Achieving a sustainable biopharmaceutical industry will require adopting more environmentally friendly (cleaner, safer) processes and materials across product life cycles. This track features sessions that explore innovations across the value chain with the potential to significantly reduce the environmental footprints of biomanufacturing, distribution, and waste focusing on actionable insights and case studies such as:

• Technologies and strategies to realize efficiency gains in energy, water, and material use
• Solutions to transition toward circular economy models that design out waste and pollution while maintaining product quality, safety, and efficacy
• Advances in single-use & disposables technologies, process intensification, and process safety
• Cold chain optimization for minimal climate impacts

A strong quality system is well recognized as essential for the manufacturing of safe and effective therapies for patients. The effectiveness of this system is in part driven by Quality Culture. The prioritized quality focus, led by management, drives sustainable compliance and consistent manufacturing of high-quality drugs. Attributes of a strong quality culture include a proactive and vigilant approach that is science and risk-based, incorporating continuous improvement. If there is a strong quality culture, then a facility could likely be inspected less frequently and will incur less risk during the inspection. The FDA is in the process of establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments that will go beyond the CGMP requirements. The FDA believes this will support a more reliable drug supply chain, reducing quality failures, and fostering proactive continual improvement, and will have this assessed by a team of assessors using a standardized protocol. This session will explore the benefits of quality culture in pharmaceutical manufacturing. This can be discussed in the context of existing products on the market, as well as new therapies that could represent advancements over existing therapies.

Regulatory expectations for statistically underpinned Process Validation (PV) have become integral, notably in the FDA's life cycle approach (2011) and ICH Q12's Established Conditions (ECs). Challenges persist in biopharmaceutical tech transfer throughout the lifecycle (Stage 1-3) due to scale-down models, costly experiments, and complex unit operation interactions. Critical tasks like risk assessment, model qualification, control strategy setup, and Continued Process Verification (CPV) require statistical foundations for risk-informed decision-making.

Next-gen bioproducts, including biosimilars and Advanced Therapy Medicinal Products (ATMPs), amplify the need for efficient validation workflows, driven by data science.

This track will have interactive round table discussions proceeding the talks. Hence, we encourage participants to stay in the track to gain the interactive exchange on regulatory expectations, good practices, how to decrease instances of out-of-specification results, speed up time-to-market, and reduce manufacturing troubleshooting costs.

More and more innovative pharmaceutical products are coming onto the market. Be it in cell tissue and genetic technology or vaccines. In order to produce these new therapies, innovations in the manufacturing process are also required. Especially time to market and automation with robotics or innovative single-use systems to name just a few. This session will deal with Novel Technologies and how they meet the requirements of current regulatory requirements.

This track will focus on methodologies and case studies on how to accelerate commercialization, time-to-market, and progress through the product life-cycle for both Gen 1 and Gen 2 products. Case studies are sought from development, process characterization, tech transfer, validation, and product lifecycle management. Of special interest are We show novel approaches and use cases highlighting, for example:

• How process simulation, modeling, and self-learning systems can lead to less experimental efforts in process development and accelerate facility and operational readiness
• How to predict the success of tech transfer using holistic data management and data science tools
• How to provide a robust control strategy using end-to-end approaches and for integrated continuous biomanufacturing (ICB)
• How proactive lifecycle management planning can reduce development cycles and accelerate the introduction of the process into the commercial facility

In addition, we must make sure that the methods have their own life cycle: They need to evolve themselves along the life cycle of the product. Therefore, we will focus on solutions for the last steps of the data maturity model, hence self-adapting capabilities, real-time architectures along AI, and automated workflows.

Facility design is a pivotal aspect of biopharmaceutical manufacturing. Speed-to-market, cost pressure, global deployment, rapid drug development, increased manufacturing capacities, and change/uncertainty are all important factors biopharmaceutical companies need to consider. This synergy between science, drug product, process, and facility is held to the highest standard when patient safety is at stake.

Join us on a dynamic track as we explore the challenges and trends that are the driving factors behind Biopharmaceutical Facility Design. This track will cover facility planning considerations, the economic viability of a facility design that minimizes capital investment and operational costs while meeting production needs, and Regulatory Requirements surrounding Annex 1 EU GMP from a Contamination Control Strategy (CCS) and Quality Risk Management (QRM) perspective.