Integrated Continuous Biomanufacturing III

An ECI Conference Series

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

Important Information for Participants

Final Program and Posters                   Schedule at a Glance

ICB Award Winner: Konstantin Konstantinov

Workshop Sessions

Poster Board Size:  1.5 meters high by 1.0 meter wide

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The conference will open on Sunday 17 Sep 2017 with registration from 2pm and the conference opening from 4pm with a keynote, workshops and dinner. The conferences closes on Thursday 21 Sep 2017 with breakfast 7.00-9.30am.

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 Cascais, 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.

Please prepared your abstract according to this template: docx or doc.

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: Closed

Poster abstract submission deadline: Closed

Poster Board Size:  1.5 meters high by 1.0 meter wide

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

Major Sponsors

Please click on the logo to visit the website.

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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: 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 5: 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 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
             Michael Borys, Bristol-Myers Squibb, USA

Workshop 3: Gearing Up for Process Performance Qualification Readiness for ICB
Chairs: Mark Brower, MSD, 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, Sanofi, France

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

This conference is by invitation only.  If you would like to attend, please submit a request by filling in your information HERE or by contacting the conference administrator at (kathy@engconfintl.org).

Conference Fees

All conference fees are inclusive. They include registration, accommodations (Sunday, Monday, Tuesday, and Wednesday nights), all meals (with the exception of Tuesday dinner on your own) and breaks, taxes, and gratuities from the reception and dinner on Sunday through breakfast on Thursday. Incidental fees (telephone calls, faxes, spa, laundry, etc.) are billed to your personal account by the hotel.

ALL PARTICIPANTS (INCLUDING MEMBERS OF THE ORGANIZING COMMITTEE AND INVITED SPEAKERS) ARE REQUIRED TO REGISTER.

The conference fees are:

Register on or before August 10, 2017 Register after

August 10, 2017

Participant (single occupancy or sharing room with a guest; guest fee additional) US $2,795.00 US 2,995.00
Participant (sharing a room with another participant) US $2,315.00 US $2,515.00
Bona fide Graduate Student (sharing a room with another student) (Those in this category must send proof of current status – copy of current Student ID can be faxed to 1-212-514-6030 or emailed to Kathy@engconfintl.org) US $1,895.00 US $2.095.00
**Fees for Guest/accompanying person sharing bedroom with single occupancy participant. (Includes all conference included meals) US $595.00 US $595.00

If you plan to bring children to the conference, please contact ECI (info@engconfintl.org) for pricing.

Conference Registration

You will need a login name and password to register for ECI conferences through our online system. If you have been a recent participant at an ECI conference or have submitted an online application or request for information about an ECI Conference, you may already have an account with us. If you know your login information, please use it.

If you are not sure whether you already have a login and password, please click on automated password retrieval and enter your e-mail address before creating a new account. If we don’t have a valid email address on file for you, a pop up window will appear stating that no records were found. Click “OK” and then follow the instructions to create a new account.

If you have any questions or experience any difficulties, please email kathy@engconfintl.org.

Pre/Post Conference Hotel Registration:  If you are planning to arrive early (before September 17) or to stay after the conference (After September 21), you MUST make hotel reservations directly with the hotel.  Use the appropriate form on THIS PAGE to make your reservations.

Special Notes for Payment

We suggest that you register as soon as possible to be certain that you will have a hotel room at the conference rate.  Late registrations will be accepted on a space available basis.

All participants are encouraged to register before August 10, 2017.  There is a discounted price for registering before this date and hotel space cannot be guaranteed for registrations received after this date.  Your registration is not officially confirmed until we receive payment of the amount due.  ECI reserves the right to cancel your room registration if payment is not received. Your invoice/receipt will automatically be e-mailed upon of receipt of your registration.  Should you need a signed receipt, please contact Kathy Chan (kathy@engconfintl.org).

Because of contractual guarantees made with the hotel for room and meal functions, no shows, late arrivals, missed meals and early departures cannot receive fee adjustments.  If you have a disability and may require accommodation in order to participate fully in this conference, please indicate this when you register. An ECI representative will contact you to discuss your specific needs. If you have special dietary requirements (e.g., vegetarian or a food allergy), please make a note on your registration.  The chef needs to know this information in advance if we are to accommodate you. ECI will attempt to accommodate special requests such as Kosher or Halal meals, but such meals may not be available at all conference sites. The participant must pay any additional costs for special meal requests to ECI.

Payment must be made by credit card (Visa, MasterCard, and Amex), check or money order drawn on a U.S. bank in U.S. dollars, payable to ENGINEERING CONFERENCES INTERNATIONAL. Checks or money orders in any other currencies are NOT ACCEPTABLE.  Payment must be made on the web site except for those who are sending payment by wire transfer or have a purchase order from their company/institution.

WIRE TRANSFER PAYMENT: If you are planning to make payment by wire transfer, please contact ECI for the bank information. You must add $30 to cover ECI bank charges. Please reference your full name and the conference title.  Either fax a copy of your bank transfer papers to ECI (Fax: +1-212-514-6030) or email a scanned copy to kathy@engconfintl.org.  This is very important – otherwise it is extremely difficult to trace your payment and you may not receive a receipt prior to the conference.

Cancellation Policy: Cancellation must be received by ECI in writing at least 28 days prior to the start of the conference in order for a full refund (less a processing fee) to be considered. The ECI auditors require that refunds for all conference cancellations be processed after the conference so that the necessary back-up information (e.g., hotel list of those in-house) can be attached to the refund request and ECI can verify that the hotel has not charged a cancellation fee.

Cancellation fees:

  • Cancellations received more than 28 days prior to the conference start date are subject to a processing fee of 4% of the total fee, plus any direct expenses incurred by ECI.
  • Cancellations received 15 – 28 days prior to the conference start date are subject to a $250 cancellation fee plus any direct expenses incurred by ECI.
  • Cancellations received 8 – 14 days prior to the conference start date are subject to a $500 cancellation fee plus any direct expenses incurred by ECI.
  • No refunds will be issued for cancellations received less than 7 days prior to the conference start date.
  • No refunds will be issued due to inclement weather or travel disruptions/cancellations.

Registrations may be transferred without incurring any penalty or cancellation fee.

Denied or delayed visa

If a participant is forced to cancel due to a denied or delayed entry visa, ECI will issue a full refund provided that ECI has been notified of a potential visa issue at least four weeks prior to the conference start date.

Change of payment method

If an attendee who has already paid the conference fee with a credit card requests that the fee be refunded to that card so that it can be paid in a different manner (e.g., charged to an alternate credit card, or paid via check or bank transfer), a processing fee of 4% of the total fee amount will apply.

Disclaimer

It may be necessary for reasons beyond the control of ECI to alter the content and timing of the program or the identity of the speakers. In the unfortunate circumstance that an event is cancelled, ECI is not liable for any costs incurred by participants in connection with their attendance.

Smoking is prohibited at ECI conferences and conference functions.

Should you have specific questions regarding your registration, please contact Kathy Chan (Kathy@engconfintl.org).

Final Program

Please click on This Link to view the final program and posters.

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.

Engineering Conferences International
32 Broadway, Suite 314, New York, NY 10004
T: 1-212-514-6760 F: 1-212-514-6030
E: info@engconfintl.org