DAY ONE

07.45 – 08.30

Registration

08.30 – 08.40

Welcome & Chairman’s Opening Remarks for Day One

08.40 – 09.15

Current Trends in the Biotech Industry – Where Are We Now? Where Are We Going?

  • With the volatile political landscape in the US, how can companies overcome the various roadblocks facing them; regulatory hurdles, financing considerations, the threat of biosimilars and the evolving patent landscape.
  • In this engaging keynote, Rakesh Dixit will discuss how Medimmune is developing disruptive technologies, next gen manufacturing processes and strategies to minimise costs, maximise productivity and remain ahead of the curve in rapidly evolving times

09.15 – 09.50

Integrating next-gen processes, technologies and operations to modernise biomanufacturing

  • The growth of biologic therapeutics demands innovations in biomanufacturing to supply drug products in a more reliable and faster manner
  • Modernised approach to biomanufacturing with Next-Gen Manufacturing (NGM) integrations
  • Combing the NGM mode with modular, expandable facility design and automation

09.15 – 09.50

Biomanufacturing of the future – Which technologies for the benefit of the patient?

  • Major transformation of BioManufacturing and emerging new and game-changing technologies, such as continuous E2E manufacturing, disposable equipment and digital plants
  • Which new technologies are just “passing fads” and which game-changing technologies will bring real benefit and added value to the patient?
  • Technologies are sometimes incompatible or contradictory, e.g. disposable technology, requiring more manual handling, and plant digitalisation, aiming at self-driving operations
  • Is there a “one-size fits all” biomanufacturing plant of the future? Should the biotech industry work towards a common technology platform similar to that developed by the semiconductor industry a few decades ago?

09.50 – 10.40

COFFEE BREAK & MEETINGS

Downstream Processing

Upstream Processing

10.40 – 11.15

Validation of next gen depth filter technology in a commercial downstream process

  • Current situation
  • Proposed situation
  • Small scale development
  • Upscaling and Large scale validation
  • Conclusion and take home messages

10.40 – 11.15

Common denominators of process and life cycle control strategies

  • Capture your process knowledge in Digital Twins
  • Accelerate time to clinic by Digital Twin controlled experimental designs
  • Deploy your knowledge in real time model predictive control architectures enabling continuous manufacturing
  • Identify holistically relevant process parameters and anticipate life cycle variabilities using integrated digital twins

11.20 – 11.55
Disposable Technology applications to support an evolving product pipeline.

  • Introduction of high potency Bispecific to standard product portfolio.
  • Conventional cleaning methods not feasible
  • Design of disposable manufacturing options for 100% of upstream downstream unit operations
  • Develop calibration philosophy for disposable instruments
  • Deliver capability within 8 months to support clinical trial program

11.20 – 11.55

Advancing Late Stage Cell Culture Concept and Leveraging Platform Knowledge

  • Risk assessment in Late Stage process development
  • Scale down models – Production bioreactor and beyond
  • Advancing Process Characterization Studies
  • Towards Late Stage Knowledge Management

11.55 – 12.55

One to One Meetings

  • Downstream/Upstream Process Technology Platforms
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Smart Manufacturing Technologies – Technology Transfer
  • Facility Management & Integration
  • Capacity & Facility Design
  • Multi product facilities
  • Energy & Operational Efficiency
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain
  • Microbial Process Development and Production

11.55 – 12.25
Using systematic tools to expedite PC and maximise reliability of PPQ campaigns

  • Emphasising the science of the control strategy
  • Focuses attention on critical process understanding
  • Efficient, thorough, and useful process characterisation designs
  • Confidence that equipment controls are optimized
  • Maximise reliability for PPQ, PAI, commercial manufacturing

12.25 – 12.55

Future Trends Perspectives and insights on Biomanufacturing

  • Major market trends, market growth and new modalities
  • Risk factors in biomanufacturing
  • Capacity planning: new approaches and technologies
  • Process intensification

12.55 – 13.45

NETWORKING LUNCH

Downstream Processing

13.45 – 14.20

Overcoming mAb manufacturing process challenges for high concentration drug substance to facilitate subcutaneous administration

  • UF/DF recovery flush strategy to enable high yields
  • Targeting excipient concentrations in UF/DF processes
  • UF/DF pressure limitations due to high viscosity
  • Sterile filtration challenges at high protein concentrations
  • Stability considerations at high concentration drug substance

Upstream Processing

13.45 – 14.20

Streamlining the Technical Operation Platform to Accelerate Biologics Development and Reduce Manufacturing Cost

  • Improvement of technical platform including cell line, cell culture media, and purification framework.
  • Harmonization of core platform including cell culture, purification, and analytics.
  • Implementation of automated high-throughput operation
  • Best practices in scaling and technology transfers

14.25 – 15.00

Downstream Development and Scale-up Challenges for High-Titer Cell Culture Processes

  • Minimal in-process pool volume and load adjustment/preparation
  • Robust impurity clearance and risk-based development strategies
  • Manufacturing facility fit and process development considerations
  • Scale-dependent challenges and model-assisted solutions

