Agenda

Opening Session

• Introduction

  Introduction and Welcome

  Chair of the Scientific Committee & Organizing Committee

• Inspiring Talk

  Developing gene therapy with no plan B: A mother's journey from diagnosis to first-in-human

  Špela Miroševič, CTNNB1 Foundation

• Inspiring Talk

  Tackling the Tough Topics: From Diagnosis & Treatment To Driving & Prevention and Advanced Directives

  Mateja de Leonni Stanonik, VitaMedica Institute

• Inspiring Talk

  The treatment of cardiovascular diseases in new era of medicine – the experiences of International center for cardiovascular diseases MC MEDICOR Slovenia

  Marjeta Zorc, MC MEDICOR; Medical Faculty, University of Ljubljana

• Special Address

  Fostering Regional Innovation & Collaboration

  Tadej Beočanin, Mayor of Ajdovščina

Plenary Sessions & Expert Insights

• Plenary Session

  Advancing biomanufacturing education: adapting workforce development for the next generation of biologics

  Gary Gilleskie, Biomanufacturing Training and Education Center

• Expert Insights

  Oligonucleotide Aptamers; Past and Future

  Chizuko Koseki, TAGCyx Biotechnologies

• Expert Insights

  Rational design of lipid nanoparticles using impingement jets mixing (IJM) technology

  Nadia Elghobashi-Meinhardt, Knauer

• Plenary Session

  Re-engineered stable AAV producer cell lines for high productivity and quality attributes

  Ines do Carmo Goncalves, Cytiva

Plenary Sessions & Expert Insights

• Plenary Session

  Digital twins of disease evolution to understand disease and its treatment ahead of time

  Janez Štrancar, Infinite

• Expert Insights

  Early stage preclinical development of new biological pan-antiviral

  Uroš Andjelkovic, SavantiVir

• Expert Insights

  Gene transfer with polymeric nanoparticles for ocular disorders

  Niren Shah, Cove Therapeutics

• Plenary Session

  Gene Editing and Delivery Breakthroughs: Overcoming therapeutic barriers for unmet needs

  Thomas Cradick, Gene Editing Frontiers

RNA Therapeutics: From Vision to Clinical ApplicationsNucleic Acids and LNPs

• The RNA revolution: from novel vaccines to therapeutic genome editingonline

  Dan Peer, Laboratory of Precision Nanomedicine, Tel Aviv University

• Purification Strategies of Circular RNAonline

  Linpeng Wu, RiboX

• mRNA gene electrotransfer of IL-12 in melanoma and colorectal carcinoma: From in vitro characterization to in vivo antitumor efficacy

  Urban Bezeljak, COBIK

• Multi-column chromatography for in situ production and purification of mRNA

  Mark Stoops, Biomanufacturing Training and Education Center

Plasma ProteinsProteins

• Plasma fractionation - Past, present and future

  Albert Farrugia, The University of Western Australia

• Beyond the Cohn Process: Novel Approaches to Overcome Bottlenecks in Plasma Fractionation

  Aleš Štrancar, BIA Separations Inc

• Commercial-Scale Evaluation of a CIMmultus® Mixed-Mode Monolith for IgG Production

  Andre Germishuizen, National Bioproducts Institute

• Purification of FIX from Cryopoor Plasma using DEAE and SO₄ Monolithic Supports

  Lucija Dončević, Genos

The Future of Gene Therapy: AAV Platforms and Clinical TranslationViruses and Viral Vectors

• A Long-Term Perspective on AAV Gene Therapy

  Robert Kotin, Massachusetts Institute of Technology

• Characterization and release testing of AAV-based products for clinical use – where are we?

  Jaap Twisk, UniQure

• Impact of Genome Fragmentation and Empty Capsids on rAAV Functional Potency in Liver Cells

  David Dobnik, National Institute of Biology

• Universal AAV Standard: Advancing Standardization in AAV Genome Quantification and Quality Assessment

  Andrzej Noyszewski, VerumGen Labs

Next Generation Manufacturing PlatformsNucleic Acids and LNPs

• Enzymatically Synthesized DNA Templates Enable Scalable mRNA manufacture and Robust PolyA Tail Integrity

  Stella Kounadi, 4basebio

• iCAP: Integrated Continuous and Automated Platform for Plasmid Production

  Juergen Mairhofer, enGenes Biotech

Plasma ProteinsProteins

• Efficient and Scalable Purification of Plasma derived Therapeutic Proteins

  Yow-Pin Lim, ProThera Biologics, Inc

• Direct chromatographic capture of therapeutic proteins from undiluted human plasma on large channel monoliths

