Integrated Continuous Biomanufacturing IV

An ECI Conference Series

October 6-10, 2019
Ocean Edge Resort
Brewster (Cape Cod), Massachusetts

2019 ICB Award WinnerProfessor Massimo Morbidelli

Preliminary Program

Call for Abstracts:  Oral and Poster- May 7, 2019

Poster Board Size:  No more than 4 ft x 4 ft (1.22 m x 1.22 m)

Please forward this link to colleagues who may be interested in the conference topic.

USA Visa Information

About This Conference

ECI’s Integrated and Continuous Biomanufacturing Conference (ICB) is the world’s premiere conference in the area of continuous biomanufacturing. It accepts only the highest-quality scientific papers. No commercial entities influence the scientific programming.

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. The development of these technologies has been discussed in our past conferences ICB I (2013), ICB II (2015), and ICB III (2017).

ICB IV (2019) will showcase the implementation of these technologies for GMP biomanufacturing using case studies of clinical and/or commercial bioprocesses. Other topics will include:

  • Methodologies for ICB process development
  • Automation, control and digitalization strategies for ICB
  • New examples of integration between vial thaw and drug product
  • Validation of continuous viral inactivation and viral clearance
  • Continuous biomanufacturing beyond CHO and/or proteins

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.  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.

Click on This Link to view the last conference in this series.

Confirmed Speakers

KEYNOTE SPEAKERS

Susan Abu-Absi, Senior Vice President, Pharmaceutical Development & Technology, bluebird bio

“Application of Continuous Processing in Cell and Gene Therapy: Current Sate and Future Opportunities”

Manuel Osorio, Senior Scientist for Emerging Technologies and Medical Countermeasures, FDA/CBER

Advanced Manufacturing of Complex Biologics: A CBER Perspective

Session Descriptions

GMP Implementation of ICB Processes

Chairs: Nitya Jacob (Amgen), USA and Serena Di Lorenzo (Sanofi), USA

As continuous manufacturing in the biopharmaceutical industry gains momentum, approaches towards the integration of enabling technologies and implementation in a GMP environment are evolving. 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. 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. Finally, contributions focused on the challenges with scalability and robustness of enabling technologies—process intensification technologies, PAT and single use systems are encouraged.

Methodologies for ICB Process Development

Chairs: Lindsay Arnold (AstraZeneca), USA, Stefan Hepbildikler (Roche), Germany and Gerald Striedner (BOKU), Austria

Integrated Continuous Bioprocessing (ICB) can be a powerful way to increase facility utilization and productivity. This is an important contribution to the ambitious cost reduction goal in the Biopharma technology roadmap.  At the same time, the industry still has to bring new medicines to the
patients fast. Strategies for development of batch processes have been thoroughly optimized for many years to meet this requirement, and are often referred to as smart process development.

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. 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.

Digitalization and PAT for ICB

Chairs: Richard Braatz (MIT), USA, and Alex Toda (Genentech), USA

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.

Areas of interest include:

  • Advances in at-line PAT such as detection and quantification in near real time of all metabolites and critical quality attributes such as glycosylation profiles in bioreactor, or aggregates, host cell proteins, and nucleic acids in downstream processing.
  • Advances in data integration, visualization, and consumption for process development and end-to-end manufacturing processes;
  • Construction of digital twins of biomanufacturing facilities by data-driven, first-principles, and hybrid modeling to aid faster process development, more robust process transfer, and predictive maintenance;
  • Process data analytics and machine learning and AI applications to actively monitor, visualize, optimize, and control ICB processes;
  • Strategies for moving towards real-time release (RTR) testing.

Validation of ICB Processes (including Viral Clearance)

Chairs: Ana Azevedo (University of Lisbon), Portugal and Raquel Orozco (Boehringer Ingelheim Pharma), USA

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.  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). We will consider examples featuring

  • How one assures removal of impurities in the downstream system as a function of time;
  • How one ensures viral removal in the process and how it is associated with the definition of the batch;
  • How one validates bioburden control for a functionally closed system;
  • Considerations that are different for continuous and integrated processes compared to batch as they are applied to Scale-Down Model (SDM) during Process Characterization Studies (PCS) and at-scale Process Validation;
  • What tools can be are you leveraged leveraging during PCS and PV (e.g. mechanistic modeling, CFD, DOE, prior knowledge and machine learning, modular approach, PAT, high throughput screening, etc.)?

