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8:00 am Registration & Welcome Coffee

8:15 am Chair’s Opening Remarks

8:30 am Opening Address: The New Launch: CBER’s Advanced Manufacturing for Complex Biologics Products

  • Manuel Osorio Senior Scientist & Program Lead for Emerging Technologies, FDA/CBER

Synopsis

  • The newly created organization within CBER to support and promote emerging technologies adoption within pharma and biotech
  • Gain early access to engage with the FDA to ensure a smooth drug development and approval process
  • Dissecting the myths and misunderstandings of closed door operations
  • Q&As

9:00 am Continuous Manufacturing as a Default Platform for Oral Solid Drug Products

Synopsis

  • Market activities in continuous manufacturing and evolving regulatory support
  • The reality of a flexible Supply chain – and the impact of regulations
  • How can a manufacturing leader anticipate a volatile drug development portfolio?

9:30 am The Possibility of End-to-End Implementation of Continuous Manufacturing – From Development to Supply

  • Justin Moser Director – Advanced Manufacturing Technology, Merck & Co., Inc.

Synopsis

  • Merck’s CM journey so far – how to realize CM platforms for oral small molecule drug products
  • Can we introduce CM from development to supply? The importance of a business case to demonstrate value proposition
  • Our pilot case study on batch vs. CM comparison
  • Looking forward – what are the opportunities?

10:00 am Panel Discussion: Is Continuous Manufacturing for Legacy Product Only? Can we be Courageous and Use it for NDA?

Synopsis

This year’s panel discussion will be focused on discussing CM strategies and how they relate to:

  • Streamlining process analytics: What is the role of process analytics for a legacy product and a new product? What role does the process analytics strategy play in the process verification strategy?
  • Ensuring rapid ‘fume hood to launch’: How can thoughtfully designed processes and work spaces, along with modular equipment, support rapid development for an NDA? Does this approach impact a legacy product? How can we foster a culture of collaboration that recognizes how we work and where we work, as well as the importance of hardware and software to enable CM?
  • Matching batch size to demand: What should be considered to achieve the ability to deliver supply small batches quickly and with consistent quality? What impact does an ever-changing supply chain have on the CM strategy for meeting current needs and project needs?
  • Achieving stakeholder engagement: Who are the stakeholders and what matters to them when deciding whether to pursue a legacy product or an NDA approach for CM?

10:45 am Speed Networking & Morning Coffee

Small Molecules Stream

Biologics Stream

11.45 am End-to-End Continuous Flow Chemistry Process to Increase Production Efficiency

Miguel Gonzalez, Senior Director, Chemical Engineering, Asymchem

12.05 pm Application of Continuous API Manufacturing Technologies at Pfizer

• The importance of quality by design in API development and manufacture

• The role of modelling in process development and design of continuous processes

• The application of modelling to the design of plug flow reactor and continuous stirred tank reactor processes

• Selected case histories to exemplify key points

Nathan Domagalski, Senior Principal Scientist, Pfizer Inc

11.45 am Towards Continuous Drying Technologies for Parenterals

• From continuous manufacturing drug product to assessing the possibility of continuous freeze drying

• Rational behind choosing this unit process - costs of goods, technology requirements and benefits

• Early lessons learned and next steps

Sune Klint Anderson, Principal Scientist, Janssen R&D

12.15 pm A Continuous and Controlled Pharmaceutical Freeze-Drying Technology for Unit Doses

• A continuous and controlled freeze-drying technology for unit doses to preserve biopharmaceuticals has been developed and will be presented

• How continuous freeze-drying technology offers clear advantages over current batch production such as cost reduction (up to 50%), track-and-trace product quality control at unit dose level, and a significant reduction of processing time (> 40 times faster, e.g. 1 hour instead of 5 days at a vial level), reduced need for clean room and a substantial sustainability gain

• Results of feasibility studies using this new technology with different types of biopharmaceuticals

Thomas de Beer, Head of Laboratory of Pharmaceutical Process Analytical Technology, University of Ghent

12:45 pm Networking Lunch

1:15 pm

13.15 pm Flexible API Supply Technologies; Pfizer’s Strategy for API Continuous Development and Manufacturing

• Roadmap to-date – the business case for continuous and our path to building capability

• Benefits of deploying continuous manufacturing for API to secure greater agility

• Our strategy for portfolio impact and development of a modular library of technologies

• Next steps

Nick Thomson, Senior Director, Chemical Research & Development, Pfizer Inc.

13.45 pm Innovation on OSD Continuous Manufacturing Platform

Session Reserved for Innovation Partner

14.15 pm Commercializing New Chemical Technologies in Flow

• Abbvie’s approach toward implementing flow technology

• Scaling and commercializing visible light photoreactors

• Scaling and commercializing electrochemical reactors

Kaid Harper, Senior Scientist, AbbVie

13.15 pm Design of Jetted Protein A Resins for Continuous Chromatography

• Scalable, continuous ‘Jetting’ technology to produce beads with a narrow particle-size distribution

• Considerations of dynamic binding capacity (DBC), purification performance, cleaning in place (CIP) and fouling of chromatography resins

• Proven data to demonstrate improved process economics in commercial manufacturing

Hans Johansson, Global Applications Director, Life Sciences, Purolite

13.35 pm Continuous Bioprocessing for Exosomes Manufacturing –
Upstream Case Study from Codiak Biosciences

  • Case study for scaling up a perfusion process for exosome manufacturing to clinical manufacturing scale
  • Comparison of productivity and product quality attributes of exosome manufacturing in fed-batch and perfusion modes
  • Implementation of process analytical tools to achieve steady state VCD profiles in perfusion process

Joon Chong Yee, Associate Director, Upstream Process Development, Codiak Biosciences

14.05 pm Session Reserved for Program Partner

2:45 pm Afternoon Networking Tea & Poster Session

3:30 pm Creating a Common Language and Framework to Support Continuous Manufacturing Globally

  • Ganapathy Mohan Executive Director, Head of External Affairs (Quality), Merck & Co., Inc.

Synopsis

  • Product quality and CMC definitio
  • ICH Q13 draft guidance – what is the status quo and where are we with the guidance development?
  • Continuous manufacturing in GMP environment
  • How to harmonize and standardize across the world?
  • What’s next?
  • Q&A

4:00 pm Continuous Downstream Processing – Where Are We in Regard of Comparability and Regulatory Challenges?

  • Klaus Kaiser Head Downstream Development, Product Supply, Pharmaceuticals, Bayer AG

Synopsis

  • Reason for continuous manufacturing? From cost efficiency, reliability to scalability and facility footprints for manufacturing of biopharmaceuticals
  • How can continuous manufacturing better support demand changes from clinical to launch and for volatile market dynamics?
  • Gap analysis
  • Design aspects
  • Product comparability
  • Transfer from batch to continuous
  • Regulatory aspects
  • Illustrate comparability of CM vs. batch processing in a side-by-side approach covering process information, real time analysis and quality data from intermediates and final drug substance of an antibody product

4:30 pm Roundtable Discussion:

Synopsis

  • How to handle a volatile pipeline and commit to manufacturing decisions?
  • Exploring continuous manufacturing for NDA and legacy products
  • Setting KPIs for CM – MSAT vs. Manufacturing vs. Plant/ Site Heads

5:15 pm Chair’s Closing Remarks & End of Day 1

5:30 pm Poster Session