Integrated and continuous biomanufacturing is being implemented across the biopharmaceutical industry. It is a powerful process intensification tool enabling cost-effective, lean, and agile manufacturing facilities.Importance of cognitive learning theory the development of these technologies has been discussed in our past conferences ICB I (2013), ICB II (2015), and ICB III (2017).

ICB IV will bring together leading scientists and engineers from academia, industry, and regulatory agencies who are actively engaged in the field of integrated continuous biomanufacturing.Importance of cognitive learning theory we look forward to welcoming you to brewster (cape cod), massachusetts, USA in october 2019 for a scientific exchange in pursuit of advancing the adoption of ICB and serving patients’ needs.Importance of cognitive learning theory

As continuous manufacturing in the biopharmaceutical industry gains momentum, approaches towards the integration of enabling technologies and implementation in a GMP environment are evolving.Importance of cognitive learning theory this session aims to highlight the successes and challenges of innovative approaches towards GMP manufacturing in the modern era. These could include case studies on the approaches to process validation for continuous biomanufacturing, environmental classification, integrated digital strategy, advanced process control and monitoring as well as analyses of cyclic data generated during continuous operations.Importance of cognitive learning theory we also invite talks focused on design criteria for GMP manufacturing, reduction of operational complexity, handling of perturbations in continuous operations and quality considerations while transferring processes to a GMP environment.Importance of cognitive learning theory finally, contributions focused on the challenges with scalability and robustness of enabling technologies—process intensification technologies, PAT and single use systems are encouraged.Importance of cognitive learning theory

This session addresses the question what smart ICB development looks like. Therefore, we are inviting contributions that illustrate the impact of continuous bioprocessing on development timelines.Importance of cognitive learning theory we invite approaches to meet requirements for both productivity in manufacturing and speed to clinic in development. This can, for example, include high-throughput approaches and process modeling for ICB, small scale models, new doe concepts for ICB process optimization and characterization, integrated process control concepts, insights where batch methods can be leveraged for ICB development as well as regulatory considerations.Importance of cognitive learning theory

This session will focus on digitalization, process analytical technology (PAT), and artificial intelligence concepts for integrated continuous biomanufacturing (ICB) including, but not limited to, tools for accelerating and making more robust process control and transfer, emerging and enabling analytics technologies, as well as overall strategic technological considerations.Importance of cognitive learning theory

In this session, we ask to elaborate on the approach and associated challenges toward a comprehensive ICB validation strategy (or conceptual framework) and to provide convincing data from case studies that support that strategy.Importance of cognitive learning theory validating an ICB process poses additional challenges compared to batch processing due to its integrated and intensified nature (e.G. New set of process parameters and their ranges).Importance of cognitive learning theory we will consider examples featuring

The biopharmaceutical sector is experiencing a shift from evaluating the potential of integrated continuous operations to implementing them at scale in clinical and post-approval stages.Importance of cognitive learning theory concepts for integrating continuous operations are also evolving with end-to-end designs that are fully continuous through to those that combine continuous and connected or straight-through processing steps.Importance of cognitive learning theory yet challenges may still exist for routine implementation to close any gaps on several fronts such as the need for new ICB technologies, analytics, monitoring and control algorithms as well as the need for a sustainable business case.Importance of cognitive learning theory

We invite talks that present case studies on the implementation of integrated continuous platforms with details of the consequences on the process development and CMC strategy, the time-to-clinic and time-to market, the facility design and scheduling, the process economics and of any efforts to overcome hurdles.Importance of cognitive learning theory case studies can focus on the integration of two or more continuous operations, end-to-end fully continuous demonstrations, bench-scale and/or large-scale implementation.Importance of cognitive learning theory visions for rollout of these continuous platforms for regional supply of therapies and multiproduct facilities are also encouraged.

