This keynote explores the transformative potential of digital innovation and sustainability in shaping the future of biomanufacturing. It examines key considerations for establishing efficient, GMP-compliant facilities at production scale, utilizing novel single-use technologies. The discussion will highlight advancements and emerging trends in biomanufacturing.

• A journey of how different team work together to make quick biotech product launch
• Tips on choosing different product classification, regulatory pathway
• Tips on manufacturing setup
• Tips on market expansion

The need for higher productivity, lower COGs, smaller footprint and more complex molecules is driving bioprocess manufacturing towards process intensification. We demonstrate in two case studies how intensified processes, namely small-scale perfusion mimic and high inoculation fed batch, were incorporated into cell line development. Hereby, not only productivity and titer were significantly increased, but also top clone selection was adjusted to the requirements which cutting-edge production processes impose on a cell line. Aim was to identify clones which are "fit for future" advanced bioprocess manufacturing.

• Setting expectations from the outset to ensure clear communication of timelines
• How can you create trust with both parties to ensure a successful working relationship?
• Key pitfalls and successes
• Choosing the right partners

The use of Raman spectroscopy as a PAT solution is showing many tremendous opportunities for real time process monitoring capabilities. Historically, the most challenging part of implementing Raman spectroscopy as a PAT solution for real time process monitoring is establishing the chemometric models to monitor the cell culture critical process parameters and critical quality attributes. This chemometric model building process would require multiple batches (4-5) and data points (50-70). During this talk, I will be sharing recent breakthrough of a proprietary and simplified one batch calibration method to easily establish the whole process of chemometric model building

• Regulatory Requirements and Definitions
• Investigation Tools for Root Cause Analysis
• Problem Solving Options for CAPA and Evaluation for Effectiveness Check
• Suggestions for handling Deviations and CAPAs

Critical quality attribute of MSCs is sustained homeostatic replication and those of iPSCs are self-renewal and differentiation susceptibility. Since quality fluctuation of stem cells is primarily caused at culturing, their expansion has long been undertaken by skilled and experienced staffs with large efforts and labors. Simple automatization would not be their solution since process monitoring and analyzing are indispensable to secure quality of unstable stem cells. We have applied CellQualia Intelligent Cell Processing (ICP) System, a fully closed cell manufacturing instrument with process analytical technologies, to both MSCs and iPSCs and compared their quality with those from manual operation. The results showed the quality comparability of the cells from automated and manual expansion. On the other hand, only ICP System enabled us to monitor and record cell manufacturing process as numerical indexes. The data thus obtained is expected to be used in applying Quality-by-Design concept to manufacturing of those cells and base for their in-process qualification. We hope the results of our study would be cue for shifting from manual to automated cell manufacturing at practical level.

Cell culture and microbial cultivation processes are complex and difficult to control, because of the biological variability and many process parameters which also interact. The results are batch to batch variations, batch failure and missing economy. However MC process understanding must be demonstrated in regulatory filing, which is currently targeted by many explorative experiments using DoE. This contribution demonstrates the usefulness of process modelling and the deployment of the models as digital twins for process optimization and achieve process robustness. We will show,

• How process models can be set up using a good modelling practice workflow
• How digital twins are used to optimize feeding strategies by model-based design.
• Which data architecture is needed to deploy digital twins in real time?
• How to achieve robustness and optimized process conditions by digital twin-based feedback control?

Culture culture media optimization plays a vital role in bioprocess development. Achieving an optimal formulation for the culture media is crucial as it enables maximum cell growth and subsequently yields the highest possible cell density. The current workflow involves experimental Design of Experiments (DOE) to determine the optimal culture media formulation. A paradigm shift is underway in the optimization of culture media, wherein a modelling approach can be employed to accelerate culture media optimization. In this talk, I will introduce a computational approach involving genome-scale metabolic modelling and model-guided DoE approach, and how this workflow can help the industry, particularly for new modalities, to accelerate culture media design and optimization.