Workshops

Chairs: Mariona Bertran (Novo Nordisk), Karol Lacki (Repligen), David Roush (Roush Biopharma Panacea - RBP)

One may assume that with advances in scientific knowledge and a plethora of data for calibration that first principles will be employed in developing models for recovery of biological products. The goal of this roundtable is to foster a debate about the future state of modeling and the strategy on how to translate the opportunities into tangible and sustainable deliverables.

For example, if first principles are feasible for model development who and where will these be developed (Industrial CMC, Academia, Collaboration, Scale-up) and maintained over the lifecycle? https://onlinelibrary.wiley.com/doi/abs/10.1002/bit.27520. Standardization and reference state/system for model development?  How good is good enough? What are the acceptance criteria, and do they differ depending on context of use?  What is the role of ML and AI in model development? Mathematically consistent but physically relevant? Initial forays have revealed some limitations:https://www.npr.org/2023/02/02/1152481564/we-asked-the-new-ai-to-do-some-simple-rocket-science-it-crashed-and-burned

Chairs: Alexei Voloshin (3M), Mathew Westoby (Resilience), Hans Johansson (Purolite)

New therapeutic modalities, such as viral vectors, lipid nanoparticles, multi-specific assemblies, and others, present new opportunities to treat, cure, and prevent serious health conditions and greatly improve quality of life around the world. With these opportunities come process and manufacturing challenges that will dictate how fast these new treatments can be developed, tested, and commercialized. The new classes of therapeutics are larger, more complex, and have more complicated biochemistry compared to the current major classes of biotherapeutics such as mAbs. Let’s discuss the best ways to accelerate process development of these new modalities!

The round table will focus on three general areas to develop a set of recommendations for the wider conference audience.

Discussion area #1: Finding order in chaos – defining new modality spaces

·         How will the new modality space evolve?

·         How new is new?

Discussion area: Is legacy a valuable companion or excess baggage?

·         Scale-up vs scale-out?

·         To platform or not to platform?

·         Regulatory framework evolution vs revolution?

Discussion area #3: Let’s get down to business!

·         Are near and future bioprocessing priorities the same in these spaces?

·         Top 3 priorities and trends in bioprocessing strategy and technology for the future

·         Bottom 3 priorities and trends in bioprocessing strategy and technology for the future

Chairs: Alois Jungbauer (BOKU), Kris Barnthouse (J&J), Jean Aucamp (Lonza)

The main objectives of bioprocesses in biopharmaceutical manufacturing are to reliably deliver drugs in a relatively short time frame with high quality, and to avoid batch failures within a tight regulatory framework. Bioprocesses are highly complex, the level of automation is highly varying, and there is constant pressure to improve efficiency and reduce costs. In addition, climate change and resource scarcity require a reduction of the environmental footprint of bioprocesses and manufacturing facilities.

The global environmental impact of the entire healthcare industry has been almost completely unaddressed. The American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable has reported that the global warming potential for e.g. a US-based 2000 L process is approximately 22.7 tons CO₂eq per 1 kg drug substance. Process intensification and better plant utilization are key to reducing environmental impact. For a 2000 L single-use bioprocess, the estimated single-use systems account for 769 kg per batch compared to 226 kg for the chemicals used. Also, measures must be taken to prevent emissions from increasing further despite the growth of the sector.

In the biopharmaceutical industry, two extreme production scenarios are often employed: a fully disposable factory with the characteristics of small batch sizes, great flexibility, and speed, or a fixed large-scale plant with high capacity. Forward-looking solutions and ideas will be discussed on how to combine environmentally friendly practices and technologies with new bioprocesses for the benefit of the patient, supply security and profitability.

Three topics will be explored in this workshop, considering the current best practices used for established biologics production and ways to implement sustainable production that are compatible with high quality and reduced cost:

·         Metrics for assessing the environmental footprint of a bioprocess in context of societal impact of biopharmaceuticals

·         How to improve the environmental footprint through more sustainable process design and manufacturing practices and understanding the consequences for production costs

·         Implementation of a circular bioeconomy in bioprocessing with focus on contributions possible through downstream processing improvements (e.g., reduce, reuse, recycle)

• In the Race Against Pandemics, How Do We Innovate for Quicker Treatment and Vaccine Access?

