Pre Conference Focus Day

Tuesday, February 13, 2024

9:00 am Chair’s Opening Remarks

Characterizing the Target Protein for Regulatory Approval & Ease of Formulation

9:15 am Fireside Chat: Assessing Best Practices to Characterize the Target Protein with Sufficiently Specific Assays


  • Benchmarking industry practices for characterizing target proteins
  • Uncovering the level of specificity of assays and the analytical tools used
  • Understanding how implementing analytics early in the process can predict insufficient quality or aberrant proteins

10:00 am Developing Analytics for Safety Packages for Regulatory Submission From Lab to Commercial Scale


  • Understanding what aspects of the ingredient and final formulation determine the safety for regulatory submission
  • Ensuring the validity of analytical frameworks from lab to commercial scale
  • Determining the number of replicates needed to reduce turnaround times

10:30 am Morning Networking Break

Considering Methods to Increase the Robustness & Efficiency of Analytics at Different Scales

11:30 am Integrating Online Analytics to Characterize Process Efficiency at Commercial Scale


  • Identifying critical analytics to indicate process efficiency such as temperature, dissolved oxygen, pH, biomass, turbidity, and viscosity
  • Exploring the viability of end-to-end online analytics
  • Ensuring the sensitivity of process analytics

12:00 pm Roundtable Discussion: Ensuring the Scalability of Analytical Frameworks to Streamline Tech Transfer


  • Promoting scalability of analytics through instrument selection
  • Highlighting critical bottlenecks in the scalability of measurements
  • Utilizing automation to drive efficiency and reduce error

12:30 pm Characterizing Strains’ Responses to Variable Process Parameters to Aid Strain Engineering at R&D Scale


Discussing high throughput techniques to characterize strains’ tolerance and target protein expression to different environmental conditions

Assessing the application of lab-scale data at commercial scale given that the parameters change

Exploring how effective analytics can reduce COGS

1:00 pm Networking Lunch

Utilizing Next-Generation Analytical Techniques & Processing Methods From R&D to Commercial Scale

2:00 pm Implementing Effective Data Storage & Processing Methods to Streamline Data Analysis


  • Reviewing principles to ensure effective organization and formatting of data to facilitate further analysis
  • Maximizing the standardization and automation of data to develop a consistent in-house framework to save time
  • Transitioning from in-house process modelling to more advanced models

2:30 pm Fireside Chat: Comparing Industry Approaches to Analytical Development to Accelerate Commercialization


Collaborating on current approaches and future plans to streamline analytical development to complement R&D

Sharing current industry pain points and critical improvement areas

Overcoming the vendor shortage to meet the market potential of alternative proteins

3:15 pm Chair’s Closing Remarks

3:30 pm End of Pre-Conference Analytical Development Focus Day