Integrated Continuous Biomanufacturing IV

An ECI Conference Series

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

Mark Your Calendar!          Request for Next Mailing

Call for AbstractsOral- April 30, 2019; Poster May 7, 2019

USA Visa Information

Request for Nominations for the 2019 ICB Award!

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

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

Michael P. Angelastro, Director, Division of Pharmaceutical Countermeasures Infrastructure [PCI], Biomedical Advanced Research & Development Authority [BARDA], Assistant Secretary for Preparedness & Response [ASPR] , U.S. Department of Health & Human Services

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: 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, Alessandro Butte (ETH Zurich), Switzerland 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: Scott Estes (CODIAK), USA and Manuel Carrondo (iBET), Portugal

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, Boehringer Ingelheim
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:                     April 30, 2019

Poster abstract submission deadline:                  May 7, 2019

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: Ingrid Markovic, Genentech, USA and Cristina Peixoto, iBET, Portugal

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 Dhaneshakeran, Amicus, USA and Bernt Nilsson, Lund University, Sweden

Sponsorship Levels

Click HERE to view the levels of sponsorship available.

2019 ICB Award

Guidelines for the 2019

Integrated Continuous Biomanufacturing Award

NOMINATION DEADLINE: March 31, 2019

PURPOSE

The Integrated Continuous Biomanufacturing (ICB) Award recognizes an outstanding contributor to the field of Integrated Continuous Biomanufacturing. The award was initiated in 2017 and the first recipient was Konstantin Konstantinov.

The award nominations will be judged according to criteria as set forth in this document.

AWARD

For each conference, an award of cash and a commemorative plaque will be presented to the recipient at the conference.   Engineering Conferences International (ECI) sponsors this award.

ELIGIBILITY

This Award is open to all researchers in integrated continuous biomanufacturing. The award recipient is expected to register and attend the conference.

EVALUATION

A committee established by ECI will evaluate the nominations and make the final decision.

CRITERIA

The committee will judge the nominations on the originality and overall quality of work, significance to the advancement of the field of integrated continuous biomanufacturing, and other supporting information in the nomination package.

NOMINATION PACKAGE (All documents should have 1 inch margins all around and use font no smaller than Arial 10 or Times 12 point):

The nomination package must consist of the following items:

1) A nomination cover sheet;
2) A nomination letter of no more than 3 pages including a description of the nominee’s contribution to integrated continuous biomanufacturing;
3) A resume including publications by the nominee (preferably fewer than 10 pages); and,
4) A maximum of three supporting letters from individuals in the field

The nomination cover sheet should contain the following information if not already included in resume:

1) Name of nominee
2) Present position (exact title)
3) Mailing address (including telephone and email)
4) Education

  1. a) Institution (indicate major or field)
  2. b) Degree received and year of each degree

5)  Positions held

  1. a) Company or institution
  2. b) Position or title (with time period, if possible)

6)  Academic and professional honors and awards
7)  Technical and professional society memberships and offices held
8)  Nominator’s name and address (including telephone and email)
9)  Nominator’s signature and date

Please submit the complete nomination package (including scanned, signed letters of support) in an electronic form as a single PDF file with the subject line ICB Award Nomination-name of nominee and send to Barbara@engconfintl.org.

Nomination packages are due by midnight EST March 31, 2019.

Questions should be submitted to Barbara Hickernell at Barbara@engconfintl.org with the subject line 2019 ICB Award Question.

Printable Copy of the Guidelines

Major Sponsors

Lilly master brand logo, JPG format, RGB (red), desktop publishing -- printing on a desktop printer or color copier

 

 

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

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Conference Fees and Registration

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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
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