DAY ONE

07.45 – 08.30

Registration

08.30 – 08.40

Welcome & Chairman’s Opening Remarks for Day One

08.40 – 09.10

Technology Innovations to Expedite Global Biologics Development

  • State-of-the-art technology platforms have been established to expedite global biologics development from discovery to commercialization.
  • Technology innovations will be highlighted for improving development efficiencies and reducing timelines from DNA to IND from a typical duration of 18 months to 7-9 months.

Downstream Processing

Upstream Processing

Chaired by Ravali Raju Principal Scientist, Pfizer

09.15 – 09.50

Pushing the continuous boundary beyond capture for implementation in clinical and commercial processes for portfolio projects

  • An Integrated Bioprocess for Continuous Processing at Late Stage, and Commercial
  • Opportunities for Facility and Process Intensification Beyond Perfusion Production and Continuous Capture
  • Different hand-shake scenarios between upstream and downstream operational modes to handle high titers and / or high harvest volumes
  • Continuous Virus Inactivation

09.50 – 10.25

Downstream FIH Process Development for Non-Platform Molecules

  • FIH platform downstream process to fit F2FIH timeline
  • Key challenges for FIH drug substance process development
  • Downstream process development on non-platform molecules
  • Case study
  • Moving forward

09.15 – 09.50

Leveraging High Throughput Process Development for Microbial Systems

  • A variety of strategies for leveraging HTPD
  • Deep Exploration of Experimental Space
  • Rapid Process Characterization
  • Interfacing with Tech Transfer and Manufacturing

09.50 – 10.25

Single-phase simulations were performed on BI Fremont bioreactors and media mixing vessels at different scales to estimate power number at different agitation speeds (P/V)

  • Consistent power number in the turbulent regime was demonstrated
  • Scale-down models were developed and verified through experimental and CFD results.
  • The CFD power numbers have been implemented at BIFI to calculate P/V in order to provide more accurate prediction for scale-up and transfer for BIFI bioprocesses
  • 10.25 – 11.10

    COFFEE BREAK & MEETINGS

    11.10 – 11.40

    Late stage cell culture and leveraging platform knowledge

    • In phase III cell culture, scientists must consider ways to optimize cell-culture conditions while maintaining productivity, quality and consistency
    • In addition to optimization, one must consider how to maintain these attributes when scaling-up, scaling-down and in tech transfer
    • In this presentation, we will outline the hurdles scientists may face in late stage cell culture and how automation platforms can help navigate these challenges

    11.40 – 12.40

    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

    11.40 – 12.10
    The Evolution of Bioprocess Filtration Single Use Automation: From the Laboratory Bench to the Final Package

    • Why automating a single use bioprocess leads to increased process efficiency and reduces risks.
    • Overview of Parker Hannifin-the worlds leading motion and control company- and our offering in single use automation for bioprocessing applications.
    • How small-scale automation can be used to ensure scale up accuracy and filter performance at cGMP level.
    • The Parker SciLog FD- Automating bulk filtration and dispensing applications. The strategic benefits of automating this process.
    • Parker SciLog Automated NFF Systems – optimise, control and simplify NFF processes.

    12.10 – 12.40
    Fibro chromatography: Ultrafast purification platform addressing mAb purification bottlenecks

    • First truly Single-use Protein A capture chromatography technology
    • Case study data of Pilot scale purification
    • Process scale opportunities available in the near future explored

    12.40 – 13.30

    NETWORKING LUNCH

    Downstream Processing

    Chaired by Natraj Ram, Senior Director, Biologics Process Development, Alkermes

    13.30 – 14.05

    Simulation Tools in Biotechnology

    • Implementation of modelling and simulation tools in biotechnology
    • Mechanistic vs. statistic modelling
    • First steps towards an “Insilico Process Development”
    • Examples of the biotech industry (e.g. Chromatography Modelling)

    Upstream Processing

    Chaired by Ishaan Shandil Senior Engineer,
    Process Engineering and MT External MFG, Bristol-Myers Squibb

