The sessions will be chaired by recognized industry experts with broad experience and insight in their respective disciplines. A key part of the meeting is to deliver an overview of strategic issues, patient perspectives or highlight developing market trends compiled from submitted presentations. The following areas.will be covered:
Session 1. Advancing plasma therapeutics from early research to clinical trials
Chair: Sami Chtourou, K2C-BIOPHARM
Human plasma products market is currently doing well with an expected average growth rate of
6 to 8 % per year for the next five years. Currently, global demand sometimes exceeds the supply offered by this industry. However, to continue ensuring the economic balance of this industry, new production technologies, new diagnostic tests, new products and new clinical indications for existing products are actively sought by plasma fractionators and their academic partners. The objective for this session entitled Advancing plasma therapeutics from early research to clinical trials is to highlight the main achievements in these fields Communications are expected to cover technological innovations in the fields of proteomics and associated technologies useful for the identification of new proteins of potential therapeutic interest, new diagnostic tests allowing better patient management and rationalization of the use of products. Presentations of clinical trial results aiming at validating either efficacy and safety of new plasma derived proteins or extensions of indications for existing products will also be welcomed.
Session 2. Novel technologies and solutions for plasma fractionation
Chair: Merche Faro, Grifols
Source and recovered plasma is the starting material used to manufacture lifesaving therapies. The current plasma fractionation methods used by the pharmaceutical industry still derive from the cold ethanol precipitation process developed in the 1940’s by Cohn, however new technologies have evolved dramatically in the last few decades towards new fractionation approaches and the transition has already begun. The main goal of this session is to highlight and discuss the new emerging trends and strategies in plasma fractionation beyond the classical methods. Communications are expected to cover technological innovations in the field of non-chromatographic methods including protein precipitation techniques, liquid:liquid extraction high performance tangential flow filtration, ultrafiltration utilizing charged membranes and lipid or lipoproteins removal solutions to prepare a clarified intermediate ready to be processed by next generation chromatographic methods such as size exclusion, ion exchange, hydrophobic interaction or bioaffinity chromatography to achieve higher quality and yield. Final product safety will also be a key topic to be discussed as an evolving trend.
Session 3. Plasma 4.0 – digital transformation of the plasma business and manufacturing
Chair: Barbara Kalina, CSL Behring
This session will explore how plasma fractionators are transforming their manufacturing operations. With the industry already experiencing constraints in supply of IVIg despite a rapid increase in fractionation capacity, process yields and efficiency for the industry has never been more important. As most fractionation processes are based on the well-established cold-ethanol methods, fractionators have driven efficiency by efforts to remove process bottlenecks. Further gains in efficiency are now being realised by technological advances, which have been enabled by digital transformations. These advances enable collection and use of key process information in real time to drive improved process control and hence product quality. The transformation has also permitted plasma fractionators to use this information to drive an end-to-end concept to manufacturing and supply of these critical therapies. This session will also explore how the plasma industry can further harness advances in artificial intelligence, machines learning, digitisation and learnings from the broader biotechnology industry to further drive efficiency gains and ensure consistent supply of products to patients.
Session 4. Safety, Quality and Regulatory aspects of plasma fractionation
Chair: Beatrice Biebuyck, Takeda
This session will explore recent regulatory and quality developments in the field of plasma and how plasma supply challenges exacerbated by the COVID-19 pandemic further highlight the need for regulatory policy changes in how source plasma is regulated. We will hear from leading experts in the field of pathogen safety and NAT testing. We will also hear from regulatory and quality experts on advances in downstream processing and virus inactivation and removal methodologies during the manufacturing processes of plasma products. We will tie these scientific, safety and quality underpinnings of plasma sourcing and manufacturing back to regulatory policy and discuss with key industry, regulatory and health policy experts, the relevance of certain regulatory requirements imposed on plasma manufacturers, including donor deferral criteria. We will explore the impact these regionally disparate regulations have on limiting access to source plasma needed in the manufacture of important lifesaving therapies for patients. This integrated discussion will include podium presentations by, and a roundtable discussion with, leading virologists, scientists, regulators, and industry representatives in the field of plasma fractionation.
Session 5. Future perspectives on the plasma business and market
Chair: Eric Youssef, Cytiva
This forward looking session will address global trends in the plasma product market including the emerging competition to plasma products from gene therapy and engineered antibody alternatives. Following consolidation of the industry, major fractionators have reported healthy revenues and returns and we therefore ask how the industry will be able to maintain this development. Will new entrants challenge the oligopoly? How will the disparate availability and usage of plasma products over different regions evolve and what effect will it have on the sourcing of plasma, location of production and distribution develop? With immunoglobulins driving the plasma product market the inability of some countries to provide enough plasma to meet IgG demand raises questions of self-sufficiency and the ability to treat patients in need. The US dominance of the plasma supply adds to the issue of supply chain risk as well as the future cost of plasma products.