The 2024 ISPE Biotechnology Conference will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share insights, and provide an outlook on the evolving landscape and future of the development and manufacturing of biotechnology products.
This conference will focus on unique challenges associated with innovative pharmaceutical products applied and transferred to the (new) biosimilar, bio better, and follow-up biotechnology products, like cell and gene therapy, Advanced Therapeutic Medicinal Products (ATMPs), and mRNA-based product development and new applications. In addition, the conference will feature presentations with a focus on enablers for process development, speed-to-market, sustainability, product technology transfer, new concepts for control strategy, and manufacturing.
Throughout this event, we will discuss and consider key areas and advancements in biotechnology:
AI can potentially streamline various operational processes via enhanced automation. Explore the impact of automation and augmentation on innovative processes like ATMPs and gene therapy, redefining how we work.
There is more data to analyze than ever before. A top priority for companies includes finding ways to increase automation, data accessibility, and speed. Learn how to utilize data science in biopharmaceutical tech transfer and process characterization, and how to address challenges and regulatory expectations.
Delve into innovative strategies and technologies to increase sustainability and reduce the environmental impact of the biopharmaceutical industry.
Discover the added value of digitalized Quality Management in ensuring the effectiveness and compliance of quality systems, for reduced inspection risks, and support for a more reliable drug supply chain.
Uncover technological advancements in pharmaceutical manufacturing, including the expedited production of innovative therapies and the integration of robotics and single-use systems to meet current regulatory demands.
Dive into strategies for accelerating commercialization and time-to-market through the product life cycle. The conference will feature approaches aimed at reducing development cycles and enhancing the introduction of processes into facilities.
Explore the challenges, trends, and driving factors behind Biopharmaceutical Facility Design, such as facility planning considerations, economic viability, and regulatory requirements from a CCS and QRM perspective.
Expert Insights: Hear from industry leaders and regulators who will share their perspectives on the future of pharmaceuticals.
The 2024 Biotechnology Conference program committee is requesting proposals aligning with the following content areas:
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.
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 verification and validation, control strategy setup, and Continued Process Verification (CPV) require statistical foundations for risk-informed decision-making. In industrial practice, however, individual steps of the product life cycle and derived information and models do not connect seamlessly.
Next-gen bioproducts, including biosimilars and Advanced Therapy Medicinal Products (ATMPs) along with continuous manufacturing amplify the need for efficient validation workflows, driven by data science.
This track will feature interactive round table discussions following the presentations. Hence, we encourage participants to stay in the track to gain the interactive exchange on regulatory expectations, good practices, decrease instances of out-of-specification results, speed up time-to-market, and reduce manufacturing troubleshooting costs.
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:
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:
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.
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.
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Biopharmaceutical facility design is a critical aspect of the industry. Overall cost pressures in the global health system, regional requirements to deploy manufacturing rather than centralize manufacturing in one location, technology enhancements in cell biology and format, flexibility to accommodate multi-product campaigns with different production schedules, and speed-to-market are among...
The biotechnology industry continues to evolve, advancing the frontiers of science and engineering in the design, development, and manufacture of a wide variety of therapeutic modalities. Advances in cell and gene therapies continue to offer treatments for diseases that were previously uncurable, with seven approvals in 2023, including treatments for sickle-cell disease, hemophilia, type 1...
International Program Committee
