Chairperson’s Opening Remarks

Advances In Cell Line Development And Process Development To Speed Mab And Non Mab Assets Faster To Clinic

Streamlining Early Cell Line Development to Increase Speed and Efficiency

Optimizing Cell Line Development with Beacon®: On-Chip Cloning Technology To Improve Performance And Reduce Timelines

Chairperson’s Opening Remarks

Overview of BioPhorum Raw Material Variability (RMV) Workstream

Digitization of Raw Material Data and The Application of Data Analytics to Better Understand and Control Variation

Chairperson’s Opening Remarks

Annex 1 Draft/Preventing Contamination and Cross Contamination during Aseptic Fill-Finish

Mitigating Particle Problems During Biopharmaceutical Formulation, Storage, and Use

Challenges And Complexities Related To The Development Of A Lyophilized Drug Product For An Acute Neurology Indication: A Case Study

Chairperson's opening Remarks

PAT in Freeze Drying - Measurement of Residual Moisture Content by Non-Invasive Methods

Using Raman Spectroscopy for Monitor and Control of Critical Quality Attributes in Ultrafiltration/Diafiltration of Biotherapeutics

Accurate Biomass Soft-Sensor Using 2-D Fluorescence and MARS Modeling

Chairperson’s Opening Remarks

Development of Tissue Therapies as compared to the Development of Cell and Gene Therapies: A Look Back, A Look Ahead

Raw Materials/Starting Materials

Cell Culture and Expansion

Chairperson's Opening Remarks

Single-Use Technologies for Cell & Gene Therapies

Data Science Tools for Accelerated Product Life Cycle

Anticipating Cell Lines Challenges for CMC Readiness

High Performance Accelerated Cell Line Development at Samsung BioLogics

Consistently Delivering Outperforming Cell Lines Leveraging Extensive CLD Expertise and Innovative Seeding Platform

Understanding and Controlling the Impact of Elemental Impurities in Cell Culture

Media Raw Material Variability: Case Studies in Different Stages of Product Lifecycle

Syringe Filling of a High-Concentration mAb Formulation: Issues and Mitigation Strategies

Feasibility of Frozen BDS Storage Of Ultra-High Concentration mAbs

The Effect of Surfactant Excipients on the Stabilization of Proteins during Mechanical, Oxidative and Thermal Stress

Real-time titer measurement methods to control Protein A column loading during continuous antibody production - a technology overview

Evaluation of PAT Co-Laboratory Process Development Model

Cell Culture and Expansion

Scaffold Fabrication - 3D Printing

Biomaterial Scaffold Fabrication - Additive Manufacturing Materials and Methods

Single-Use Technologies for Cell & Gene Therapies

Data Science Tools for Accelerated Product Life Cycle - Cont'd

Accelerating Timelines through Implementation of TLA Sequencing in Cell Line Selection

Further Streamlining CLD: Combining Single Cell Cloning and Enrichment using FACS into Semi-Solid Media

Trypan Blue vs. Dual-Fluorescence Nuclear Stains: Systematic Experimental Design for Cell Concentration and Viability Method Selection

Raw Material Control Strategies: From User Requirements to Design of Specifications

Development of A Holistic Approach to Raw Material Risk Assessments Through Industry Collaboration

Qualification of Raw Material for Clinical Trials

Overcoming Challenges in Developing Subcutaneous Formulations for Biologics

Challenges and Strategies for Low-Dose Drug Product Development During In-Use Administration Studies

Cyclodextrins as a functional alternative to polysorbates within biologic formulations.

Enhancing Process Optimization Using Advanced Analytical and Data Handling

Development and Implementation of a PAT System in GMP for Real-Time Manufacturing Process Monitoring and Control

Investigating USP & DSP Tools For Analysis: Round Table:

Scaffold Fabrication Using 3D Printing

Tissue Maturation and Bioreactor Culture

Tissue Maturation and Bioreactor Culture

Single-Use Technologies for Cell & Gene Therapies

Data Science Tools for Accelerated Product Life Cycle - Cont'd

Panel Discussion: Integrating New Engineering and Cell Line Development Technologies into Established Workflows

From Sequence to Product in Hours - Cell Free Expression for Next-Generation Therapeutics

End of Symposium

In Pursuit of Robust Drug Product Manufacturing Process for mAbs

End of Symposium

Smart Data Analytics for Biomanufacturing Process Modeling and Advanced Process Control

End of Symposium

Magic on Ice: Ice-free cryopreservation at high-sub zero temperature for advanced CGT processing

Process Development Through multiomic platform

Data Management and Process Optimization Software

Single-Use Technologies for Cell & Gene Therapies

Data Science Tools for Accelerated Product Life Cycle - Cont'd