INTEGRATED CONTINUOUS BIOMANUFACTURING V

Back to Barcelona: Progress & Potential of ICB

An ECI Conference Series

October 9-13, 2022
Dolce Sitges Barcelona Resort
Sitges, Spain

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About This Conference

The ICB conference series was established in 2013 in Barcelona, Spain with an international gathering of thought leaders across industry and academia to discuss and debate the promise of integrated continuous manufacturing for biological therapeutics. The biennial series continued with ICB conferences in 2015 (Berkeley, USA), 2017 (Cascais, Portugal) and 2019 (Cape Cod, USA).

Integrated Continuous Biomanufacturing V will build on this strong tradition, returning to Barcelona in 2022 in a new and larger venue, reflecting the growth of both the topic and this conference in particular. “Back to Barcelona”, where the ICB series began, we will reflect on the dramatic progress that has been made over the previous nine years: continuous technologies and strategies have been tested, proven and increasingly implemented at large scales and in clinical and commercial environments. We will also look forward to the horizon, as great potential still remains in this field. Are there additional process steps that can/should be converted to continuous operation? Are there novel enabling technologies that must be developed? What new therapeutics and modalities will benefit from the adoption of continuous and integrated processing?

The conference will also address the global pressures that are compelling companies to innovate in order to succeed in the future. Lean, fast and flexible development and manufacturing is increasingly desirable to enable (1) rapid responses to therapeutic needs on both local and global scales, (2) cost-effective processing in an increasingly competitive landscape and (3) sustainable approaches to minimize resource requirements and environmental impact.

ICB V will bring together leading scientists, engineers and experts from academia, industry and regulatory agencies who are actively engaged in integrated continuous biomanufacturing. We look forward to welcoming participants “back to Barcelona” as we and reflect on past progress and lessons learned as well as future opportunities and potential.

Conference Organization

Conference Chairs

Ana Azevedo, Técnico Lisboa
Jason Walther, Sanofi
Rohini Deshpande, Amgen

Conference Steering Committee

Mike Betenbaugh, Johns Hopkins University
Barry Buckland, BiologicB
Jon Coffman, AstraZeneca
Charles Cooney, Massachusetts Institute of Technology
Suzanne Farid, University College London
Chetan Goudar, Amgen
Guenter Jagschies, GE Healthcare Life Sciences
Alois Jungbauer, BOKU
Konstantin Konstantinov, Codiak Biosciences
Veena Warikoo, Roche 

Session Descriptions

Session 1: Continuous manufacturing of emerging therapeutic modalities

Chairs: Joseph Shultz (Evelo Biosciences), Cristina Peixoto (iBET)

Novel therapeutic modalities such as exosomes/extracellular vesicles, viruses, viral vectors, virus like particles, cells, plasmids and nucleic acids have emerged as classes of potentially promising biopharmaceuticals. While continuous manufacturing strategies for small molecules and protein therapeutics have been progressing for some time, these new entities can be decidedly more complex and may have different size and/or other biophysical attributes that may or may not make direct extension of existing techniques applicable. In this session, application of ICB strategies for manufacturing emerging modalities employing the concepts of continuous flow and integrated unit operation control strategies producing high quality and low cost biopharmaceuticals will be covered. Topics will include, but are not limited to:

  • State-of-the-art technologies in continuous upstream and downstream process
  • Integration of unit operations for continuous processes
  • Systems approaches
  • Implementation of continuous platforms covering perspectives such as scale-down mimics and cost of goods analysis
  • As-of-yet unestablished regulatory frameworks for new modalities and continuous manufacturing.

