Agenda March 17, 2027: Main Conference Day OneWednesday, 17 March 2027 - PT (Pacific Time, GMT-08:00)

• Media and feed composition play a significant role in shaping CHO cell growth and productivity
• Optimizing nutrient supply can improve productivity without compromising product quality
• Cross-project and cross-scale learnings enabled informed nutrient management strategies and reduced reliance on empirical optimization

• Combination of automation and mechanistic modeling enables efficient acceleration of purification (even for challenging molecules)
• Mechanistic modeling facilitates transfer between non-clonal and clonal cell lines as well as tech transfer to pilot or manufacturing-scale
• Nanofiltration conditions can be optimally screened using automated DLS to enable challenging filtration, such as for hydrophobic molecules

• Intensified Harvest and Salt-Tolerant Capture Strategies
• Employing targeted analytics to track, identify, and quantify problematic host cell proteins across challenging purification stages.
• Predictive In-Silico and Mechanistic Modeling

• The high-throughput VRF platform supports rapid evaluation of filtration performance across a broad range of process parameters, including feed stream pH, excipient concentrations, and protein concentration
• High-throughput approach can reduce both time and resources required to develop VRF
• The high-throughput VRF platform can be readily implemented to identify relevant design space for process optimization and for assessing the suitability of biologics candidates for platform purification processes.

Platform-versus-custom is one question asked in nearly every track - CLD, upstream, and downstream all separately arrive at how far standard platforms and standardized approaches can stretch before a molecule demands something bespoke. Rather than three parallel, overlapping conversations, this panel brings CLD, upstream, and DSP leaders together to compare where platform still creates major speed and efficiency benefits, where it introduces hidden constraints, and how teams decide when to customize, including where standardization tradeoffs look different across cell line design, upstream process development, and downstream purification. It is a strong bridge between technical work and strategic portfolio decisions.

• High concentration formulations are required to provide the therapeutic dose by subcutaneous injection for a wide range of biopharmaceuticals, including monoclonal antibodies and small interfering RNA.
• This talk will highlight the underlying physical phenomena that create challenges in formulating these products by ultrafiltration, including high viscosity and membrane fouling
• Several novel strategies will be presented for achieving highly concentrated biopharmaceuticals, including the use of vibratory assisted ultrafiltration and forward osmosis

Technical and non-technical causes of delay: GMP slot shortages, assay failures, process surprises, transfer friction, short stability windows, comparability hurdles, documentation burden, data governance, definition of holistic control strategies, and organizational silos, including the fact that review and inspection timelines themselves have become less predictable, which changes how much schedule float a program can safely assume. This panel will help prioritize the most avoidable sources of delay.

This forward-looking panel will separate meaningful next steps from hype in cell and gene therapy manufacturing. It will focus on the technologies and workflow changes most likely to materially change advanced therapy manufacturing over the next five years, including industrialization, in vivo delivery, automation, and data governance, and press panelists on what is actually deployable at scale versus still aspirational. The emphasis should be on practicality and what will actually change patient access.