    13.30 – 14.05

    Considerations in developing replacement media for legacy media and demonstrating comparable process performance or product quality

    • MVDA
    • Chemically-defined media development
    • Cell culture process development
    • Biologics production

    14.05 – 14.40

    Enabling accelerated downstream process development for diverse protein therapeutics

    • Overview of process development challenges for a diverse product portfolio (mAb, bispecific, ADC, fusion, fragment, etc)
    • Strategies & case studies for accelerating purification development
      • Advancing manufacturing platform and toolbox
      • High throughput process development
      • Leverage platform/prior knowledge
      • Workflow improvement

    14.05 – 14.40

    Novel and Innovative Characterization Methodology to Optimize Scale Up Strategies for Bioreactors

    • Oxygen Transfer Rate
    • Improving the Standard Measuring Method
    • Reactor Scale Up/Down
    • Optimizing Cell Culture Processes

    14.40 – 15.15

    Digitalization from Past to Future – Process Development and Tech Transfer

    • Use of in silico plant model to guide process definition and linkage of process parameters to quality and performance attributes
    • Evolution of predictive model database and use of retrospective data to design prospective studies to enhance predictability
    • Potential to scale-up with data lake
    • Use cases with complex molecules

    14.40 – 15.15

    Building A Strong Upstream Manufacturing Platform: Leveraging Media Selection and Development

    • Introduction demonstrating the importance of establishing a strong upstream platform
    • General strategies to build a platform process transferable to GMP and commercial setting
    • Case study: Media second sourcing to ensure material supply
    • Case study: media development to simplify platform and support different modalities

    15.15 – 16.05

    COFFEE BREAK & MEETINGS

    16.05 – 17.35

    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

    16.05 – 16.35

    A Journey in Continuous Protein A Chromatography

    • Implementation of a continuous protein A capture process for antibody applications embedded in an end-to-end single-use GMP manufacturing process of a multispecific mAb.
    • Moving to a more heterogeneous portfolio of antibodies and fusion proteins, more flexibility and lower expenditure.
    • Demonstrating benefits of single-use equipment and continuous processing

    16.35 – 17.05

    NextGen SUB Applications

    • Evaluations of new single-use bioreactor design providing improved mass transfer and power per volume
    • Utilizing unique drivetrain and vessel geometry.
    • Scalability across multiple vessel sizes, sustaining higher cell densities
    • SUB design including a high turndown ratio, enabling multiple seed train stages to take place in a single vessel increasing operational efficiency and reduces facility footprint.
    • Case example in process intensification

    17.05 – 17.35

    Complete single-use upstream workflow from process development to clinical manufacturing to rapidly advancing biologics programs

    • Single-use high-throughput bioreactor systems greatly increase development capability and efficiency
    • Detailed bioreactor characterization effort enables seamless scale-up and process transfer from high throughput mini-bioreactors to clinical scale at 2,000 L
    • Streamlined workflow leads to rapid and efficient FIH process development
    • Potential acceleration to late stage development and characterization using the same single-use equipment and methodology

    17.40 – 18.15

    Next-generation bio-manufacturing capabilities and state-of-the-art technologies at Amgen Rhode Island

    • Accelerating the transformation of our pipeline to deliver the next generation of medicines for patients and achieving long term competitiveness
    • Increased bulk production through next-generation biomanufacturing platforms incorporating advanced manufacturing technologies, single use, digitalization and material sciences
    • Greater flexibility, speed and efficiency to manufacture multiple medicines simultaneously.
    • Smaller manufacturing footprint offering environmental benefits such as reduced water consumption and energy and lower levels of carbon emissions.

