Integrated Continuous Biomanufacturing III

An ECI Conference Series

September 17-21, 2017
Hotel Cascais Miragem
Cascais, Portugal

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ICB Award Winner: Konstantin Konstantinov

Session Descriptions                      Conference Brochure

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About this Conference

Continuous bioprocessing has the inherent advantage of higher productivity which can facilitate implementation of small process trains, resulting in cost-effective, lean, and agile manufacturing facilities.  Impressive technological advances to enable continuous bioprocessing have been made in the recent past and have been discussed at Integrated Continuous Biomanufacturing (ICB) I (2013) and II (2015) conferences.  The range of topics that were discussed illustrates the active and enthusiastic engagement of biopharmaceutical industry, academia, and regulatory authorities.

ICB III (2017) aims to build on the strong momentum generated at the previous two conferences in the series.  The agenda will include progress on the state-of-the-art technologies and emerging trends in continuous upstream, downstream, and drug product unit operations.  Case studies for the implementation of continuous platforms will also be discussed, spanning scale-down mimics and control strategies through to end-to-end continuous processes and facility designs.

The ICB conference will bring together leading scientists and engineers from academic, industry and regulatory authorities who are actively engaged in integrated continuous bioprocessing.  We look forward to welcoming you to Albufeira, Portugal, and debating how industrialized our sector can become and the scenarios where continuous platforms will better serve our needs.

Conference Organization

Co-Chairs:

Suzanne Farid, University College London, UK
Chetan Goudar, Amgen, USA
Paula Alves, IBET, Portugal
Veena Warikoo, Axcella Health, Inc., USA

Abstract Submission

Detailed session descriptions are available as a link on the website.  Please use these descriptions to pre-select a session where you believe your work fits best.

Abstracts (one page maximum) that include specific results and conclusions to allow a scientific assessment of proposed oral presentation or poster are invited.  Abstracts must be submitted electronically using the template provided at This Link.

Note that most oral presentations are invited; however, there are still a number of slots open. Abstracts not selected for one of the limited oral presentation slots will be considered for a poster presentation.

Oral abstract submission deadline: April 10, 2017

Poster abstract submission deadline: April 24, 2017

Abstracts of all presentations will be published in the conference program, available to all participants at the time of the conference.

Major Sponsors

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Oral Session Descriptions

Session 1: Continuous Culture to Capture

Chairs:  Martina Micheletti, University College London (UCL), United Kingdom
              Thomas Ryll, Immunogen, USA

This session will address emerging and enabling technologies in the area of high density continuous mammalian cell culture, cell retention devices, and linkage to the initial capture step of the product. Studies focusing on the challenges associated with high cell density culture, such as the use of highly concentrated media and the cell retention device limitations, and those aiming at improving the perfusion performance while ensuring consistent product quality are encouraged. Key questions we wish to debate in the session include: Can scale-down studies efficiently support the optimization of media consumption and improvement of cell densities? What are the challenges associated with continuous process integration down to the capture step? Can single-use technology facilitate the integration of the different process steps in a cost-effective way, ensuring long term reliability and supporting target product titers? In this session we encourage submissions addressing topics such as:

  • Scalability and robustness of cell retention devices with lessons learnt from implementation in clinical/commercial facilities
  • Concentrated versus diluted media streams and strategies
  • Scale down modeling of continuous culture and capture sequences for process characterization and validation
  • Capture step performance in context of variable feed streams
  • Linkage of continuous culture to non-chromatographic capture technologies
  • Dynamic control approaches for culture, linkage and capture step, process analytical technologies
  • Experimental and modelling comparisons of perfusion strategies with fed-batch, concentrated fed-batch and perfusion-supported fed-batch approaches
  • Cell age challenges and product quality consistency with continuous operation

Session 2: Continuous Purification and Drug Product Sequences

Chairs:  Manuel Carrondo, iBET, Portugal
               Art Hewig, Amgen, USA

This session will focus on critical aspects of “Continuous Purification and Drug Product Sequences”, including but not limited to emerging and enabling technologies, strategic technological considerations, as well as scale-down development processes and tools aimed at delivering comparable performance to at scale operations. Potential areas of interest are chromatography, filtration, viral clearance/inactivation, formulation, and drug product generation. Submitters are also encouraged to present topics not directly related to biopharmaceuticals or other biologicals in an effort to draw inspiration and create analogies from fields outside of bioprocessing, eventually including 3D drug product printing, spray drying, as well as continuous filtration and crystallization.