This session would welcome both upstream as well as downstream continuous processes or unit operations for newer types of complex biopharmaceuticals, in particular for vaccines, gene or cell therapy, delivery of RNA or proteins, amongst others.Importance of cognitive learning theory use of different biologies, including pichia pastoris or escherichia coli, apart from animal cells or non-cell, dependent purification or delivery bioprocesses are equally welcome.Importance of cognitive learning theory

Massimo morbidelli has had an outstanding professional and scientific career spanning more that 33 years. His research has addressed key scientific issues in a remarkably broad range of distinct areas including reaction engineering; catalyst design; polymer chemistry and engineering; materials characterization and synthesis; colloids and surface science; modeling of physiochemical interactions in separations; development, modeling and design of separation processes; process control; and, more recently, cell culture and continuous processing for biopharmaceutical manufacturing.Importance of cognitive learning theory with 5 co-authored books, well over 650 publications, and 20 patents, massimo is a recognized international expert and a thought leader in many areas.Importance of cognitive learning theory he has graduated over 100 phd students, many of whom have gone on to achieve professional excellence in many areas. Beyond academia, massimo has been intensely involved in directing and starting up new industrial ventures, including chromacon AG, which is focused on continuous chromatography for protein purification, and datahow AG, which is focused on big data analysis in bioprocessing and other industries.Importance of cognitive learning theory

Massimo has made enormous contributions to integrated and continuous biomanufacturing, which have been instrumental to the scientific and practical progress of this area during the last decade.Importance of cognitive learning theory he is responsible for the invention and development of the multi column solvent gradient process (MCSGP) process, which applies the concept of simulated continuous countercurrent operation to purification processes in the bio-pharmaceutical industry.Importance of cognitive learning theory this process has been applied to a growing list of different purifications including capture and purification of monoclonal antibodies from cell culture supernatants, purification of bispecific antibodies and antibody charge isoforms, recovery of pure peptides (calcitonin) from crude mixtures, the production of omega-3 fatty acid ethyl ester (EPA-EE), the extraction of alpha-1-antitrypsin from human plasma, and the separation of mono-pegylated from unpegylated and multi-pegylated proteins.Importance of cognitive learning theory beyond continuous downstream processing, massimo has also been responsible for the conception and development of innovative processes that couple continuous upstream and downstream steps for truly integrated and continuous bio-manufacturing.Importance of cognitive learning theory while continuous chromatography offers, on its own merits, tremendous advantages in terms of productivity and capacity utilization, even greater advantages are obtained when continuous chromatography is coupled with continuous upstream production.Importance of cognitive learning theory massimo’s work has made it possible to achieve on a practical scale the end-to-end continuous integrated manufacturing of therapeutic proteins by integrating a perfusion bioreactor with continuous chromatographic capture chromatographic, followed by continuous viral inactivation, and by a MCSGP system for polishing.Importance of cognitive learning theory such an end-to-end continuous flow integration, without holding tanks and with controlled operation is indeed the goal of ICB. Massimo’s contributions have been instrumental in making this possible.Importance of cognitive learning theory

Massimo has recently co-authored (with 2 of his former phd students) the book: D. Pfister, L. Nicoud and M. Morbidelli, continuous biopharmaceutical processes2018, new york, USA: cambridge university press.Importance of cognitive learning theory this book brings ICB in sharp focus providing the tools to understand, model, and implement continuous bioprocessing. He keeps contributing to integrated continuous biomanufacturing through his research, industrial activities, and the education of scientists and engineers in this field.Importance of cognitive learning theory major sponsors

Native population cape cod has been the home of the wampanoag native american people for many centuries. They survived off the sea and were accomplished farmers.Importance of cognitive learning theory they understood the principles of sustainable forest management, and were known to light controlled fires to keep the underbrush in check. They helped the pilgrims, who arrived in the fall of 1620, survive at their new plymouth colony.Importance of cognitive learning theory cape cod was among the first places settled by the english in north america. Transportation

The format of the conference provides morning and late afternoon or evening sessions in which major presentations are made.Importance of cognitive learning theory poster sessions will be scheduled for evening discussion as well. Available time is included during the afternoons for ad hoc meetings, informal discussions, and/or recreation.Importance of cognitive learning theory this format is designed to enhance rapport among participants and promote dialogue on the development of the meeting. We believe the conferences have been instrumental in generating ideas and disseminating information to a greater extent than is possible through more conventional forums.Importance of cognitive learning theory