Navigating Through the Global Regulatory Framework

9:00 am Chair’s Opening Remarks

9:15 am Integration Regulatory Teams in Industry CM Process Development

Synopsis

• How regulatory and Process development teams can work together to expedite speed to market
• Collaboration between internal regulatory teams and external regulatory bodies
• Enforcing benefit/risk regulatory assessment

9:45 am Panel Discussion: Where’s the Real Barrier to CM Implementation; Regulatory, Strategic or Economic?

Synopsis

• Contrasting the relative regulatory expectation for small molecule vs biologics
• What pitfalls in regulatory submissions do regulators see most often?
• Where does continuous have the most impact, small molecule, biologics? Innovators or generics?

10:30 am

Speed Networking – Get Matched With Your Fellow CCP Community Members

Small Molecules Stream

Benchmark Journeys in Pharma for Small Molecule Innovation & Future CM Strategies

11:00 am Sanofi’s Journey & Strategy for Continuous Processing for Small Molecules

Synopsis

• Ambition and execution of modular concept across R&D to Manufacturing for completion by 2025
• Strategic deployment

11:30 am FAST Impact Towards Efficient Biopharmaceutical Process Development & Manufacturing

  • Moiz Diwan Director, Head of Enabling Technology Group, AbbVie

Synopsis

• The focus on development of new modalities for advanced therapies and challenges with complex drug candidates has driven adoption of novel concepts and technologies in pharmaceutical development and manufacturing
• Industry is focusing more on flexible design concepts involving smaller footprints, shorter cycle times, high degree of automation, digitalization, and improved process control
• Enabling technologies such as continuous processing, high throughput experimentation and predictive modeling through first-principles, as well as machine learning can expedite process development, scale-up and technology transfer while ensuring enhanced process efficiency and delivering quality products
• This presentation will share AbbVie’s FAST (Flow and Automation Strategy Team) experiences in integrating these technologies into process development and manufacturing facilities and discuss the challenges and opportunities associated with our approaches

12:00 pm The Role of Continuous Manufacturing to Advance Amgen’s Synthetic Portfolio

Synopsis

• Two themes drive Amgen’s approach to the development and implementation of CM across the synthetic portfolio: 1) ‘flow chemistry’ as an enabling technology required to overcome the physical inefficiencies of large-scale batch manufacture (e.g., mixing, heat-transfer, light penetration, etc.), and 2) integrated DS processing to deliver a significantly reduced manufacturing footprint through a next-gen hybrid design.
• Presented herein are case studies where the implementation of continuous manufacturing significantly improved, or made possible, the production-scale synthesis of chemical matter across Amgen’s synthetic portfolio.

Biologics Stream

Implementing Digitalization in Bioprocessing for Advanced Process Control

11:00 am Implementing a Quality by Design (QbD) Approach in Integrated DSP Using In-line PAT Advanced Analytical Technologies to Monitor Critical Quality Attributes

Synopsis

• Continuous processing technologies and connected downstream unit operations may
require advanced analytical technologies for process monitoring and control
Evaluation of:
• Different advanced analytical technologies with the potential to accelerate process development and facilitate continuous manufacturing control strategies. The suitability of the selected techniques at scale
• The combination of outputs from different sensors in a combined manner to increase process understanding during downstream process development and reduce offline analytics and enable prediction of future platform processes
• Results of these endeavors will be presented including a critical review of the and challenges of inline analytics and processing of large data sets to increase process understanding and enable process control.
• The Resulting concept of using a process analytical technology (PAT) approach can ensure continuous processing with tight controls at all times and thus has the potential of integration into a new DSP continuous manufacturing platform

11:30 am PAT Tools for Supporting QbD-Based Continuous Bioprocessing

Synopsis

• Waters UPLC with PSM Autosampler (PATROL) for online measurements of upstream titer measurements and downstream product quality: Online and at-line modes of PATROL system provides the opportunity for near-real-time measurements of bioreactor titer and downstream CQAs. Online or at-line titer results help with the loading of the right amount of protein to the capture column. Online CQA measurements during AKTA peak fractionation helps with timely decision on peak pooling
• Agilent 2D-LC with SegFlow automated sampler: 2D-LC with compatible inline sampler enables online monitoring of titer and CQAs directly from bioreactors such that timely control of critical process parameters can be attained to bring the process in a state of control
• Agilent 2D-LC with SegFlow or comparable autosamplers helps to monitor free amino acids in bioreactors such that depleted amino acids can be supplemented timely
• μSIA system from FIA Labs: Methods such as N-linked glycan analysis requiring extensive sample preparation including sample purification, enzymatic digestion, labelling, solid phase extraction and chromatographic separation requires alternative approaches such μSIA system