Session 3: End-to-end Continuous Biomanufacture

Chairs:  Massimo Morbidelli, ETH Zurich, Switzerland
               Rohan Patil, Sanofi, USA

As end-to-end continuous manufacturing in the biopharmaceutical industry gains momentum, development of key upstream and downstream technologies and integration approaches for these technologies are evolving. This session will highlight development efforts on technologies that enable end-to-end continuous biomanufacturing. These can include case studies on lessons learned from other sectors and industries, design criteria for continuous biomanufacturing, challenges for handling perturbations during continuous operations, design and execution of viral clearance studies, continuous viral inactivation (low pH and others), PAT,  process monitoring and analyses of cyclic data generated during continuous operations, technologies for continuous lyophilization or drug product manufacturing, etc.

Session 4: Business Case for Facilities of the Future

Chairs:  Nigel Titchener-Hooker, University College London (UCL), United Kingdom
              Thomas Sauer, Sanofi, Germany

We invite talks that present business cases comparing the feasibility of traditional versus continuous facilities of the future across a range of scenarios and sectors. For this session, we would appreciate any contribution that helps shed light on the following questions:

  • What is driving decisions for traditional versus continuous processes beyond company-specific considerations or product-specific needs? How big does the financial driver have to appear for ICB to win out?
  • What is the balance between CAPEX and OPEX in such decisions? How much of this is not related to single-use/disposable versus stainless steel?
  • Are there cases where both approaches have been compared using similar technology background (e.g. both modes using disposable technologies)?
  • Are there flexible approaches to allow that both modes are executable in a facility and how much does this flexibility contribute to the attractiveness of the business case?
  • Are there any known cut-off criteria that drive decisions towards ICB or stainless steel respectively? Will ICB change the paradigm that stainless steel approaches are obligatory for large volume mAbs?
  • Does ICB provide enough flexibility for fast-to-market approaches?

Session 5: Predictive Continuous QbD Case Studies

Chairs:  Naz Karim, Texas A & M University, USA
              Dorothee Ambrosius, Boehringher Ingelheim Pharma, Germany

This session will address questions regarding application of QbD concepts or tools in continuous bioprocess development and manufacturing, including scale-down, PAT, chemometrics, modeling and control. We encourage contributions that address the following topics:

  • Case studies dealing with implementation of various features of QbD
  • Case studies dealing with successes and failures of QbD. Do we see/expect specific challenges for continuous mode production?
  • Effective implementation of PAT and other technologies to improve product quality and reduce batch-to-batch variability.
  • Application of modeling frameworks and integrated control strategies in continuous manufacturing of biopharma products.
  • Use of multivariate statistical analysis in QbD.
  • Impact of QbD approach on process characterization studies.
  • Role of QbD in taking a product to market in minimal time.

Session 6: Continuous Biomanufacture Beyond CHO or Proteins

Chairs:  Chris Love, MIT, USA
              Uwe Gottschalk, Lonza, Switzerland

Many advances enabling the continuous production of recombinant proteins by mammalian hosts like CHO cells have been realized.  The benefits of integrated and continuous production should extend to other areas of biomanufacturing as well.  For recombinant proteins, alternative hosts such as microbes can offer additional advantages for simplifying or integrating unit processes such as downstream purifications.  Furthermore, the emerging challenges of producing complex biologic products like cell-based therapies or gene therapies present new opportunities to examine and develop best practices for establishing consistency and quality of products, as well as efficiencies in capital requirements where and when localized manufacturing may be required.  This session will explore these frontiers for continuous biomanufacturing beyond the conversion of existing production platforms to continuous operations.

Workshop and Poster Sessions

WORKSHOP SESSIONS

Workshop 1: Increasing Speed to Clinic with Continuous Biomanufacture    
Chairs: Todd Przybycien, Carnegie Mellon University, USA
             Jon Coffman, Boehringer Ingelheim Pharma, USA

Workshop 2: Evaluating Future Facility Design Concepts
Chairs: Suzanne Farid, University College London, United Kingdom
             Sanchayita Ghose, BMS, USA

Workshop 3: Gearing Up for Process Performance Qualification Readiness for ICB
Chairs: Mark Brower, Merck, USA
             Jeff Salm, Pfizer, USA

Workshop 4: Industry-Academia-Vendor-Government Collaboration in the ICB Space

Chairs: Alessandro Butte, ETH Zurich, Switzerland
             Alex Xenopoulos, EMD Millipore, USA

POSTER SESSIONS

Chairs:
Alois Jungbauer, BOKU, Austria
Veronique Chotteau, KTH, Sweden
Natalia Gomez, Amgen, USA
Jarno Robin, Novo Nordisk, Denmark

Conference Venue

Cascais, Portugal—Cascais is located on the Estoril Coast about 30 km west of Lisbon and is often referred to as the Portuguese Riviera.  A former fishing village, it is now a wealthy suburb of Lisbon which has a strong tourist trade for beach-loving Portuguese nationals and foreign visitors.

