Jan 29 – Jan 31, 2019
Boston, MA

Workshop A
TUESDAY, JANUARY 29, 2019

08.00 - 11.00
Establish a Robust Design and Quality Control Strategy for Industrializing Continuous Bioprocessing
Workshop Leader: Morten Munk, Global Technology Partner, NNE Workshop Leader: Niels Guldager, Global Technology Partner, NNE Workshop Leader: Tommy Alfast, Senior Process Engineer, NNE

The advantages of continuous bio-processing include increased productivity, flexibility of operations and decreased facility footprint. That being said, a detailed thought process needs to be incorporated during process control, PAT to support validation and quality assurance.

The workshop will be based on a 2018 case project for continuous bioprocessing of mAbs (monoclonal antibodies). We will use the case approach to explore key aspects of continuous bioprocessing and in this way enable interaction and networking between participants and facilitators.

The workshop will show how the control strategy can be used as baseline foundation for industrializing a continuous biotech process. Participants will get the opportunity to prototype design ideas and share their perspectives on continuous bioprocessing. The emphasis is on industrialization of continuous bioprocessing and 360 degree facility design and operations:
– Bioprocessing: state of the industry
– Upcoming bioprocessing paradigm shift
– Regulatory considerations
– Control strategy as baseline for industrialization
– Biotech facility design considerations for continuous bioprocessing
– Control strategy in action: ASTM-E2500 and industry 4.0 perspectives

This highly interactive workshop will be led by NNE’s continuous manufacturing experts. Through case studies, exercises and group discussions you will gain actionable takeaways to start implementing in your CM control strategy ensuring quality product.

Morten Munk, Global Technology Partner, NNE

Morten has over 30 years’ experience in biopharmaceutical development and manufacturing. He joined NNE in 2015 as the Global Technology Partner. Prior to that he was the VP for Manufacturing, Downstream Development and Business Development at CMC Biologics A/S.

Morten is specialized in Process Development, Facility Design, Single Use Systems, Process Validation, QbD, Tech Transfer and Regulatory Affairs.

He’s also the author and co-author of technical articles and guidelines, as well as renowned presenter at international conferences. Morten is an active member at a number of international industry associations, including ISPE and PDA.

Niels Guldager, Global Technology Partner, NNE

Niels has 22 years of experience with biotech and pharmaceutical processes. This includes hands-on experience as production engineer in large scale biopharm upstream and downstream manufacturing, and extensive project experience as process specialist, front-end study leader, process lead, and process engineer. He holds a MSc. in Chemical Engineering from Denmark’s Technical University and an Excetuive MBA from Copenhagen Business School.

His focus is process and technology in front-end project activities such as feasibility studies, conceptual and basic designs. He has a strong ability to capture customer strategy and requirements and transform these inputs to a well defined process and facility design scope. Recent projects include mAb production and development facilities, vaccine facilities and in general next generation and multi-product facilities.

Niels heads NNE Pharmaplan’s Biopharmaceuticals design group and is currently engaged in single-use technology community work for industry organisations PDA and ISPE. He is also a member of PDA’s task force for Gene and Cell Based Therapies. He holds the Certified Pharmaceutical Industry Professional™certification from ISPE.

Tommy Alfast, Senior Process Engineer, NNE

Tommy Alfast holds a Master of Science in Engineering (Biotechnology) from Royal Institute of Technology, Stockholm and Technical University of Denmark. In previous employment, Tommy has worked in different positions in Novo Nordisk A/S, including Production, R&D, Global Quality and Lean. Currently, Tommy works at the pharma engineering company NNE as Senior Process Engineer.

Workshop B
TUESDAY, JANUARY 29, 2019

15.30 - 18.30
How to Adopt Continuous Manufacturing? From Proof of Concept to Submission to Implementation
Workshop Leader: Ian Leavesley, President, Modern Pharma Consulting, LLC

Continuous manufacturing is still a new concept in pharma and biotech. The implementation will require multiple
teams’ collaboration and stakeholder management – from investment to regulatory affairs to CMC.

This workshop will help participants build a strategy and roadmap appropriate for their company to guide them from their current situation through to submission.

The workshop will include a short case study of one example of the journey taken from concept through to submission. The bulk of the workshop will be break-out sessions where participants will work with other attendees and the workshop leader to create a variety of different roadmaps to submission with key milestones along the way.

The different roadmaps will depend on different starting points, key stakeholder and supporter / skeptic identification and fit with corporate and organizational strategies. This will enable participants to leave with a fit-for-purpose strategy appropriate for their situation.

Ian Leavesley, President, Modern Pharma Consulting, LLC

Ian Leavesley is president of Modern Pharma Consulting and specializes in consulting on all aspects of drug product continuous manufacturing.  Prior to this, he initiated the continuous drug product effort at Eli Lilly, established the approach for integrating the technology with business objectives and led the process and automation components of continuous DP through to submission of Lilly’s first CM product.  He has also pursued other advanced manufacturing and data analysis technologies.

He has had multiple other roles at Eli Lilly including corporate engineering particle technology expert, QbD SME, and led the first science-based scale-up of batch wet granulation at Lilly.  Before moving to the pharmaceutical industry, Ian worked in product and process development at Procter & Gamble for 17 years.  Ian holds a BSE from Princeton University in Chemical Engineering.