  Tomislav Friganović, Genos

Novel Downstream Processing TechnologiesViruses and Viral Vectors

• Interferon-inducing viral vector immunotherapy reprograms tumor immunity and eliminates persistent HPV infection

  Thomas Muster, BlueSky Immunotherapies

• Ex tempore Oncolytic Virus Manufacturing: A Feasibility Assessment

  Beata Halassy, University of Zagreb

Interactive Workshop

• Interactive Workshop

  The Value Creation Experiment: Exploring how sustainability can become our next competitive advantage

  Simone Dimartino, Planet Crafting Labs

Plenary Sessions & Expert Insights

• Plenary Session

  Don't trust AI - audit it: Why regulated science is uniquely ready for AI

  Anže Videnič, BioSistemika

• Expert Insights

  GlycanAge - a tool for personalized health tracking

  Dora Lalić, GlycanAge

• Expert Insights

  ADAscape™: High-Resolution Epitope Profiling for Anti-Drug and Anti-Vector Antibodies

  Oskar Smrzka, Ablevia

• Plenary Session

  AI-Driven Digital Twins for Accelerating Chromatographic Purification and Analysis of mRNA Lipid Nanoparticles

  Rob Rodick, Ayagence

Plenary Sessions & Expert Insights

• Plenary Session

  How can commercially promising scientific results be safeguarded?online

  Hans-Wilhelm Meyers, Dompatent

• Expert Insights

  Advancing Formulation Development with ZetaView® Evolution NTA: High-Resolution Analysis of Lipid Nanoparticles and Viral Vectors

  Christina Klasen, Particle Metrix

• Expert Insights

  Enabling the Future of Gene Therapy: Innovations to Improve Scalability, Quality, and Cost per Dose

  Ines do Carmo Goncalves, Cytiva

• Plenary Session

  From the Bench to Investor-Ready Intellectual Property: Why Strong Science Is Not Enough

  Olga A. Partington, Sterne, Kessler, Goldstein & Fox P.L.L.C.

Purification of Nucleic AcidsNucleic Acids and LNPs

• The use of Mustang Q membrane chromatography as the capture step in a 2-step plasmid DNA purification strategy

  Aydin Kavara, Cytiva

• Applied chromatography technologies and analytical applications for preparations of ultra-pure minicircle plasmid DNAs

  Kevin Ainger, GaletaBio

• Simultaneous development of chromatographic monoliths and purification methods to overcome bottlenecks in downstream processing of large nucleic acids

  Urh Černigoj, Sartorius BIA Separations

• Evolution of Vaccine Technologies: From Recombinant Vaccines to pDNA and mRNA Platforms

  Mukesh Chauhan, BioNet Asia

Next-generation BioprocessingProteins

• Chromatography on newly developed monolithic supports for biological nanoparticles and large biomolecules

  Djuro Josić, Faculty of Medicine, Juraj Dobrila University

• Technoeconomic and sustainability evaluation of 3D printed monolithic adsorbers for integrated clarification and capture of therapeutic antibodies

  Simone Dimartino, University of Edinbourgh

• Monolith-based immobilised enzyme reactors: enabling technologies across evolving analytical and biotechnological landscapes

  Manuela Bartolini, University of Bologna

• Advanced fluorescence microscopy platforms for imaging of (biological) samples at various spatial and time scales

  Boštjan Kokot, IJS

Manufacturing & Analytics of Viral TherapeuticsViruses and Viral Vectors

• Curative Gene Therapy for Hypophosphatasia and Thrombotic Thrombocytopenic Purpura

  Wolfgang Schönfeld, A-SpecTar

• From viral complexity to clinical manufacturing: a platform approach for cancer immunotherapies

  Binod Prasad, Abalos Therapeutics

• Affinity and mixed-mode convective adsorbents for the purification and enrichment of vectors for cell and gene therapies

  Stefano Menegatti, North Carolina State University

• Evaluation of PrimaS and PrimaT Monolithic Chromatography Columns for Purification of Therapeutic Bacteriophages Targeting ESKAPE Pathogens

  Danish J. Malik, Loughborough University

Next Generation Manufacturing PlatformsNucleic Acids and LNPs

• YRC

  Development of scalable purification strategy for minicircle DNA vaccines in different monoliths

  Rafaela Gaspar, Universidade da Beira Interior

• YRC

  Scalable purification of a DNA-launched RNA replicon-based vaccine candidate against Trypanosoma cruzi infection using monolithic chromatography technologyonline

  María Alicia Delfino, LITAN, CONICET - UBA

Novel Tools and Technologies for Protein ScienceProteins

• YRC

  A combined 3D printing–phase inversion process as a new platform for monolith production

  Gabriele Malagoli, University of Bologna

• YRC

  From Hours to Minutes: Development of an Oriented PNGase F IMER for Automated Glycoprofiling

