Smarter, Faster, Riskier? AI in Bioprocess Development

Workshop Chairs: Tobias Hahn (Cytiva), Christian Airiau (Sanofi), Jun Tian (Wuxi Biologics)

Artificial Intelligence (AI) is rapidly reshaping the way we work, promising unprecedented efficiency gains. But efficiency is never neutral. What trade-offs, risks, and opportunities come with the pursuit of optimization?

In this workshop, participants will explore both the promises and pitfalls of AI as an efficiency driver and uncover new opportunities for machine learning, AI, and large language models (LLMs).

Participants will work in groups to tackle provocative prompts designed to spark debate, challenge assumptions, and inspire actionable insights.

1. “If AI were in charge of our downstream process, it would eliminate ___ first.”

2. “If AI could fully automate one task tomorrow, it should be ___.”

3. “We hit our Key Performance Indicators (KPIs) thanks to AI, but now we’re worried about ___.”

4. “The algorithm said ‘no,’ but our gut said ‘yes’, we chose ___.”

The first topic will help us challenge the assumptions about what is considered “inefficient” and what a suite of AI agents would likely simplify. The second topic will help us assess our priorities, where should we start? What have some of us already tried and tested? We will then assess in topics 3 & 4 the impact of Modeling on our teams, in relation with Scientific depth, regulatory environment etc., as well as the role of expert knowledge working alongside with expert AI models.

From Bioreactor to Bottleneck: Solving High Titer’s Downstream Dilemma

Workshop Chairs: Ralf Kuriyel (Repligen), Kris Barnthouse (J&J), Chris Cowan (Regeneron)

As upstream productivity reaches new highs, downstream purification must evolve to match.  This session examines a high upstream productivity / high-demand scenario: bioreactor titers at 15 g/L and annual production targets of one (1) metric ton of antibody. Under these conditions, downstream operations encounter capacity constraints and intensification requirements, driving critical decisions in process design, facility adaptation, and technology selection. This late-stage, commercial-focused workshop will debate real-world case studies to evaluate strategies for achieving throughput, maintaining quality, and ensuring analytical comparability. 

Case studies to be discussed:

Retrofitting Under Existing Facility Constraints
How can existing manufacturing facilities adapt with limited time and budget to integrate new equipment and meet high-throughput demands?  What process constraints do you expect to encounter?  What technologies do you anticipate ruling in our ruling out

Designing for the Dream Facility
If time and budget were no object, how would you engineer a process or augment a facility to achieve optimal fit, productivity, and scalability?  What technologies would you look to incorporate?  What roadblocks to you anticipate?  For each roadblock provide at least one idea to address it!

Participants will consider quality and analytical comparability across these scenarios, while diving into broader opportunities such as Contract Development & Manufacturing Organization (CDMO) partnerships, process innovation, automation, capital asset strategy, and operational efficiency, and development time pressures.

Expect provocative questions, bias-challenging dialogue, and an interactive environment aimed at advancing solutions for one of the most pressing issues in modern bioprocessing.  Join us to rethink downstream purification for the high-titer era!”

Sustainability of Downstream Processing: From Theory and Practice

Workshop Chairs: Alois Jungbauer (BOKU), Judith Thoma (Boehringer Ingelheim), Mi Jin (Eli Lilly)

This workshop builds on the conclusions and recommendations from the Recovery Conference Series XIX and XX, aiming to explore how theoretical insights have been or can be translated into practical applications. The session will begin with the presentation of a case study demonstrating the use of digital tools for sustainability assessment and life cycle analysis. Building on this real-world example, participants will collaboratively identify key recommendations for integrating sustainability into early-stage development.

Discussion topics will include:

     How to incorporate the entire product life cycle into sustainability considerations during early development and whether a full life cycle analysis can be meaningfully streamlined.

     How digital tools and AI can accelerate the development of more sustainable processes, and what goals must be clearly defined to ensure such tools deliver actionable support.

     The vision of the sustainable facility of the future: how existing facilities can be made more flexible—both in scale and in multi-product capability—and what defines the cornerstones of a truly sustainable greenfield site.

     Assessing single-use versus stainless-steel technologies—what is genuinely more sustainable, what innovation and factors might change the equation, or should efforts rather focus on other levers for improving process sustainability.

