RXIX Conference Theme — Past, Present, Future

Downstream processing plays a crucial role in the production of various biotherapeutic modalities. Advances in downstream processing have mirrored the trajectory of drug development pipelines, which have shifted from a dominance of hormones, cytokines and blood factors to monoclonal antibodies to more novel engineered antibody formats. More recently, notable successes in cell and gene therapies and other nucleic acid-based products have triggered a resurgence in interest in these modalities as potential game changers. Furthermore, a number of biologics, such as ADCs, polypeptides, and mRNA-based products, require integration and optimization of chemical/enzymatic synthesis with bioprocess steps. As a result, the sector is dealing with much more diverse pipelines that pose a range of distinct purification challenges.

The desire for more flexible and agile facilities is driving innovative facility design concepts that rely on process intensification, single-use technologies, additive technologies, PAT and more integrated processes. Furthermore, increases in more personalized therapies as well as on-demand production will require more automated, flexible and potentially portable manufacturing platforms that can make-to-order cost-effectively. Regional or bedside production may require novel GMP-in-a-box units or miniature/micro- facilities with integrated and single-use units combined with paradigms such as cell-free synthesis or continuous processing. The trend towards more targeted therapies will require also novel approaches to quality control and product release methods, regulatory pathways, reimbursement models, supply chains and ultimately business models.

Advances in digital technologies such as online sensors, automation, robotics, big data analytics, mechanistic models and AI have the potential to transform process understanding, enable facilities to become connected digital networks and accelerate industrialization of the sector. This will enable companies to leverage data for decision-making at an enterprise level rather than the traditional siloed approach. Pressure to find digitalization solutions may be even more pressing with personalized cell and gene therapies where the quality infrastructure could become a bottleneck and where track-and-trace capabilities are critical to assure chain-of-custody.

Future modalities can learn from the trajectories of the present and past, whilst also paving the way to embrace new technologies that are more urgent for their success. In this conference, we will aim to highlight past achievements that are part of our foundation, focus on cutting-edge solutions for present challenges and look to build a roadmap together to enable the future. The RXIX conference will bring together leading scientists and engineers from industry, academia and regulatory authorities that are actively engaged in the purification of diverse biotherapeutic modalities.

The agenda will include progress on the state-of-the-art technologies and emerging trends in downstream unit operations for diverse biotherapeutic modalities (e.g. proteins, peptides, cell and gene therapies including viral vectors and nucleic acid-based products ), a range of expression systems, universal and personalized therapies, and different facility design concepts (batch, continuous, single-use, micro-facilities). Case studies will be presented on harnessing digital technologies for manufacturability prediction, root cause analysis and adaptive control.

We look forward to welcoming you to Rome, Italy, to share past, present and future perspectives on the recovery of biological products.