPI. My work focuses on high throughput screening of chromatographic ligands for the purposes of process development and novel ligand discovery.

Pauline Bewosh hold a Bachelor's degree in Biotechnology from Mannheim University of Applied Sciences, Germany. Currently, she is pursuing my Master's degree, specializing in Bioprocess Development, also at the University of Applied Sciences. Her master's thesis focuses on examining the application of membrane chromatography for the capture and polishing of pDNA and the overall effect of salt on pDNA purification.

Joe Lavoie is a Senior Scientist at the Biopharmaceutical Manufacturing Training and Education Center (BTEC) at NC State University. Prior to this he was Post-Doctoral Researcher at NC State, a Product Development Engineer at Glen Raven, a fabric manufacturing company, and he worked at the US Army Natick Soldier Research, Development and Engineering Center. He has a Ph.D. and an M.S. in Chemical Engineering from NC State University and a B.S. in Chemical Engineering from Northeastern University."