Integrated Continuous Biomanufacturing VI

An ECI Conference Series

October 20 – 24, 2024
Lansdowne Resort & Conference Center
Leesburg, Virginia

Digital Archives
ICB V Presentations & Abstracts

About This Conference

The Integrated and Continuous Biomanufacturing (ICB) Conference is ECI’s premiere international conference in continuous and integrated biomanufacturing. As global competitive pressures continue to force companies to innovate to succeed, integrated continuous processing creates opportunities to accelerate process development and reduce manufacturing costs while enhancing flexibility and product quality. Ultimately, these collective improvements in efficiency and quality will help us better achieve our primary objective in the field – to increase patient access to transformative therapies. 

Impressive technological advances have been made over the past decade to enable the implementation of continuous bioprocessing. ICB VI aims to build on the strong momentum generated in previous conferences of this series by developing an exciting and engaging program showcasing progress in implementation of integrated continuous biomanufacturing technologies for GMP biomanufacturing via case studies of clinical and commercial bioprocesses. ICB VI will highlight progress across the ICB discipline, including areas related to Regulatory Affairs, Simplification, Emerging Therapeutic Modalities, Process Analytical Technology (PAT), Sustainability, as well as Modeling, Automation, and Control. 

ICB VI will bring together leading scientists and engineers from academia, industry and regulatory who are actively engaged in creating and enabling integrated continuous biomanufacturing. We look forward to welcoming invitees to Leesburg, Virginia, USA to reflect on the field’s progress and to harness our collective capabilities to drive towards a more efficient and sustainable future. 

On behalf of the ICB Conference Steering Committee, we are also pleased to announce that ICB VII is planned to occur in Europe in the Fall of 2025. This will return the biannual conference series to ‘odd’ calendar years. Additional details on organization and site selection will be shared at a future date. 

Sincerely, 
Ana Azevedo, Kevin Brower, Aaron Noyes

Conference Organization

Conference Chairs

Ana Azevedo, Instituto Superior Técnico, Portugal
Aaron Noyes, Apogee Therapeutics
Kevin Brower, Sanofi, USA

Session Descriptions

Advances in automation, process control, and PAT that enable expanded ICB deployment

Chairs:
Anurag S. Rathore, Indian Institute of Technology Delhi
Leon Pybus, FUJIFILM Diosynth Biotechnologies

ICB based approaches provide a step-by-step transition from batch to more continuous modes of operation by either intensifying single unit operations or integrating process steps with the ultimate vision of fully automated flow-through continuous processing. The actual requirement for optimized clinical and commercial manufacturing may lie somewhere in between an end-to-end batch and fully continuous flow-through process. Nonetheless, increased ICB operation increases system and technology complexity, necessitating greater automation orchestration and control. Furthermore, ICB could allow real-time release testing of the drug substance or drug product. However, this vision requires the implementation of process analytical technologies (PAT) to identify and control processes when unplanned deviations in feed or raw material attributes occur.

Therefore, this session will focus on automation, process control and PAT that pave the way for more intensified ICB and drug substance real-time release. Priority will be given to submissions that present implementations into commercial or clinical manufacturing environments. Subtopics of interest include process monitoring, process modeling, in-process analytics, digital twins and data analytics with an ICB context.

ICB Convergence: Case Studies in Simplification and Standardization

Chairs:
Elizabeth Goodrich, MilliporeSigma 
Joanna Pezzini, PAK BioSolutions

While continuous processes are more complex than batch due to a high level of dependence between simultaneously operating steps, the industry has made steady gains to recognize areas for improvement and address challenges.  Companies are probing strategies to balance the ideal of a fully continuous process with the pragmatic introduction of simpler intensified processes that deliver a similar level of benefit.  Much like a standardized process template and readily available full-scale systems enabled the dramatic expansion and simplification of batch mAb processing, technologies and process knowledge for continuous processing are currently maturing to drive increased implementation of fully connected and continuous processes. 

In this session we would like to highlight progress within the industry, and particularly across multiple companies and vendors, where simplification and standardization of equipment, single-use technologies, digital strategies, and/or automation have enabled intensified processing and have resulted in improved efficiency, flexibility, and performance.

We invite contributions that demonstrate implementation of continuous processes across multiple unit operations and discuss strategies for and challenges with the interconnection of these steps.Presentations that demonstrate the use of modeling to solve real-world problems of intensified process design and control are also encouraged; these may include tools and other efforts to evaluate mass and flow balances, residence time distributions, hardware sizing, and consumable sizing based on cadence. Discussion is welcomed on areas where the industry could benefit from additional standardization to lower the hurdle of achieving a continuous process.