12:00 pm Development & Implementation of Continuous Technologies for Biotherapeutics – An Overview

Synopsis

• Perfusion cell culture development tools
• Continuous purification skid
• PAT technologies
• Manufacturing scale and process

12:30 pm

Lunch Time Discussion Room: Pre-Competitive Collaboration

Synopsis

• What is pre-competitive collaboration and what can be gained from engaging in collaboration?
• What technology is currently being tested for implementation, how can your company help and be helped?
• How can harmonization of standards allow for better collaboration and sharing of best practice

Small Molecules Stream

Optimize Process Development for Small Molecules to Effectively Scale Up

1:30 pm Understanding and Accounting for Excipient Variability in Continuous Tablet Manufacturing

Synopsis

• Excipient variability and its effect on CM process
• Accounting for variability, the Stretch Batch approach

1:45 pm Development of a Large-Scale Cyanation Process Using Continuous Flow Chemistry En Route to the Synthesis of Remdesivir

  • Tiago Vieira Director, Process Development , Gilead Sciences

Synopsis

• Why was continuous chosen from a business case and technical perspective?
• Challenges faced when scaling up to large commercial scale manufacturing
• Lessons learned from enabling rapid sale up to meet a sudden high demand
• Finding the right external partners to work with cyanation on flow

2:15 pm Secoya Crystallization Technology: Upscaling Crystallization Processes Using a Single Reactor Type from the Lab to Production

Synopsis

• Comprehensive outlook on the paradigm shift towards spontaneous nucleation of small organic molecules in solution
• How to approach nucleation in the three dimensional space Concentration-Temperature- Hydrodynamics
• Detailed discussions on several practical case studies
• Introduction to the Secoya Crystallization product line

Biologics Stream

Process Development to Align with Next Generation Continuous BioProcessing

1:30 pm Continuous manufacturing of agarose resins and its applications

Synopsis

 

  • Jetting of uniform agarose particles
  • Cost effective purification of mAbs with Praesto jetted protein A resin
  • AVIPure affinity resins for continuous processing of non-Mabs

1:50 pm A Common Framework for Integrated & Continuous Bioprocessing

  • Jon Coffman Senior Director of Bioprocess Technologies, AstraZeneca

Synopsis

• Nearly all of the major integrated and continuous processes being implemented have a common framework that could allow manufacturing across a global ecosystem of manufacturers using simple, yet effective, equipment designs.
• The common framework is capable of supporting the manufacturing of most major biopharmaceutical ICB and legacy processes without major changes in the regulatory license.
• This talk reviews the ICB that are being used, or are soon to be used, in a GMP manufacturing setting for recombinant protein production from mammalian cells. The adaptation of the various ICB modes to the common ICB framework will be discussed, along with the pros and cons of such adaptation. The equipment used in the common framework is generally described.
• The flexibility of a plant is demonstrated with batches as small as 6kg or as large as 500kg. The yearly output of the plant is as much as 8 tons.

2:15 pm Multi-Column Chromatography Going Mainstream

2:45 pm

Afternoon Break

Designing A Winning Business Case for Continuous

3:45 pm Session Reserved for Emerson

4:15 pm A Holistic Approach to the Industry 4.0 Investment Agenda: Breaking Down the Fences Between R&D & Manufacturing

  • Christos Varsakelis Team Lead Artificial Intelligence/Machine Learning Compound Profiling, Janssen, Janssen

Synopsis

• Industry 4.0 should be understood as an investment agenda
• The usual fences between R&D and manufacturing can jeopardize the implementation of Industry 4.0 assets
• Success requires that business development treats R&D and manufacturing as a continuum

4:45 pm

Chairs Closing Remarks

5:00 pm Celebrating Half a Decade of CCP: Evening Reception Including Panel Discussion on Diversity in Pharma Manufacturing

  • Stephanie Joong Engineering & Facilities Manager, Janssen
  • Nick Thomson Senior Director, Chemical Research & Development, Pfizer Inc.
  • Tana M Session Founder & Chief Executive Officer, TanaMSession.com
  • Steven A. Lopez Assistant Professor/Board Chair, Roux Insitute Northeastern University/Alliance for Diversity in Science and Engineering
  • Madiha Khurshid Senior Associate Scientist, Amgen