Wednesday 19th March - Main Conference Day One - PT (Pacific Time, GMT-08:00)
- Eeshit Vaishnav - CEO, Sequome
- Hui Xiao - Associate Director, Regeneron
- Dawn Eriksen-Stapleton, PhD - Principal Scientist, Pfizer
We present a novel pilot-scale benchtop system that can run almost all major downstream purification processes, such as chromatography, tangential flow filtration (TFF), SPTFF, normal flow filtration, inline dilution, and various process intensifications (4C) and integrated processes. This platform features its powerful multi functionality with three key innovative process configurations and modular concept as well as a comprehensive industrial DCS control and data management framework in line with digital transformation. The system represents a transformative shift in bio pharmaceutical downstream processing and can play a critical POC role for tech transfer.
- Zuwei Jin - VP Business Development, Lisure Technologies
- Manuel Carrondo - Vice-President, Instituto de Biologia Experimental e Tecnológica
- Kate Rochlin - Chief Operating Officer, IN8bio
The biopharmaceutical industry faces increasing pressure to produce a wide range of therapeutics quickly, with high yields and consistent quality. Lonza helps companies meet these demands with integrated solutions that streamline the entire drug development process. By combining cutting-edge expression technology, efficient CHO media systems, and expert biologics services, we support drug developers and producers from late-stage discovery all the way to commercial supply.
At the core of our solutions is the proven GS® platform, designed to deliver high-yield, scalable, and stable expression for a broad range of biotherapeutics. With this platform, we help you optimize the expression of your molecule, whatever its type, helping to reduce time to market.
Supporting this, the TheraPRO® CHO Media System offers a chemically defined, non-animal origin (NAO) formulation, solution engineered to maximize protein yield and ensure scalability across research and manufacturing stages. Its advanced formulation delivers consistent performance and simplifies workflows, backed by proven performance for modern bioprocessing needs.
Lonza’s biologics services further offer end-to-end solutions for any molecule type. These services encompass drug candidate selection & optimization, process development, clinical and commercial manufacturing, and regulatory support, helping customers reach the clinic and market faster.
In this talk, we'll cover how our proven GS® platform, CHO media, and expertise in biologics enable biopharmaceutical companies to efficiently bring scalable, high-quality therapies to market, transforming scientific innovation into life-changing treatments for patients.
- Sanjay Kumar - Head of Technical Excellence, Media Solutions, Lonza Bioscience
- Eeshit Vaishnav - CEO, Sequome
- Strategies To Balancing Chain Ratio and Assembly Issues To Maximise Formation of Fully Formed Multispecifics;
- Solutions for preventing light chain swapping;
- Analytical techniques to screen and ensure proper chain pairing;
- Case studies on successful mitigation of chain mismatching issues;
- Can transposons give a better ratio?
- Vector design strategies? Promoters? - Explore innovative strategies for optimizing expression vectors, with a focus on chain ratio modulation;
- Keep product impurities to a minimum;
- Strategies to navigate longer timelines and additional assays required for multispecifics;
- How to reduce aggregation of product within the cell? Bioreactor conditions? Engineering?
- Eva Rubio-Marrero - Senior Scientist II, AbbVie
- Cynthia Lam - Technical Development Scientist, Genentech
Cas-CLOVER is an advanced alternative to CRISPR/Cas9 that provides numerous technical and commercial benefits. Notable advantages include enhanced targeted integration efficiency, larger transgene cargo capacity, and superior commercial freedom to operate (FTO) profiles within CRISPR-based genome editing.
The targeted integration strategies employed by Cas-CLOVER for cell line development (CLD) offer significant benefits compared to plasmid or transposase delivery systems. Unlike CRISPR/Cas9, which exhibits low knock-in efficiency and restricted transgene size delivery capacity, Cas-CLOVER addresses these limitations. The suboptimal outcomes associated with CRISPR/Cas9 may be attributed to its blunt-ended cutting mechanism and/or monomeric nature, which lead to undesirable off-target effects and translational inconsistencies.
