PDA BioManufacturing Conference 2024 Lands in Gothenburg, Sweden

The bioindustry has been continuously innovative in proposing new solutions to those threats and successfully developing its manufacturing capabilities. Accordingly, this industry is now under more scrutiny from different stakeholders, from investors to regulators, considering the public health and environmental impact. Therefore, it is important to take the opportunity to stay informed about the latest developments in this field. The PDA BioManufacturing Conference 2024 is the perfect place to go, and this year, it is dedicated to the theme of Shaping the Future of Biomanufacturing.

For this sixth year of the conference, the scientific committee built upon the experience of the previous conferences and provided a compelling program, including the previous PDA Lyophilization Conference, after successful integration in 2022. The 2024 agenda offers the full experience, covering emerging trends in biomanufacturing and regulatory focus areas. A special focus has been given to freeze-drying and fill and finish technologies in addition to the usual focus areas like vaccines, monoclonal antibodies and innovative manufacturing technologies. We will come together as a two-track conference face-to-face in Gothenburg, Sweden, on 24-25 September 2024.

Our program this year is focused on revealing and exploring new technologies, development approaches, chemistry, manufacturing and control strategies (CMC), and regulatory frameworks that will shape the biomanufacturing environment in the years to come. In addition, we will discuss rapid access to vaccines and biotherapeutics for all manufacturing and control strategy aspects, from upstream to final filling and lyophilization steps, including sustainable lifecycle management. There is a key opportunity to network and exchange with many stakeholders from the industry, academics and regulatory agencies like the Swedish Medicine Agency, the European Federation of Pharmaceutical Industries and Associations, and the Paul Ehrlich Institute. Individuals will also be able to network with global health-driven organizations like the Coalition for Epidemic Preparedness Innovations and Vaccines Europe.

Regulatory Framework

The regulatory framework in the pharmaceutical industry aims to ensure safe and efficacious medicines for patients. This year’s PDA BioManufacturing Conference 2024 will focus on serving the patient’s needs accordingly, starting with the patient’s voice. We will continue this patient-centric view on vaccine development and share the experience with patient-centric specifications. New aspects of ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances will be presented from a regulator’s point of view as well as from the industry side.

It is important for the industry to ensure a timely and continued connection with regulatory agencies, set common knowledge grounds on manufacturing trends and verify opportunities in the technical and regulatory framework. The PDA BioManufacturing Conference 2024 contributes to this critical dialogue, bringing together experts from several areas in the biomanufacturing space with an opportunity to present work, actively participate in panel discussions and network during the event. This year’s second plenary talk will set the tone for shaping the future in biomanufacturing on modern treatment modalities that create new treatment options for patients. Innovation in CMC and fill and finish will be discussed in terms of technical-scientific aspects, modeling, simulation and digitalization examples, as well as a regulatory framework to enable these future-shaping technologies. In our globalized world, the industry seeks to harmonize such regulatory frameworks. Our speakers will provide insight into the experience of multi-region submissions, and we will then discuss innovative regulatory strategies for a globalized world in our second plenary discussion.

Innovative Technologies

Biomanufacturing provides innovative technologies each year. This year, the conference will focus on freeze drying, vaccines and other therapy innovations, namely with several sessions on digitalization, artificial intelligence and patient-centric methods, including, but not limited to process and product modeling. Our experts will discuss the regulatory framework enabling digital innovation in manufacturing and using digital twins for accelerated process development.

Sustainability

This topic is mandatory for the bioindustry and has evolved tremendously recently. This session aims to provide updates on the regulatory framework applied to our industry. We will explore how sustainability topics are implemented in our industry with an overview of environment, social and governance scores, especially with this year's new regulatory framework for sustainability reporting. We will also discuss how to recycle, reuse, reduce and repurpose water for pharmaceutical use.

Join the Interest Group Sessions

For this conference, we have enlarged the PDA Interest Group's (IG) participation, and we are pleased to host two interest groups: Lyophilization IG and Advanced Manufacturing, and Applied Process Digitalization IG (former Biomanufacturing IG). This year, those sessions will have the opportunity to provide the latest advancements in their common work and display the benefits of participating in IGs facing the future of biomanufacturing. The vaccine IG will also manage a special session to explore the opportunities to accelerate vaccine access. In addition, Vaccines Europe will provide us with the latest advancements in the regulatory framework and how to efficiently answer the requirements with a special focus on patient-centric methodologies and tailored specifications.

We are proud to continue to provide useful information and great networking during our PDA BioManufacturing Conference 2024. The conference will bring the opportunity to discuss new technical and regulatory developments in the field. We are pleased to have experts from regulatory agencies, industry and academia to discuss these developments, with exciting oral presentations and poster sessions. This meeting offers an excellent opportunity to gain experience in biomanufacturing, reflect on opportunities and expand our network. We look forward to seeing you at this exciting and interactive meeting!