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Friday 21st March - Main Conference Day Three - PT (Pacific Time, GMT-08:00)
One of the most time-consuming and tedious aspects of pre-clinical program development is clone screening for a production cell line. Automation tools allow efficient execution of these activities as well as timeline reductions to meet the demands of next generation modalities. Here, we will discuss a toolset that enables end-to-end automation for clone screening timeline optimization and execution.
- Landon Mott - Process Development Principal Scientist, Amgen Inc.
- Risks of accelerating the CLD timeline;
- Associated methods to perform early screens for stability.
- Allyn Spear - Principal Research Scientist, Cell Line Development Lead, Elanco Animal Health
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- Explore strategies to improve yield and titer for CoG reduction;
- Learn about the connection between CoG reduction and sustainability;
- Gain practical examples and insights from industry case studies.
- Frank Ritacco, PhD - Senior Director, Cell Culture Development, Regeneron
- Maddie Andres - Scientist, Pfizer
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This presentation addresses key concerns surrounding the successful implementation of automation in cell therapy manufacturing. It explores strategies for simplifying the integration of cell therapy equipment, both through digital systems and robotics. Additionally, it explains how enhanced integration capabilities improve system robustness while reducing costs and risks for both vendors and customers. The presentation also highlights the importance of balancing standardization with innovation, drawing on historical examples from biotech and other industries to illustrate best practices.
- Semsi Ensari - Sr Director, Process Development, Kite Pharma
- Neal Schilling - Director – Manufacturing, Compass Therapeutics
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- Managing resin saturation and desaturation cycles when implementing a continuous processing approach within downstream;
- Can upstream and downstream operations be combined for a seamless workflow?
- Utilising PAT for real-time data and process control throughout production;
- Case-study examples and data: how has continuous been implemented and what happened?
- Aishwarya Ramanan - Scientist MSAT Labs & Innovation, Pfizer (Legacy Seagen)
Technological hurdles and challenges associated with implementing an intensified or continuous approach:
Equipment design
Process Control
Consistent product quality
Cost-benefit viability of continuous processing: potential for reduced costs, increased production, expedited time to market
Regulatory landscape for continuous manufacturing:
Navigating approval process
Implementing new approach into existing processes effectively
Case study examples, real world lessons
Future outlook of continuous in the biopharm industry: driving adoption
- Stefano Menegatti - Associate Professor, North Carolina State University
- Justin Skoble - Vice President, Caribou Biosciences, Inc.
- Jitendra Kumar - Lead Scientist - Chemistry & Process Development, Entos Pharmaceuticals Inc., USA
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Recombinant CHO cell lines often show improved growth in late generations, but the molecular mechanism is largely unclear. In this study, integrated genomic and transcriptomic profiling was performed on multiple Pfizer cell lines with different CHO host and monoclonal antibodies. We found the duplication of a continuous 50.2 Mbp segment in chromosome 2 (Chr2) correlated with the gain of improved growth phenotype. Yet such chr2 duplication was absent in clones without age-correlated growth change. In-depth mechanistic studies are ongoing to facilitate biomarker-based cell line screening and rational cell line engineering.
- Wei Wei - Senior Principal Scientist, Pfizer
Balanced chain expression is crucial for achieving high productivity and proper assembly of multi-chain bispecific molecules. In this talk, we will present a case study demonstrating how vector design and selection methods impact the titer of correctly assembled molecules. Additionally, we will discuss clone diversity and single cell cloning strategies.
- Bin Fan, PhD - Director of Biologics, NGM Biopharmaceuticals
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- Advances in automation and real-time analysis for biologics manufacturing;
- Raman spectroscopy and its application in bioreactors
- Real-time protein analysis;
- Case studies on improving efficiency and reducing production timelines.
- Rahul Pradhan - Associate Director, Cell Culture Platform, Sanofi
- Yashas Rajendra Ph.D. - Associate Director & Principal Scientist, Denali Therapeutics
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- Optimizing technologies for efficient biomanufacturing of Antibody Drug Conjugates (ADCs)
- Scaling up production for commercial and clinical supply
- Investing in cutting-edge facilities and equipment to meet growing demand
- Developing innovative process improvements for greater flexibility and cost-effectiveness
- A Representative - From, Sutro Biopharma, Inc.
Cardiotoxicity is the leading cause of drug failure during pharmaceutical development. It also significantly impacts medical device and therapeutic development due to the complexity of heart function and the inability of regeneration of heart tissue. Engineered heart tissue (EHT) derived from hiPSCs has become an indispensable research tool in the past decade. With the increasing use of this in vitro testing model for internal decision making at pharmaceutical companies and the recent release of the FDA Modernization Act 2.0, there is an emerging need for scalable platform that can reliably produce and characterize EHTs. To address this issue, a high throughput in vitro testing platform and the associated accessories are developed to fit the industrial standard 96-well plates. With the current collaboration between BU and FDA's CDER, the prototype system will be evaluated and refined according to the FDA framework. Successful technology transfer of this innovation will help the industry and the regulatory to establish a standard guideline in using EHTs for all types of bioprocessing.
- Marshall Ma - Research Fellow, Boston University
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The use of affinity tags is generally considered a non-starter for the purification of biopharmaceuticals clinical use. New developments in this field, including self-removing tags and optimized protease enzymes, have eliminated some of the technical and economic barriers to these methods. This talk will focus on one major remaining concern, which is how to develop validated release assays for characterizing products that are manufactured using cleavable tags. Several options will be discussed, along with preliminary data on several approaches.
- David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University
Rapid advancement to manufacturing is crucial for AAV gene therapies, yet downstream processes frequently present a significant bottleneck. To address this challenge, MeiraGTx has established a high-throughput toolbox that integrates microscale screening platforms with a novel affinity HPLC method for in-process sample analysis. These high-throughput techniques are supported by automated digital workflows, effectively streamlining and accelerating the process development pipeline.
- Marion Jenny - MSAT Senior Scientist (DSP), MeiraGTx
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- Dan Oliver - CEO and Founder, Rejuvenate Bio, USA
- Nick Timmins - CSO, Syntax Bio
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- Steven Oh, PhD - Deputy Director, Office of Cellular Therapy and Human Tissue CMC, Office of Therapeutic Products, CBER, FDA