Chairs: Sanchayita Ghose (BMS), Canping Jiang (Thermo Fisher Scientific), Chris Ladd (Moderna), Maurice Phelan (Sartorius)

We will engage in dynamic discussions aimed at drastically reducing the time to market for vaccines and drugs. This session is an urgent call to address the critical questions of pandemic preparedness in the context of CMC development and manufacturing. We will explore the technological advancements in recovery and purification, and standardization of platform technologies across various modalities such as proteins, mAbs, mRNA, and viral vectors and delve into the accelerated CMC pathways that have emerged from the crucible of COVID-19, analyzing innovative regulatory and quality approaches. Operations will take center stage as we discuss the optimization of supply chains, the urgency of rapid capacity deployment and the potential of decentralized manufacturing. The three breakout sessions will focus on:

1.      Technology Advancement & Platform Standardization: Discover cutting-edge advancements in recovery and purification, and the push for platform standardization that's revolutionizing vaccine and drug modalities from proteins to mRNA and beyond.

2.      Accelerated CMC Development: Examine the fast-tracked pathways of CMC development, and discuss the innovative regulatory frameworks (e.g. platform technology designation) and quality approaches enabling this rapid progress.

3.      Operational Excellence in Supply Chain and Manufacturing: Explore strategies for optimizing supply chains (in both raw material sourcing and product distribution), rapidly deploying manufacturing capacity, decentralizing production, and managing the workforce to meet the demands of a health crisis.

We will discuss the following questions in each break out session:

•      What are the new technologies, new ways of working developed in our industry that are significantly impactful overcoming the critical challenges imposed by the COVID-19 pandemic?

•      What challenges and gaps still exist? What actions can we take today to close the gaps. What can we do across industry, countries, governments, companies and academia?

•      What key processes, systems, and ways of collaboration should we build or improve today to sustain the agility demonstrated in responding to the COVID pandemic?

Chairs: Jorg Thommes (JT Consulting), Lisa Connell-Crowley (Just – Evotec Biologics), Suzanne Farid (UCL)

Join us for an engaging workshop session focused on the pressing issue of bringing down biopharma manufacturing costs and ensuring wider access to advanced biotherapeutics in low and middle-income populations. In this workshop we will explore innovative strategies, insights, and potential solutions to make advanced biotherapeutics more affordable and accessible; this will cover modalities ranging from mAbs through to viral vectors, nucleic-acid therapies and beyond. We will delve into cost-effective manufacturing techniques, draw inspiration from lower margin industries, and examine the possibilities of newer modalities in driving costs down. Additionally, we will explore the potential of distributed manufacturing as a means to improve equitable access to advanced medicines for underserved populations. Don't miss this opportunity to be part of the conversation shaping the future of global healthcare access.

We will be tapping into your experiences and insights on these two core themes, addressing questions such as:

Theme 1: Innovative Approaches to Cost-Effective Manufacturing

1. While the cost of manufacturing is only a very minor contributor to the cost of drugs in high-income countries, it will be limiting profitability in low and middle-income countries. What are the main levers to reduce the cost of manufacturing that can enable access to underserved populations?
2. What valuable insights can we gain from lower margin industries like the food industry or industrial enzyme production about cost-efficient biopharmaceutical manufacturing?
3. How can the vaccine industry's experiences with high volume/lower cost manufacturing inform strategies for expanding access to advanced biologics in resource-constrained settings?

Theme 2: Striking the Balance: Cost Efficiency for Wider Access

4. With the emergence of mRNA-based therapies, do we anticipate lower production costs compared to traditional protein therapeutics, and if so, how can we leverage this potential for wider accessibility?
5. Is distributed manufacturing a viable solution to improve equitable access to advanced medicines in underserved populations, and what are the challenges and opportunities associated with this approach?
6. How can we foster collaboration among stakeholders to ensure wider access to advanced biotherapeutics?

Our goal is to facilitate a lively and interactive discussion where we encourage open dialogue and sharing of experiences from all participants. We will start with a quick check-in with participants for additional suggestions and prioritization of topics for the group to tackle. Please feel free to forward comments to us before the meeting.