This portion of the European continent has had human settlements since the end of the Paleolithic era, perhaps some 35,000 years ago, as evidenced by remains at nearby Alapraia.  Much later, the Romans invaded the area in the 3rd century BCE.  Evidence of the Romans can be found in many places, including São Domingos de Rana and Casais Velhos.  There are many other sites throughout Portugal, of course, but these two are nearby.

Muslim settlers in the region, particularly in the Alentejo and Algarve regions, left their mark on local place names, including Alcoitão and Alcabideche.  Muslim control of Portugal lasted from 711 CE until 1249 CE when the Reconquista successfully ended.

Today, there is a large yacht harbor and several sandy beaches in and around the town.

Hotel Cascais Miragem–On the exclusive Estoril coast, the five star Hotel Cascais Miragem has a spectacular setting facing the Atlantic Ocean with views over the Marina of Cascais. The 192 elegantly decorated rooms and suites are spacious with all the  modern comforts.  Located on the third floor, the “infinity edge” of the swimming pool merges with the deep blue of the Atlantic Ocean. All guests have complementary access to the Health Club, Holmes Place, offering over 3000 square meter of cardiovascular and body building equipment studios with different classes and activities: heated pool with views over the ocean, Jacuzzi, sauna, Turkish bath and a service of personal trainers. Other hotel in-room amenities include free wifi, LCD flat-screen TV, mini-bar, digital safe, air conditioning, sitting area.

Only 10 minutes away by foot is downtown Cascais and its shopping and only 19 km from the ornate hilltop palace Palácio Nacional da Pena.

Hotel Address: Av. Marginal 8554, 2754-536     Hotel Phone:  +351 21 006 0600

Weather:  In September, the average high-low temperature range is 25°-17°C (77°-62°F).  Check actual weather at www.weather.com.

Things to Do in Cascais—Cascais is surrounded by popular beaches, such as Guincho Beach to the west, and the lush Sintra mountains to the north.  Some of its shorelines have cliffs, attracting tourists who come for the panoramic views of the sea and other natural sights, such as the Boca de Inferno.  It is also becoming a popular golf destination and surfing, sailing, windsurfing and kitesurfing have ideal conditions of weather, wind and sea.  The city has the ruins of a castle, an art museum and an ocean museum, as well as parks and cobbled streets of the historic center.  Taxis are a common and inexpensive mode of transport in the area.

Things to do in Lisbon—Don’t forget about the sights and activities of Lisbon, only 33 km on A6.

Transportation

By Air:  The region is served by Lisbon International Airport, located only 20 km (15 miles) away.  All major airlines are represented here.

Lisbon Airport to Cascais:  To reach Cascais from the Lisbon Airport, you can use public transport, rental car or taxi.

Public Transport

Without leaving the airport, you can take either Metro or the AeroBus shuttle to Cais do Sodré station and take the train to Cascais.

By Metro–From the airport, take the Red Line to Cais do Sodré, changing to the Green Line at the Alameda station.  See MAP.  The Metro operates from 06:30 am to 01:00 am.  Tickets are inexpensive.

By AeroBus–Instead of Metro, you can take the AeroBus from the airport to the train station, Cais do Sodré.  Take Line 1-City Center.  This service runs between the airport and train station (and return) every 20 minutes from 08:00 am until 11:00 pm daily.  Tickets are somewhat more expensive than the Metro.

By Train from Cais do Sodré to Cascais–The train fare is €2.15 for one-way, one adult.  The train fare is charged to the Viva Viagem card, which is €0.50 for the initial purchase.  It runs the entire 24 hr day and takes about 40 min. for the trip.  More information at Comboios de Portugal.

By Taxi:  The taxi fare from Lisbon airport to Cascais costs between €60-70, but the price may depend on your haggling skills as Cascais is outside the Lisbon taxi region.  They journey takes about 40 minutes, depending on traffic.

By Automobile:  It is relatively easy to drive to Cascais from Lisbon by following either the scenic N6 or faster A5. Parking in both Lisbon and Cascais is difficult and driving in Lisbon is notoriously difficult without GPS. Generally it is easier to catch the train than drive to Cascais.  Car rentals–Europcar, Hertz, Avis, and Budget are available, among others.

Conference Fees and Registration

Coming soon!

General Information about ECI

Engineering Conferences International (ECI) is a global engineering conferences program, originally established in 1962, that provides opportunities for the exploration of problems and issues of concern to engineers and scientists from many disciplines.

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

All participants are expected both to attend the entire conference and to contribute actively to the discussions. The recording/photographing of lectures and presentations is forbidden. As ECI conferences take place in an informal atmosphere, casual clothing is the usual attire.

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