  Wendy A. Mensah, University of Bologna

Viral Vector EngineeringViruses and Viral Vectors

• AE1-BHK: A Novel E1-Complementing BHK Platform for Recombinant AAV Production

  Andrzej Noyszewski, VerumGen Labs; Agathos Biologics

• YRC

  Engineered recombinant baculoviruses for efficient production of enveloped virus-like particles

  Martina Lokar Kosmač, COBIK

Plenary Sessions & Expert Insights

• Plenary Session

  Fundamental growth milestones and positioning for a high value strategic exit

  Evan Yellin, Cory Kenny, Raffaele Bonavitacola, EC M&A

• Expert Insights

  Scaling the future: the evolution of ATMP facility design from Boutique labs to Flexible Manufacturing Platforms

  Matej Štupar, Katezai

• Expert Insights

  NeoVac: Building the Next Generation of RNA Delivery

  Denis Bešić, NeoVac

• Expert Insights

  Purity and Composition: How Reference Standard Quality Impacts dsRNA Quantitation in mRNA Drug Productsonline

  Jamison Grailer, Promega

• Plenary Session

  Beyond the sequence: how intended use shapes the regulatory pathway

  Florence Salmon, Roche

End to End LNP ManufacturingNucleic Acids and LNPs

• A comprehensive manufacturing and characterization approach to passive or active targeted LNP-based biopharmaceuticals

  Tristan Kovačič, Sartorius BIA Separations

• Monolith liquid chromatography for recovery and purification of intact lipid nanoparticles shows full in vivo compatibility

  Sven Even Borgos, Sintef Industry

• Advanced quality control strategies for mRNA nanoparticles

  Heinrich Haas, NeoVac

• Enabling Scalable Chromatography from Analytical to Preparative Purification for LNPs

  John McHale, Arcturus

Future TherapeuticsProteins

• Proteinaceous pan-antiviral entry inhibitor for crossing the gap in pandemic preparedness

  Uroš Andjelkovic, SavAntiVir

• Applications of highly functional Xenoligo ssDNA aptamer technology for medical and bioprocessing

  Miyuki Hori, TAGCyx Biotechnologies

• Finding the Golden Site: how synthetic amino acids and third-generation click-chemistry enable the next generation of protein conjugates

  Maximilian Winkler, VALANX Biotech

• Precision Management of Anti-Drug and Anti-Vector Antibodies: Deep Epitope Profiling and Adaptable Molecular Decoys for Selective ADA Removal

  Oskar Smrzka, Ablevia

Emerging non Viral and Viral Delivery PlatformsViruses and Viral Vectors

• Programmable Virus-Like Particles for Targeted Drug Delivery

  Vera Schoft, A-SpecTar

• Native Elution Immunoaffinity Chromatography for Efficient Purification of Vesicular Stomatitis Virus

  Adela Štimac, University of Zagreb

• Non-viral, polymeric nanoparticle gene therapy for ocular disorders

  Jordan Green, Cove Therapeutics

• nanoSFERIC™: A Novel Flexible Nanoparticle Vaccine Platform for Infectious Disease and Cancer

  Matjaž Peterka, Sferogen

End to End LNP ManufacturingNucleic Acids and LNPs

• Chromatographic LNP purification for enhanced purity and activity in CRISPR, CAR-T, and vaccine manufacturing

  Mojca Tajnik Sbaizero, Sartorius BIA Separations

• tLNP as a Novel Gene Therapy Vector to Deliver DNA

  Jacek Lubelski, NanoCell

• End to End Lipid Nanoparticle Workflow; From Formulation to Large Scale Manufacturingonline

  Aslan Dehghani, Sartorius

HTR, AI, and Digital Twins in BiopharmaProteins

• Closing the Target-Validation Gap for Complex Biologics with an Integrated AI Knowledge Platform

  Konstantin Glebov, University of Plymouth; Exosome Consulting

• A general, biologically-interpretable image analysis pipeline for microscopy of pharmaceutical agents in biological systems

  Hana Kokot, IJS

• High-Throughput IgG Glycosylation Analysis Using Protein G Monoliths

  Irena Trbojević Akmačić, Genos

Extracellular Vesicles: Manufacturing, Characterisation and Therapeutics PotentialViruses and Viral Vectors

• Long and winding road to scalability and clinical viability of Extracellular Vesicle–based therapies

  Nataša Zarovni, RoseBio

• From consistent manufacturing to understanding mechanisms of action (MoAs) for extracellular vesicles from MSC

  Klaus Graumann, Phoenestra

• Harnessing Nature's Nanoparticle: Process Development of Exosomes for Drug Delivery

  Lior Shaltiel, NurExone Biologic