We invite papers that provide convincing evidence that support the approaches.

Case Studies on Integration of Continuous Operations

Chairs: Suzanne Farid, University College London (UCL), UK and Joseph Shultz, Novartis, Switzerland

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. 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. 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.

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. 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. Visions for rollout of these continuous platforms for regional supply of therapies and multiproduct facilities are also encouraged.

Continuous Processing – beyond CHO and/or Proteins

Chairs: Manuel Carrondo (iBET), Portugal and Scott Estes (CODIAK), USA

Continuous Processing has been used for decades for those biopharmaceuticals which are extremely labile, for example blood factors (Factor VIII, Factor VII) or enveloped viruses (Retroviruses…). More recently, also for stable protein molecules, like monoclonal antibodies to reduce footprint, improve quality and control.

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. 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.

The rationale behind and implementation of multipurpose plants designed for the novel precision medicine biopharmaceuticals of non-CHO origin will be highly welcomed for presentation.

Conference Organization

Conference Chairs:  

Veena Warikoo, Roche
Alois Jungbauer, BOKU
Jon Coffman, Astrazeneca
Jason Walther, Sanofi

Abstract Submission

Detailed session descriptions are available above.  Please use these descriptions to pre-select up to three sessions where you believe your work fits best.

Abstracts (one page maximum) that include specific results and conclusions to allow a scientific assessment of the proposed oral presentation are invited.  Please prepared your abstract according to this template: docx or doc.

Abstracts must be submitted electronically using the template provided at THIS LINK.

Oral abstract submission deadline:                     May 7, 2019
Poster abstract submission deadline:                  May 7, 2019

Poster Board Size:  No more than 4 ft x 4 ft (1.22 m x 1.22 m)

Poster pins will be supplied.

Note: Only a limited number of oral presentation slots are available and thus all submissions for oral sessions will be considered for both oral and poster presentation.

Abstracts of all presentations will be made available to conference participants prior to the start of the conference.

Awards will be presented to the top student posters, non-student posters and “short oral posters”

Interactive Workshops

Four interactive workshops will be conducted during the conference:

WORKSHOP SESSIONS

Workshop 1: Regulatory Gaps in Continuous Processing

Chairs:  Andrew Sinclair, BioPharm Services, United Kingdom and Karen Sitney, Boehringer Ingelheim, USA

Workshop 2: High-throughput Methodologies for ICB

Chairs: Marcel Ottens, TU Delft, Netherlands and Rohan Patill, Sanofi, USA

Workshop 3: Business Cases for Integrated and Continuous Biomanufacturing

Chairs: Jessica Molek, GSK, USA and Daisie Ogawa, Boehringer Ingelheim Pharma, USA

Workshop 4: Big Data analytics for Continuous Manufacturing

Chairs: Kumar Dhanasekharan, Amicus, USA and Bernt Nilsson, Lund University, Sweden

2019 ICB Award

Professor Massimo Morbidelli  

Highlights of Contributions to Integrated Continuous Biomanufacturing (ICB)

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. 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. 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.

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. 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. 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. 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. 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. 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. 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.

Massimo has recently co-authored (with 2 of his former PhD students) the book: D. Pfister, L. Nicoud and M. Morbidelli, Continuous Biopharmaceutical Processes 2018, New York, USA: Cambridge University Press.  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.

Major Sponsors

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Sponsorship Levels

Click HERE to view the levels of sponsorship available.

Conference Venue

Cape Cod extends 65 miles (105 km) into the Atlantic Ocean, with a breadth of between 1–20 miles (1.6–32.2 km), and covers more than 400 miles (640 km) of shoreline.  Its elevation ranges from only 306 feet (93 m) at its highest point, down to sea level.

One of the biggest barrier islands in the world, Cape Cod shields much of the Massachusetts coastline from North Atlantic storm waves. This protection erodes the Cape’s shoreline at the expense of its cliffs.

