Pre-Conference Workshops
Tuesday, October 18, 2022

WORKSHOP A

09:00 - 11:00

Innovating Analytical Methods to Ensure Product Quality and Efficacy

• Balancing design of experiments with testing capabilty to create lean and efficient analytical processes

• Streamlining analytical testing to remove quality control and testing as a bottleneck in the product cycle

• Transitioning towards automation in analytical development to increase speed, reduce labor and bring down the cost of processes

• Aligning process development, assay development, and analytical studies behind the target product profile to design analytical processes which are valid and tailored for the product

• Operationalizing potency assays to characterize potency quickly and at scale, through minimally complex assays to correlate potency and product quality

Workshop Leaders:

marty giedlin

Marty Giedlin
VP, Head of Technical Operations
Senti Bio

Panos Chrysanthopoulos

Panos Chrysanthopoulos
Senior Director, Process & Analytical Development
Artisan Biotechnologies

WORKSHOP B

11:30 - 13:30

Implementing Automation to Streamline and Scale Up Processes Whilst Balancing Complexity and Product Quality

• Discussing advances and unmet needs in automation, from manufacturing to quality systems and analytical sciences

• Debating the extent of automation, end-to end or units, considering processes which require manual oversight, and highlighting the ‘low-hanging fruit’ to begin to close and automate processes

• Carrying out process changes through phases to transition to streamlined, scalable, automated platforms

• Bringing automation in-house vs. outsourcing to vendor technologies

• Prioritizing the challenges which automation can address, when to deploy, and what are the common goals in process development that automation can help achieve

Workshop Leaders:

danielle hayes

Danielle Hayes
Associate Director, Bioprocess Engineering
Triumvira Immunologics

nathan moore

Nathan Moore
Associate Director, Engineering & Automation
Takeda

WORKSHOP C

14:30 - 16:30

Optimizing Cryopreservation and Fill & Finish to Monitor and Maintain Cell Quality Whilst Avoiding Contamination

• Creating cryopreservation protocols which are scalable and comparable without compromising quality

• Integrating process analytical technologies to continuously monitor quality from manufacturing through to infusion

• Leveraging automated fill & finish technologies to reduce contamination, labour intensity, cost and time of production

• Moving towards parallel batch production and planning to scale downstream processes, minimizing turnaround time and cost

Workshop Leaders:

mark lalli

Mark Lalli
Associate Director, Process Development
Be Biopharma