ICB GMP Implementation: Celebrating Achievements and Lessons Learned

Chairs:
Lara Fernandez-Cerezo, Merck & Co.
Jun Tian, WuXi Biologics

Traditional biologics manufacturing processes in a batch mode are generally costly and time-consuming.  Continuous processing on the other hand may produce higher productivity with greater consistency in product quality, and may reduce equipment and facility footprint significantly lowering capital and manufacturing costs. As such, Integrated Continuous Biomanufacturing (ICB) has been gradually and steadily adopted in the biopharmaceutical industry for clinical or commercial manufacturing in GMP environments. 

In this session, we aim to cover industry advances when implementing ICB into GMP operations, but also encourage talks to cover the challenges experienced during the adoption and their mitigation strategies.

More specifically, we invite cross-functional talks encompassing ICB process tech transfer; ICB equipment and process validation; ICB equipment sizing, facility design and construction; and notably differences and considerations between clinical and commercial ICB processes.

Strategic case studies will also be fostered in this session, covering for example consumables, material management and supply/demand projections performed for ICB-manufactured products.

We are striving towards a session based on real-world case studies with multi-disciplinary talks leveraging input from different functional areas such as process development, regulatory, operations, supply chain, commercialization, validation, process automation, procurement and quality teams.

Leveraging ICB for a Sustainable Future

Chairs:
Sara Badr, University of Tokyo
Kerry Love, Sunflower Therapeutics

Enabling advances in biotechnology to address the needs of our growing global population will require reexamination and adaptation of legacy biomanufacturing approaches, including ICB. Ensuring sustainability requires balancing the three pillars of environmental, social, and economic development. What is the role of ICB in realizing a more sustainable future?

In this session, we invite presentations that address the following topics:

1)    Modeling the impact of the industry: What is the industry’s environmental footprint and how can we reduce it? What innovations can help conserve resources and raw materials? What are the sustainability indicators to best describe the impact of biopharmaceutical production?

2)    Tradeoffs in and among sustainability pillars: What are the choices biomanufacturers are making between environmental, social and economic impact? How can they be quantified and resolved? How could ICB factor into decision making to reduce compromise overall?

3)    Material developments: What innovative process materials can reduce footprints? How can different stakeholders (suppliers, process developers,..) incentivize changes towards these innovations while balancing risk?

4)   Addressing the social impact: What is needed from the industry to ensure the well-being of global communities? How can ICB be leveraged for sustainable in-region production of diverse products, including new business models that encourage bioeconomy growth?

5)      Industrial biotechnology and alternative foods: How can ICB expand its relevance to alternative foods, enzymes and other commodity biotechnology products? What are the potential negative impacts of large-scale production of cellular agriculture and precision fermentation and how can ICB mitigate these?

6)  Regional, and regulatory aspects of sustainability: What is the role of the regulators in developing more sustainable processes and products? What are the implications of regional constraints on global production?

Regulatory Science for Integrated Continuous Biomanufacturing

Chairs:
TBA

As ICB continues to progress towards implementation across the industry, Regulatory Science will play an increasingly critical role to further adoption of ICB technology across a broad range of processes, modalities, and companies. Foundational relationships have been established via a range of regulatory forums and means of interaction, whether via informal health authority engagement, participation in consortia, or formal engagements across INDs, BLAs, and MAAs. Accordingly, a significant body of concrete ICB cases have emerged demonstrating the applicability and adaptability of current regulatory frameworks to enable the development and both clinical and commercial implementation of ICB to manufacture medicines for patients. 

In this session, we welcome case studies describing regulatory engagements for the implementation of ICB technology in practice. These case studies may describe work done to establish and apply regulatory strategy within a development program or in cross-industry consortia. Case study examples may include description of IND filing strategy, including approaches for engagement in new technology forums (such as, but not limited to ETT and CATT), preIND meeting strategy and corresponding briefing book development, and strategy or examples of responses to questions posed by health agencies during Type C, IND, or BLA/MAA activities. 

Additional topic areas may also include regulatory considerations and associated case studies for conversion between batch, hybrid ICB, and more fully continuous applications of ICB technology, including related comparability paradigms. Case studies describing experiences preparing for inspection, such as by internal audits or mock inspections are of particular interest as are descriptions of common themes across agencies and key heterogeneity experienced during global regulatory submissions. 

Submissions are welcome from all members of the regulatory science continuum, including applicants (innovators, CDMOs, etc), health authorities, vendors, and academia. In all cases, preference will be given to abstracts that include specific case studies that detail ICB and regulatory science in practice

What’s new(er): Applications of ICB for Emerging Modalities

Chairs to be confirmed

Novel modalities, including cells (cell therapies, cultured meat, seafood, dairy and eggs), viruses and viral vectors, bionanoparticles (LNPs, extracellular vesicles, virus-like particles) and nucleic acids (plasmids, mRNA) have emerged as a promising new class of biotherapeutics. While impressive advances have been made in continuous manufacturing strategies for small molecule and protein therapeutics, these new entities introduce complexities with varying sizes and biophysical properties requiring a re-evaluation of current technologies.