     Identifying useful metrics for sustainability: what lessons can be drawn from BioPhorum and ACS Green Chemistry, and are we, as industry leaders, ready to converge on a shared position. Are there barriers to industry-wide adoption?

     Evaluating the social and economic impact of sustainable biomanufacturing: what potential conflicts might arise between sustainability and equitable access to life-saving medicines, and how can we prevent them.

By combining practical insights with collaborative dialogue, the workshop aims to articulate a shared vision for advancing sustainability in biomanufacturing and to provide actionable guidance for future industry initiatives.

Future-Ready Biomanufacturing: What, Where, and Why?

Workshop Chairs: Susan Fisher (Gilead), Krunal Mehta (Merck), XiaoXiang Zhu (Amgen)

Biomanufacturing is at a pivotal point — as modalities diversify and production paradigms shift, companies must make critical choices about what to build and where.  This interactive workshop brings together technical experts and strategic leaders to explore considerations around flexible facilities, process intensification, advanced control, and scale for AAV and other next-generation therapies to identify emerging best practices and decision frameworks for next-generation biomanufacturing infrastructure. 

We’ll tackle critical questions from four angles:

 

•     Facility Strategy: Should facilities prioritize flexibility or specialization? What factors drive the decision?

•     Technology Integration: When does intensified processing outperform traditional approaches? When does advanced process control offer benefits?

•     AAV and New Modalities: How do we reconcile large-scale demand with linear-scale production?

•    Business Strategy: Make vs buy? Scale up vs scale out? How to ensure resilience amid geopolitical shifts?

Join us to gain actionable insights that bridge science and strategy—helping you build a future-ready biomanufacturing ecosystem that is innovative, cost-effective, and globally resilient.

From Data Silos to Mature Digital Models

Worshop Chairs: Maurice Phelan (Sartorius), Moiz Diwan (Abbvie), Rajiv Devulapalli (Regeneron)

On the journey to a connected digital ecosystem, connecting a myriad of data sources is a fundamental step if we are to be successful in leveraging the power of new digital tools. This workshop will examine the opportunities and challenges on this journey and the critical and principal steps which this industry must get right to be successful.

Question to Consider for the Workshop:

1. With respect to data collection, what are the most significant or unique challenges presented by downstream recovery processes?

2. Are you currently using AI tools to accelerate preparation of downstream data for development reports and other submissions? Identify three key challenges?

3. Beyond the classical mAb and recombinant protein recovery processes, what are the most significant and unique data related challenges we face for newer and advanced modalities (conjugated biologics, cell & gene therapies)?

4. How far along the DPMM ( Digital Plant Maturity Model) are you for downstream recovery? What are the most pressing problems? How advanced is the taxonomy and ontology of your recovery data?

5.  With respect to data collection, what are the most significant or unique challenges presented by downstream recovery processes?

6.  Do you plan to use digital twins and advanced modelling tools? What are the special data systems requirements for these tools?

Engineered for Success: Skillsets of the Future in Downstream Bioprocessing

Workshop Chairs: John Balchunas (NIIMBL), Ranga Godavarti (Pfizer), Elizabeth Goodrich (Millipore)

As downstream bioprocessing evolves in complexity and precision, so too must the skillsets of the workforce driving this innovation. This session explores the intersection of technical mastery, digital fluency, and emotional intelligence in shaping the future of process development, MS&T, and manufacturing science. With a focus on downstream operations, we’ll examine how emerging technologies like AI, machine learning, and advanced analytics—as well as new product modalities and rapidly advancing technical careers—are reshaping roles.

We’ll also explore how academic institutions, industry leaders, public-private partnerships, and consortia can better collaborate to prepare and onboard the next generation of professionals. We’ll discuss how well we understand what is desired among BS, MS, and PhD-level graduates as well as identifying opportunities to standardize competencies and strengthen the pipeline.

Whether you're beginning your career or a mid-career scientist stepping into leadership, a hiring manager navigating talent gaps, or an educator shaping future curricula, this session will offer insights into building a workforce that is not only technically adept but also adaptable, collaborative, and equipped to drive tomorrow’s innovation.

Some discussion areas include:

   Technical & Digital Skills

   Soft Skills & Leadership

    Workforce Development & Ecosystem Readiness

   Training, Onboarding & Curricula