The 2023 PDA BioManufacturing Conference Lands in Seville, Spain

With the evolution of worldwide demographics and the recent pandemic, interest in pharmaceutical biomanufacturing activities has increased, and the bioindustry has been under more scrutiny from different stakeholders, ranking from investors to regulators, considering the public health and environmental impact. Therefore, it is extremely important to take the opportunity to stay informed about the latest development in this field. The 2023 PDA Biomanufacturing Conference is the perfect place to go and, this year, it is dedicated to the theme Agility and Biomanufacturing Excellence to Meet Patients' Needs.

The scientific committee has built a compelling program for the conference’s fifth anniversary, including topics from the former PDA Lyophilization Conference since its successful integration in 2022. The 2023 agenda offers a full experience that involves emerging trends in biomanufacturing and regulatory focus areas. We will meet face-to-face as a two-track conference in Seville, Spain, on September 12-13, 2023.

Beyond the COVID-19 health emergency, this year’s program focuses on revealing and exploring new technologies, development approaches, chemistry, manufacturing and control (CMC) strategies, and regulatory frameworks to support rapid access to vaccines and biotherapeutics for all manufacturing and control strategy aspects. This includes upstream to final filling and lyophilization steps such as sustainable lifecycle management. The 2023 PDA Biomanufacturing Conference offers a key opportunity to network with many industry stakeholders, including representatives from such regulatory agencies as the European Medicines Agency, U.S. Food and Drug Association and other country-specific health agencies, as well as academia. Moreover, attendees will have a chance to network with global health-driven organizations like the Coalition for Epidemic Preparedness Innovations (CEPI).

Regulatory Framework

In order to bring innovation to patients, it is of fundamental importance for the industry to:

• Ensure timely and continued connection with regulatory agencies
• Establish common knowledge grounds on manufacturing trends
• Verify opportunities in the technical and regulatory framework

Over the last five years, the PDA BioManufacturing Conference has contributed to this critical dialogue, bringing together experts from several modalities in the biomanufacturing space with an opportunity to present work, participate in panel discussions and network during the event. For the 2023 edition, the first plenary session will provide extensive reflection on the regulatory framework for innovations in CMC for biotherapeutics and vaccines. This will showcase opportunities and examples of collaboration between the industry and regulatory agencies that assist in driving the implementation of new technologies and digital strategies in the biopharmaceutical area. Furthermore, CEPI will provide perspectives on accelerated CMC development roadmaps that reflect the interdependency between innovation and rapid access to patients, especially in cases of epidemic or pandemic scenarios. This, along with the presentations from members of the industry and academic institutions during the conference, will set the basis for the closing plenary session that will focus on health emergency preparedness for the future. In that session, we will explore the progress of implementing pandemic-related learnings from the industry and regulators, including concrete initiatives from CEPI and new guidance tools from health authorities.

In addition to the regulatory framework, the 2023 PDA BioManufacturing Conference will offer evidence-based case studies and experts’ views on biopharmaceutical development, advanced modeling approaches, biomanufacturing capacity, sustainability, and digitalization and artificial-intelligence opportunities for both vaccines and biotherapeutics.

Innovative Technologies

Our biomanufacturing landscape is highly evolutive, and recent years have seen an increase in such innovative technologies as digitalization and artificial intelligence (AI), including, but not limited to process and product modeling. These new technologies play a key role in biomanufacturing with concepts like Industry 4.0 and digital twins, which industry experts will discuss, emphasizing the use of AI in our industry. In particular, we will hear how AI can support biotechnology processes to improve their robustness by being more predictive or ensuring more efficient training via machine-learning methods. The subject of modeling will be presented through different angles concerning lyophilization while also showing the efficiency of tools like quality by design, predictive models and simulation, which contributes to better process characterization. At the 2023 Biomanufacturing Conference, experts will describe modeling tools for biotherapeutics and vaccines with the final goal of manufacturing drugs safely within a limited time and with limited resources.

Sustainability

Sustainability has become more of a major concern all over the world, which greatly affects the pharmaceutical industry. Furthermore, the regulatory framework is evolving quickly, and mid- to large-size industries are concerned with including sustainability in their annual reporting. At the 2023 PDA BioManufacturing Conference, we will explore how to meet environmental and climate targets in drug innovation, product design, manufacturing and drug distribution. Using case studies in process intensification, our experts will explore how new manufacturing technologies can support sustainability goals. For instance, process intensification can provide a holistic framework for improving the overall efficiency of production with greater volumetric productivity while reducing waste and energy consumption and contributing to improved sustainability.

Vaccine Interest Group Session

As in previous years, the conference will host a session with two presentations in collaboration with the PDA Vaccine Interest Group this year. The first presentation will be dedicated to the recently published PDA Technical Report No. 89: Strategies for Vaccine Development, focusing on vaccine development and lifecycle management. The team lead of the authoring task force will share insights on the topics discussed in the document, and participants will have the opportunity to engage and ask questions during an interactive panel discussion. The second presentation will focus on strategies for setting vaccine specifications, a challenging topic, and one particularly relevant in accelerated scenarios and in consideration of the planned revision of ICH Quality Guidelines Q6A/B on specifications for test procedures and acceptance criteria.

 

The first presentation will be dedicated to the recently published PDA Technical Report No. 89: Strategies for Vaccine Development, focusing on vaccine development and lifecycle management. The team lead of the authoring task force will share insights on the topics discussed in the document, and participants will have the opportunity to engage and ask questions during an interactive panel discussion. The second presentation will focus on strategies for setting vaccine specifications, a challenging topic, and one particularly relevant in accelerated scenarios and in consideration of the planned revision of ICH Quality Guidelines Q6A/B on specifications for test procedures and acceptance criteria.

We are proud to celebrate the fifth anniversary of our PDA BioManufacturing Conference and to continue bringing the opportunity to present new technical and regulatory developments in the field. We are pleased to have experts from regulatory agencies, industry and academia available to discuss these developments in exciting oral presentations and poster sessions. We expect this meeting to offer you an excellent opportunity to gain greater knowledge in biomanufacturing, reflect on future possibilities and expand your network.

We look forward to seeing you at this exciting and interactive 2023 PDA Biomanufacturing Conference!