Our data demonstrates that Cas-CLOVER, leveraging an enhanced dimeric CRISPR-based system and the proprietary nuclease Clo051, achieves threefold higher targeted knock-in efficiencies and supports transgene cargo capacities of at least 20 kb. This evidence underscores Cas-CLOVER's potential to transform CLD, enabling the expression of complex molecules, including bi- and tri-specific antibodies, with greater precision and efficiency.
- Corey Brizzee, PhD - Director of Gene Editing, Demeetra
- Joseph Kwon - Associate Professor, Chemical Engineering, Texas A & M University
- Neil McCracken, PhD - Principal Research Scientist, Upstream Process Development, Group Leader, Elanco
- Alexandria Triozzi - Technical Development Engineer III, Biogen
- How CDMOs have evolved in the last 5 years and what to expect in the coming years;
- Geopolitical uncertainty and its impact on outsourced manufacturing;
- Collaboration to understand the changing needs of pharma and biotech.
- Vadim Klyushnichenko - VP Bio/Pharmaceutical Development & Quality, Calibr-Skaggs Institute for Innovative Medicines
- Lihua Yang,PhD - Senior Principal Research Scientist, AbbVie
- Andrew Harmon - Associate Manager, Management & Strategy Consulting, Sia Partners
- Kevin Zen, PhD - Senior Director, IGM Biosciences, Inc.
- Lori Ball - Chief Executive Officer, Astoriom
- Younghoon Oh - Senior Scientist, API Protein, Johnson & Johnson Innovative Medicine
Depth filters are widely used in the biopharmaceutical industry. They are typically made of a mixture of cellulose, filter aids, and a binder. These components can be milled and mixed in different ratios to target a wide range of pore sizes. The complex nature of the raw materials gives each filter a relatively broad pore size distribution and provides some adsorptive capacity through charge and hydrophobic interactions. The filter media thickness, pore size distribution, and adsorptive capacity make them the ‘go-to’ technology in harvest applications where a product is separated from a complex cell culture fluid.
Recent work has highlighted the importance of how flow distributes within single-use capsules, and how capsule design can affect scalability. In this work, we take a deep dive into flow distribution through depth filter capsules using a combination of CFD modeling and experimental work. CHO cell culture streams, both direct and post-centrifugation, are used to assess performance parameters such as capacity, impurity removal, and yield. We will also present scalability data across a full range of process development-scale, pilot-scale, and manufacturing-scale depth filter capsules. This data will help process development scientists and engineers understand the structure of these devices, what parameters to focus on during development, and how to set appropriate safety factors during scale-up.
- Luke McCarney - Filtration Engineer, Cytiva
- Manuel Carrondo - Vice-President, Instituto de Biologia Experimental e Tecnológica
- Kendall Feshuk - Global Head, Membership Development & Solutions, Rx-360, USA
- Hui-Lan Hu - Associate principle scientist, AstraZeneca
- Yuansheng Yang - Senior Principle Scientist 1, A*STAR
- Larry Forman - CEO, CHO PLUS
Novel modalities propose unique challenges for their purification and removal of impurities - how can purification processes be optimized for these novel modalities?
- Downstream processing considerations for modalities such RNA-based-therapies, T-cell engagers, CGTs.
- Key challenges in purification, scaling, and quality control.
- Innovative solutions and strategies for optimizing these processes.
- Jolene Ignowski, Ph.D - CMC Project Lead, Bayer
- Maher Alayyoubi - Senior Principal Scientist - RNA Technology and Innovation, Arcturus Therapeutics
- Alpana Naresh, Ph.D. - VP, CMC Manufacturing, Hinge Bio, Inc.
- Amy Shaw - Head of Process and Product Development, Cell Therapy Sciences, Takeda, USA
- Jose Vidal - CEO, CytoImmune Therapeutics Puerto Rico, LLC
- Dan Stanton - Editorial Director, Informa Connect Life Sciences