Session 2: Breakthrough ICB technologies on the horizon

Chairs: Astrid Dürauer (BOKU), Michael Coolbaugh (Sanofi)

Over the past decade, incredible breakthroughs and advancements have made integrated and continuous biomanufacturing not just a possibility, but a reality. However, most of the ICB implementations to date have focused on the conversion of “traditional” batch unit operations into integrated and/or continuous versions of the same fundamental operation. As ICB continues to mature, can we instead start thinking about disruptive innovations in process technology that are enabled by continuous processing? In this session we want to discuss technologies beyond the current state of the art. In particular, we would like to address some of the following emerging fields in the context of ICB:

  • How can we further intensify biologics production? Is the future still CHO?
  • What types of separations can be performed with ICB that aren’t feasible in batch?
  • Are there opportunities to further expand the “continuous boundary” to include additional operations?
  • How can we make biologics manufacturing more sustainable?
  • How can we best leverage high-throughput process development (HTPD), automation, and model-based scale-up to improve efficiency of development and tech transfer?

Session 3: Integrated control strategies to advance ICB

Chairs: Bernt Nilsson (Lund University), Irina Ramos (AstraZeneca)

Integrated continuous manufacturing of biologics means connecting processing units, support and control units into a manufacturing system that facilitates rapid decisions, flexible production and robust operation. A vital part in this vision is process analytical technology (PAT) that combines measurement and automation into an on-line control system to connect processing units and machines into an autonomous integrated system, with feedback of on-line measurements for disturbance rejection and on-line analytics for near real-time release.

This session focuses on PAT and on-line process control strategies for integrated processing steps and complete integrated continuous manufacturing. It also focuses on the development and implementation issues of these integrated systems. We are looking for talks on the development of enabling technologies and on case studies as well as advances in analytics, automation and control.

Session 4: Application of smart manufacturing tools to ICB

Chairs: Cenk Ündey (Amgen), Christoph Herwig (TU Wien)

In the final layout, ICB minimizes the occurrence of hold steps such as intermediate break tanks, dramatically reducing residence times, and therefore requiring new and innovative control strategies to achieve timely and controlled decisions. In the area of process analytical technology (PAT), increasingly advanced digital strategies have emerged, including the application of smart sensors (physical and soft) for monitoring, data automation, and advanced and automated process monitoring and control. However, in many cases, CQAs may not be able to be measured by PAT tools directly. Virtual replicas of the process, digital twins, will be needed to create solid links between RMAs, CPPs and CQAs as well as predict process events and allow for multiple input and multiple output feedback controls with the final goal to achieve real-time release testing (RTRT). This may also include the use of AI tools and techniques such as machine learning in the ICB manufacturing setting

This session aims at showing recent scientific advancements, showstoppers and potentials of the aforementioned smart manufacturing tools for enabling robust ICB. The audience will be introduced to novel horizontal solutions across the process chain and will learn about methods for building digital twins in a life cycle concept. Talks could also potentially cover statistical process control (SPC) and model predictive control (MPC) techniques, hybrid modeling solutions that combine mechanistic and data-driven approaches, and other industry 4.0 concepts.

Session 5: ICB strategies to address industry challenges and opportunities

Chairs: Lisa Connell-Crowley (Just-Evotec Biologics), Anurag S. Rathore (IIT)

The last decade has seen rapid growth in specialized technologies and strategies designed to facilitate integrated, continuous manufacturing of a wide range of mammalian and microbial biotherapeutics including protein, gene, and cell-based therapies. Implementation of integrated, continuous bioprocessing has the potential to reduce manufacturing time and costs, and improve the sustainability of these processes, due to significant productivity gains from process intensification. At the same time, the regulatory pathway is still relatively nascent as more integrated continuous processes are now being filed. This session will focus on case studies and strategies for managing process development and manufacturing time, understanding and improving process economics and sustainability, and navigating regulatory challenges for successful implementation of integrated continuous bioprocessing. Abstracts addressing the following questions or additional challenges/opportunities are welcome:

  1. How does continuous processing impact process productivity? What are the major factors that impact the improvement that can be achieved?
  2. How does ICB impact time to clinic and market? What strategies can be used to manage or reduce process development, characterization and validation time?
  3. How much can ICB impact the cost of manufacturing of biotherapeutics and what are the major factors influencing cost? Will this have a meaningful impact on the market price of bionovels and biosimilars?
  4. How do ICB processes compare to more traditional fed batch processes with respect to sustainability? How can we design more sustainable ICB processes and facilities?
  5. ICB offers a new paradigm for biopharma manufacturing and hence brings in regulatory complexity as well. What are the major regulatory risks and what strategies are being contemplated or implemented to overcome them?  
  6. Case studies demonstrating impact of ICB implementation on time to clinic and commercial launch, process economics, sustainability and successfully managing regulatory risks. 