The bulk of the land on Cape Cod consists of glacial landforms laid down by the Laurentide ice sheet.  Geologically speaking, Cape Cod is quite young, having been created some 16,000 to 20,000 years ago.
Due to their exposure to the open ocean, the Cape and islands are subject to considerable coastal erosion.  Cape Cod’s aquifer consists of six hydrologically independent sources from which all the towns on the Cape obtain drinking water.

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.  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.  Cape Cod was among the first places settled by the English in North America.

Transportation

Airport Transportation – Sign up before August 30, 2019

Shuttle bus transportation from/to Boston Logan Airport (BOS) will be available on Sunday, October 6 and Thursday, October 10.

The cost of a roundtrip transfer is $100.00 per person. Shuttle transfers are being coordinated by Eventful Connections.

We plan to have a coach departing all 5 Logan terminals (A, B1, B2, C, E) every hour from 8:00 am through 2:00 pm on Sunday, with an additional shuttle later to accommodate those arriving later. The conference begins at 4:15 pm.

Departure times may be adjusted based on flight information provided by those signing up. Eventful Connections will email all those who sign up with additional details and instructions after the sign up deadline.

Roundtrip transfers can be booked directly here.  If you have completed your online registration, you will need to enter your email address and registration reference number.  The reference number can be found in your registration confirmation email.  If you have not registered, you will have the option to add this to your registration.

The duration of the transfer is 1 ½ – 2 hours. You will be greeted at the airport by Eventful Connections staff. Eventful Connections will email all those who sign up with additional details and instructions after the sign up deadline.

On Thursday, October 10, coaches will depart Ocean Edge Resort at various times from morning until early afternoon based upon attendees’ flight departure times.

The deadline for registrations and payments is August 30, 2019.

Alternative Transfer Options:  

If you are not planning to use the organized shuttles on Oct 6 and Oct 10 additional options are:

  • Car rentals at the airport or near the resort.  Thrifty and Enterprise have offices in Orleans, about 10 minutes from the Resort:      Thrifty-(508) 255-2234             Enterprise-(508) 255-2997
  • There are regularly scheduled buses (P&B Bus https://www.p-b.com/bus-routes/).  The closest stop to the Ocean Edge Resort is “CVS Orleans, MA”.  It is a 8 min drive to the hotel from the CVS Orleans, MA stop.

Conference Fees and Registration

Conference Fees

All conference fees are inclusive. They include registration, accommodations (Sunday, Monday, Tuesday, and Wednesday nights), all meals, excursion, and taxes from dinner on Sunday through breakfast on Thursday. The hotel will bill Incidental fees (minibar, laundry, etc.) to your personal account.

Invitation only conference

This conference is by invitation only. Invitees will be sent an email with a link to the conference registration page. To be considered for an invitation, please complete the Request for Next Mailing online application.

Note: If you have previously completed the online Request for Next Mailing, you have already been added to the list of applicants.

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

The conference fees are:

Register on or before September 20, 2019 Register after

September 20, 2019

Participant (single occupancy or sharing room with a guest; guest fee additional) US $2,720.00 US $2,920.00
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. (A guest badge will be issued and this fee includes all conference meals and the excursion) US $795.00 US $795.00

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 certain if 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 do not have a valid email address on file for you, a pop up window will appear stating that no records were located. 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-and Post-Conference Reservations

If you are planning to arrive on Saturday, October 5 and would like to stay at the Boston Logan Airport Hilton Hotel on Saturday night in order to catch the shuttle on Sunday morning, please use the appropriate form on This Link to make your reservations.

If you are planning to arrive early (before October 6 or to stay after the conference (after October 10), you MUST make hotel reservations directly with the hotel.  Use the appropriate form on THIS PAGE to make your reservations.

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

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 and late registrants may be housed in a nearby hotel.

All participants are encouraged to register before September 5, 2019.  There is a discounted price for registering before this date.  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 if 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).

Preliminary Program

Please use This Link to view the preliminary program.

General Information about ECI

Engineering Conferences International (ECI) is a not-for-profit, 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 conference provides morning and late afternoon or evening sessions in which major presentations are made. 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. 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.

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.

Smoking is prohibited at ECI conferences and conference functions.

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