Join us for this session dedicated to the application of ICB strategies to the manufacture of new modalities, now including the exciting field of cellular agriculture. We will explore concepts of continuous flow and integrated unit operations control strategies aimed at producing high quality, cost effective bioproducts. Topics will cover a broad spectrum, including but not limited to:

  • State-of-the-art technologies in continuous upstream and downstream processes applied to emerging modalities
  • Integration of unit operations for continuous processes, including novel approaches to accommodate unique challenges encountered with emerging modalities
  • Bespoke PAT and control strategies necessitated by the unique properties of the modality
  • Systems approaches to improve efficiency
  • Implementation of continuous platforms with perspectives such as scale-down models and cost of goods analysis
  • Navigating the evolving regulatory frameworks for new modalities and continuous manufacturing

Workshop Descriptions

Call for Abstracts

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

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

Oral and Poster Abstract Submission Deadline:               April 19, 2024      

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

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.

Conference History

Integrated Continuous Biomanufacturing

October 20 – 24, 2013, Castelldefels, Spain
Conference Chairs: Konstantin Konstantinov, Genzyme-Sanofi, USA; Chetan Goudar, Amgen, USA; Nigel Titchener-Hooker, University College London, UK

Integrated Continuous Biomanufacturing II

November 1 – 5, 2015, Berkeley, California, USA
Conference Chairs: Chetan Goudar, Amgen, USA; Suzanne Farid, University College London, UK; Christopher Hwang, Genzyme-Sanofi, USA; Karol Lacki, Novo Nordisk, Denmark

Integrated Continuous Biomanufacturing III

September 17-21, 2017, Cascais, Portugal
Conference Chairs: Suzanne Farid, University College London, UK; Chetan Goudar, Amgen, USA; Paula Alves, IBET, Portugal; Veena Warikoo, Axcella Health, Inc., USA

Integrated Continuous Biomanufacturing IV

October 6-10, 2019, Brewster (Cape Cod), Massachusetts, USA
Conference Chairs: Veena Warikoo, Roche, USA; Alois Jungbauer, BOKU, Austria; Jon Coffman, AstraZeneca, USA; Jason, Walther, Sanofi, USA

Integrated Continuous Biomanufacturing V

October 9-13, 2022, Sitges, Spain
Conference Chairs: Ana Azevedo, Técnico Lisboa, Portugal, Jason Walther, Sanofi, USA, Rohini Deshpande, Amgen, USA

Conference Sponsors

ICB Award

Nomination Deadline

March 31, 2024

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 previous recipients are Konstantin Konstantinov, Massimo Morbidelli and Veena Warikoo.

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.

Eligbility

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
    • Institution (indicate major or field)
    • Degree received and year of each degree
  5. Positions held
    • Company or institution
    • 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, 2024.

Questions should be submitted to Barbara Hickernell at Barbara@engconfintl.org with the subject line 2024 ICB Award Question.

Sponsorship Opportunities

Special Issue of Biotechnology Progress

We are excited to announce that there will be a special issue on “Integrated Continuous Biomanufacturing” in Biotechnology Progress. This issue aims to capture recent advances in ICB, including topics that were presented and discussed at ICB V in Barcelona in 2022. The submission deadline is July 1, 2023. If you have questions, please contact Jason Walther at jason.walther@sanofi.com.

Conference Fees and Registration

Venue Information

The conference will take place at the Lansdowne Resort and Spa

44050 Woodridge Parkway
Leesburg, VA 20176

This AAA Four Diamond award-winning resort is the Mid-Atlantic’s premier destination for conferences with unmatched service and facilities, a beautiful terrace with panoramic views of the grounds and golf course,  experienced staff and outstanding guest room accommodations. Lansdowne, located on 500 picturesque acres, is recognized as a Virginia Green Lodging facility. The resort is only about 12 miles from Dulles Airport and about 30 miles outside of Washington, DC.

Landsdowne Governor's Suite

Lansdowne has on site high technology conference support, complimentary high speed WiFi coverage throughout the resort and most of the 36 meeting rooms are organized in a compact conference center format for maximum flexibility.  In addition, the conference facilities include refreshment kiosks that are far above the standard coffee break and are available throughout the day.

Conference participants will have complimentary use of the 24-hour fitness center, hot tubs, sports courts, indoor (and seasonal) outdoor pools, billiards, fire pits and bikes (based on availability).  Water activities include kayaking and fishing on the Potomac River.

Landsdowne Restaurant

Each guestroom has bottled water, Lavazza coffee and coffeemaker, tea, HD LCD TVs, bathrobes, hair dryer and quality bath amenities. All guestrooms are non-smoking. Lansdowne also has a spa (Spa Minérale) which offers traditional spa services.  It features relaxation lounges, steam rooms, dry saunas, whirlpools and hair, makeup and nail services.

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.

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