Session 6: The case for ICB industrialization

Chairs: Jennifer Pollard (Merck & Co.), Andrea Rayat (University College London)

Continuous manufacturing has steadily gained traction in the biopharmaceutical industry with ongoing examples of implementation in GMP environments. As the industry facilitates more innovation and moves further into the integration of enabling technologies, the realization of integrated continuous biomanufacturing (ICB) is imminent. With this background, we aim to focus this session on the approaches to ICB industrialization with case studies on GMP design and implementation, and with contributions establishing the scalability and robustness of key technologies such as PAT and single-use systems.

We invite presentations which cover approaches to activities that support ICB industrialization such as process validation or characterization at-scale; manufacturing strategy during continuous operation including safety and quality management, digital strategy and data management, advanced process control and monitoring, GMP design considerations, and interaction with regulators.

We also encourage contributions that demonstrate industry strategies which address the challenges and opportunities en route to ICB-readiness. This can be through the development of a business case for ICB, assessment of manufacturing/technology fit, or scale-down process characterization for ICB. Presentations should contain actual case studies and real-world data to ensure content is compelling and instructional.

Call for Abstracts

All submissions should be submitted electronically HERE.

Oral presentation abstract submission:  April 1, 2022

Poster presentation abstract deadline:  April 22, 2022

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

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

Conference Sponsors

NIMBL
Eli Lilly

Call for Nominations for ICB Award

NOMINATION DEADLINE: March 31, 2022

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 and Massimo Morbidelli. 

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 
    a.) Institution (indicate major or field)
    b.) Degree received and year of each degree
  5. Positions held
    a.) Company or institution
    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, 2022. 

Questions should be submitted to Barbara Hickernell at Barbara@engconfintl.org with the subject line 2022 ICB Award Question.

Venue Information

Dolce Sitges

The Dolce Sitges by Wyndham sits in the hills above Sitges and has breathtaking views of the Mediterranean Sea. It is a modern hotel with 263 big rooms with balconies that face the pool, garden or the sea.  It is the first hotel in Spain designed specifically to host meetings and conferences.  The meeting and conference facilities are equipped with superior technology.  Its sophisticated food and beverage program that utilizes local and fresh ingredients.  The hotel features an all-inclusive complete meeting package and is an IACC-certified meeting facility.  There is complimentary wireless Internet access throughout the hotel.  The hotel also has a full-service spa and a state-of-the-art fitness center, four outdoor pools, a Finnish sauna, steam room and Jacuzzi.

Sitges, Spain 

Sitges is a coastal town in Spain’s Catalonia region, about 35 km southwest of Barcelona, backed by the mountainous Parc Natural del Garraf. It is known for its Mediterranean beaches and seafront promenade lined with grand mansions. A seaside town, Sitges boasts some beautiful beaches right on its doorstep. There are some 13 individually named beaches along a 2.5km promenade.  It has been referred to as the Saint-Tropez of Spain and the Jewel of the Mediterranean. The compact old town and surrounding streets are filled with shops, restaurants, and many nightspots.  

The town of Sitges is about a 20-minute drive from Barcelona’s El Prat international airport. There are excellent transport links to and from Barcelona airport and into Barcelona city.  For those who wish to spend some time in Barcelona either prior to or after the conference, Barcelona is easily accessible both by train and bus. The region can also be accessed from Reus and Girona airports with low cost airlines flying from many European airports.