14.25 – 15.00
Novel Methods to Ensure pH Comparability Globally Independent of Scale and Outlook for Manufacturing

  • Discuss pH as CPP and relevant parameter in scale up, SDM and process transfer
  • Problem statement for sample based pH offline measurement
  • Presentation of a novel method to ensure pH comparability globally independent of scale
  • Discuss implementation into manufacturing and outlook

15.05 – 15.40

Leveraging ICB and at-scale development for a diverse biologics portfolio

  • Integrated and continuous biomanufacturing (ICB) can enable process intensification and process development at manufacturing scales
  • This presentation will highlight a Sanofi case study on the commercialization of an ICB process (for unstable molecule) that demonstrates the benefits of at-scale development
  • A second Sanofi case study on strategic considerations of choosing an ICB process for a stable molecule will also be presented

15.05 – 15.40

Development of An Intensified Manufacturing Process for Single-Use Clinical Manufacturing Facility

  • New clinical manufacturing suite in Devens site has been built with the intention of implementing a hybrid continuous manufacturing model that can increase monoclonal antibody output
  • In the upstream process, a perfusion process has been developed for the seed train to increase cell densities of fed-batch process, reduce cadence and enhance annual antibody output. The perfusion seed train implemented the use of capacitance probes to control perfusion rate and minimize media utilization.
  • Accompanying high density fed-batch process, a new platform media has been developed for basal and feed to enhance productivities.
  • A clone selection workflow has also been adapted to accommodate the transition to a high density fed-batch process from the previous fed-batch platform approach.

15.40 – 16.30

COFFEE BREAK & MEETINGS

16.30 – 18.00

One to One Meetings

  • Downstream/Upstream Process Technology Platforms
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Smart Manufacturing Technologies – Technology Transfer
  • Facility Management & Integration
  • Capacity & Facility Design
  • Multi product facilities
  • Energy & Operational Efficiency
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain
  • Microbial Process Development and Production

16.30 – 17.00

A New Generation of Agarose Beads

  • Next generation resin for downstream processing
  • Advanced resin technology for continuous and batch manufacturing
  • Increased process productivity & economy
  • Ultra-high capacities on Protein A resin above 80 g/l

17.00 – 17.30

Evolution of a Next Generation, High-Intensity Manufacturing Process

  • System Overview
  • System Evolution
  • Key Accomplishments
  • Microbial Control

17.30 – 18.00

Using Alluvial Filtration as an Effective and Economical Solution for Midstream Clarification

  • Alluvial filtration compare to other technologies
  • Economic approach for Midstream 7 Clarification
  • Robust technology – easy scalable

18.05 – 18.35

Open Panel Discussion: Technical Life-Cycle Management and Post-market authorization changes

  • Technical Life-cycle management activities and ICH Q12, more upfront planning required
  • Post-market authorization changes, flexible manufacturing networks, however maintaining complexity at a reasonable level
  • Treatment access for larger population groups, Biosimilars, and Cost pressure on Biologic

18.35

CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

18.45

NETWORKING DRINKS RECEPTION

DAY TWO

08.30 – 08.35

CHAIRPERSON’S OPENING REMARKS FOR DAY TWO AND SUMMARY OF DAY ONE

08.35 – 09.10

Project Acceleration and Breakthrough Designation for Biologics: Effect on early and late stage CMC development

  • Strategies for streamlining CMC packages
  • Minimizing changes during development
  • Front-loading versus fast to IND
  • Accelerating/Compressing late stage development
  • Effect of flexible plants, disposables and continuous processing

09.10 – 09.45

Operating a multiproduct facility: the critical role of process simulation

  • Modeling a long range production plan
  • Measuring facility utilization
  • Identifying equipment bottlenecks
  • Identifying resource constraints
  • How process variability effects throughput
  • Integrating real time facility analytics

Downstream Processing

09.50 – 10.25
Downstream Purification and Automation Strategies for Microbial Expressed Proteins

  • Microbial expression
  • Downstream process development
  • High Throughput Development
  • Automation and parallelization
  • Interdependencies between upstream and downstream development

Upstream Processing

09.50 – 10.25
Continuous Upstream platform versus Fed Batch platform: Development and commercial production perspectives

  • Most of the commercial large molecules products are produced using a continuous Upstream platform and
    new NME’s at are developed on a Fed Batch Platform
  • How we view the benefits of a continuous Upstream platform and why change to a Fed Batch Platform
  • A unique perspective of a large pharmaceutical company who actively uses both platforms

10.25 – 10.45

COFFEE BREAK & MEETINGS

10.45 – 12.15

One to One Meetings

  • Downstream/Upstream Process Technology Platforms
  • Specialised cell culture media
  • Single-use & Disposable Technologies
  • Smart Manufacturing Technologies – Technology Transfer
  • Facility Management & Integration
  • Capacity & Facility Design
  • Multi product facilities
  • Energy & Operational Efficiency
  • Lean/Transformational Change – Operational Excellence
  • Continuous Improvement / Manufacturing Processing
  • PAT & MES, Automation and Process Control Excellence
  • QbD
  • Quality Assurance & Quality Systems
  • Regulation – Rapid Release Testing
  • Finance / Inward & Foreign Investment
  • cGMP – Contract, External Manufacturing Services
  • Biogenerics/Biobetters
  • Personalised Medicines
  • Cell & Gene Therapy
  • Fill and finish
  • Cold chain
  • Microbial Process Development and Production