Maricel Museum, Sitges, Spain

The Maricel Museum and Cau Ferrat Museum showcase Catalan and other Spanish art.  The Cau Ferrat building was once the home of Catalan artist Santiago Rusiñol, one of the leading figures of the Catalan Modernist movement. Upon his death, the artist bequeathed the house and its contents – including drawings, paintings, ceramics and more – to the town of Sitges on condition that it be opened to the public as a museum.

If the Old Town of Sitges is not particularly large, it is nonetheless worth exploring, in particular the old fishermen’s neighborhood and its white houses with blue borders, as well as the 15th-century Church of Sant Bartomeu and Santa Tecla and its Baroque interior.  Sitges Old Town has typically Spanish narrow streets leading down to a palm tree lined promenade that runs along an open bay with its many beaches.

Passeig Maritim


A wide pedestrian boulevard stretching along the waterfront, the Passeig Maritim is one of the most scenic walks to be enjoyed in Sitges. The walkway is lined with cafés, restaurants and ice cream shops.  The proximity to the sea is reflected in the cuisine of Sitges’ well-regarded traditional restaurants, which can be found along the waterfront and in the Old Town. The gastronomy of Catalonia is rich and varied. Principally it is the typical Mediterranean diet of fish and seafood with fresh vegetables, olives and olive oil rice and pasta.  Restaurants such as La Nansa and El Trull come highly recommended for their fresh fish as well as their hearty seafood rice dishes.

The town has been built on an industry of fishing, commerce and wine, and has been much favored by artists, the bohemian crowd and more recently has developed a large gay community.

If most people associate Bacardí Rum with Cuba, what they ignore is that the story actually begins in Spain – and more precisely Sitges – where founder Facundo Bacardí Massó was born in 1814. Today the Casa Bacardí talks of the brand’s heritage and the process of making rum, as well as offering the guests to try some rather delicious cocktails in the bar at the back.

Sitges is a maritime town. It has a large tourist infrastructure and facilities. With three local marinas, it has more than any other town in Spain. In addition to tourism, there are fishing, shoe-making, and artistic businesses, though the former now consist of smaller workshops. The town was rebuilt in the last century, to accommodate increased tourism.

Church of Sant Bartomeu i Santa Tecla, “La Punta”

Noted for its outstanding location, the Church of Sant Bartomeu i Santa Tecla, better known as “La Punta” at the end of the promenade in a bastion above steps and a coastal cliff, has become one of the most recognized icons in Sitges, much photographed and painted. Its structure is quite peculiar, because it has two bell towers, and possesses one of the watch towers that served the population to calculate the time. Its facade is quite simple but the frame where it is located is incomparable. The beautiful parish of San Bartolome and Santa Tecla is certainly the image that symbolizes Sitges. The church, built in the seventeenth century but with many subsequent amendments, is a charming Baroque style and the interior retains several Renaissance and Baroque altars and an organ of 1690.

The word Sitges means “silo” in English and it refers to the underground holes used to store wine. Before the tourist and LGBT boom of the 60s and 70s, Sitges was a wine producing fishing village big in shoemaking and with a thriving artistic and cultural scene.  The name was given by the Sitges family who took over the town in the 12th century. However, the town’s history dates back to thousands of years ago, from the Neanderthal period when it is believed that humans inhabited the caves at either end of the town. A Neanderthal jaw found in the Cova del Gegant in the 1950’s dates back to 53,200 years ago and is one of the oldest human remains in Catalunya.

Beach of Sitges, Spain

When the Spanish Civil War started, Sitges, like the rest of Catalunya, entered a dark period when all the artistic appeal and openness of the city was stopped and went into hibernation until the second half of the 20th century when things started to improve.  By the 60s and 70s, especially after Franco’s death, 75% of the population had moved from shoe making to tourism and most of the now famous festivals and cultural events that make the town proud and known were launched.  After Franco’s death in 1975 and the arrival of democracy, Sitges experienced a renewed boom. And the world famous Sitges Carnival, banned during the dictatorship, was re-established.

Sponsorship Opportunities

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.