10.45 – 11.15
End-to-End Processing of Biopharmaceuticals – Options for scale-up and/or scale-out strategies

  • End-to-end processing may embrace batch, continuous or hybrid technologies
  • Single-use technologies enable proven scale-up and then scale-out
  • Significant productivity improvements may be achieved through effective process design
  • Using a toolbox approach to develop and scale-up a process enables productivity improvements across a broad range of advanced biologics modalities

11.15 – 11.45

Chromassette®: A Stackable Chromatography Cassette Enabling Next-Generation Bioprocessing

  • A stackable, single-use and pre-packed chromatography cassette with a supported bed (Chromassette®) is a novel product concept in DSP, addressing the current key challenges in manufacturing.
  • Chromassette combines the separation capabilities of chromatography resins with the convenience of a pre-packed, modular cassette as shown in a range of application examples.

11.45 – 12.15
A new generation of Enterprise Systems

  • Fully integrated system
  • Lean validation programs
  • Paperless validation
  • Fully Automated
  • Validation to decommissioning
  • Validation through frameworks
  • Risk assessments

12.15 – 13.05

NETWORKING LUNCH

Downstream Processing

Upstream Processing

13.05 – 13.40
Process development and manufacturing of Antibody Drug Conjugates

  • Process development and challenges for different ADC platforms
  • Strategies for ADC manufacturing
  • Control of product heterogeneity
  • Improvement for future processes

13.05 – 13.40

Integrated Microbial Process Development: Overcoming Developability Challenges

  • Novel biotherapeutic formats pose unique development challenges. Strategies for successful development need to holistically consider all aspects of biopharmaceutical processes such as expression strategies, novel unit operations, automated high-throughput process development, as well as scale-up and transfer from bench to large-scale manufacturing. We present our holistic approach based on a HTPD toolbox to lever the complexity of manufacturing development for non-platform biotherapeutics. Integration of the whole process is also discussed

13.45 – 14.20

Implementation and validation of a single-use mixing system for virus inactivation with solvent / detergent

  • Virus inactivation by solvent Detergent treatment
  • Single Use System
  • Scale-down model for S/D Virus inactivation
  • Steps of the validation (temperature mapping ; Homogeneity study; …)
  • Impact of the EU Reach regulatory authority on S/D IV processes

13.45 – 14.20

Using SPOT™ and SLIM™ technologies and upstream process modulation to reduce cost of goods of manufacturing

  • Increase specific productivity using SPOT™
  • Increase specific productivity and biosimilar product quality using upstream process modulation
  • Reduce process hardware limitations using SLIM™ technology
  • Reducing cost of goods of manufacturing

Validation/Next Gen Technologies

Biosimilar Development

14.25 – 15.00
Digitising the entire Validation Life Cycle: a productivity leap

  • Traditional paper/hybrid manual validation processes are not efficient, not cost effective, not scalable and with high risks
  • Digital and paperless has become a strategic focus, driven by data integrity concerns and compliance risks
  • > 60% of global Pharma/ Biotech companies are actively looking to digitize the entire Validation Lifecyle
  • Learn first-hand experienced how a leading global Biotech considered, evaluated, implemented and scaled its eVal solution across its entire organisation
  • With detailed results, ROI and considerable cost & productivity savings

14.25 – 15.00

Biosimilars – Differentiation as a success factor

  • Regulators Perspective
  • Biosimilar Landscape
  • Differentiators for success:
    • Manufacturing considerations
    • Technical Development Considerations
    • Interchangeability
    • Portfolio Selection

15.05 – 15.40
Next generation manufacturing for expanding portfolio of biologics

  • Hybrid Model
  • Modular and single-use technologies
  • Flexible fed-batch cell culture
  • High-performance purification
  • Single pass TFF (SPTFF)

15.05 – 15.40

Challenges in developing a biosimilar monoclonal antibody

  • To reach biosimilarity is a technical challenge
  • Biosimilars stimulate innovation
  • Biosimilars push for a decrease in costs
  • Biosimilars push for an increase in quality

15.40 – 15.55

COFFEE BREAK

15.30 – 16.00

Open Panel Discussion: With next gen manufacturing technologies and processes and strategies emerging what gains are being realised for profitability, productivity and quality in future facilities?

  • Assessing the benefits and drawbacks of the latest manufacturing technology trends
  • How Single-use equipment can help achieve performance improvements, both for downstream purification and for manufacturing productivity overall
  • Process and Product Considerations for Flexible Manufacturing
  • How Process Technology Platforms can be used to Optimize areas and parameters in upstream processing and automation opportunities to improve productivity and quality
  • Process intensification strategies in USP and DSP shortening process time

16.30

CHAIRPERSON’S CLOSING REMARKS

16.35

CLOSE

Please note: Agenda and speakers are subject to change.