    17.40 – 18.15

    Management of outsourcing network

    • Outsourcing essentials for a successful transfer and commercial launch?
    • Leading outsourcing operations in early to late-stage process development
    • Developing and sustaining internal and external skill set.
    • Sourcing of appropriate external partners
    • Increasing efficiency and performance of the outsourced network

    18.15

    CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE

    18.20

    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

    Plant Design Philosophy and Technology Transfer Strategy

    • Design Basis for a new facility
    • Utilizing Data Management and Digital tools as part of facility design concept
    • Outlining a complex node to node technology transfer
    • Validation strategy to meet an aggressive timeline

    Downstream Processing

    Upstream Processing

    Chaired by Ishaan Shandil Senior Engineer,
    Process Engineering and MT External MFG, Bristol-Myers Squibb

    09.15 – 09.45

    Impurity Control Strategies and Challenges in Impurity Reduction Studies

    • Different impurity control strategies
    • Pro’s and con’s for different strategies
    • Case study: Antifoam reduction study
    • Technical and analytical challenges met in reduction study

    09.15 – 09.45
    Moving from intenstified fed-batch to an integrated continuous process

    • Case study evaluation of a molecule evaluated both in an intensified fed-batch process and in a perfusion integrated with continuous capture process.
    • Perfusion optimization using operational parameters and cell culture media design
    • Delivering a target product quality profile with perfusion in consideration of historical product quality data
    • Residence time distribution characterization in a perfusion process integrated with continuous capture
    • Economics of stainless-steel intensified fed-batch versus a single use integrated continuous format

    09.50 – 10.25
    Fine-Tuning Process Development, Scale-up and GMP Manufacturing of a Novel ADC Technology Platform

    • Overview of Complex Supply Chain Architecture for ADC Manufacturing
    • QbD-based Strategy to Process Validation of Key Process Parameters
    • Process Scale-up Case Studies
    • Brief clinical update Mersana’s Dolaflexin ADC XMT-1536

    09.50 – 10.25

    Upstream Process Modelling: From Early Stage to Late Stage

    • Strategy to integrate modeling during process development. What kind of Model could be used to accelerate process development and when?
    • Case studies on the application of modelling and statistics: media optimization, process development (fed-batch and perfusion)
    • Decision making tool: what should be required to help select the best process for the right molecule?
    • Limits of modelling for upstream process development and future direction

    10.25 – 10.50

    COFFEE BREAK & MEETINGS

    10.50 – 12.20

    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

    10.50 – 11.20
    High Productivity Harvest- Intensify and displace clarification in Fed Batch cell culture

    • How can I gain from process intensification with the least effort?
    • Should I retrofit my facility to become continuous or not?
    • Is it possible to introduce intensification changes in late clinical or post commercial phases?

    11.20 – 11.50
    Improving single use bioreactor design and process development

    • Improve performance and control when operating under these special conditions
    • Impacts of enhanced energy transfer-Implementing bottom heat exchange, alternate impeller positions, and
      considering agitation dissipation rates
    • How new technology improves equipment utilisation, scheduling efficiency, inventory logistics, and reactor harvest consistency?

    11.50 – 12.20
    Challenges during the Development of a High Cell Density (HCD) Continuous Upstream Process and Evaluation of an Ambr15 Perfusion-Mimic model

    • Impact of the quality and quantity of cryopreserved cells
    • Development of media able to support high cell density cultures
    • Availability of rapid analytical tools which are capable to measure CQAs at small harvest quantities
    • Micro control of a continuous cell culture process
    • Minor equipment failure leads to serious impact on performance
    • Challenges and importance of PAT during small scale runs

    12.20 – 13.10

    NETWORKING LUNCH

    Process Development

    Chaired by Natraj Ram, Senior Director, Biologics Process Development, Alkermes

    Upstream Processing

    Chaired by Ravali Raju, Principal Scientist, Pfizer

    13.10 – 13.45

    Streamline Downstream Process Characterization to Accelerate Late Stage Development for Process Performance Qualification

    • Process characterization (PC), a lengthy process required for performance qualification
    • QbD Approach for process characterization study design
    • Various study approaches and statistical data analysis tools evaluated to shorten timeline
    • Streamline PC methodology for mAb platform to accelerate late stage development
    • A mAb case study presented, challenges and bottle necks identified, future solutions provided with lesson learned

    13.10 – 13.45

    The Evolution of a Next Generation, High-Intensity Manufacturing Process – A Pfizer Update

    • The evolution of a Boehringer Ingelheim, Pfizer collaboration design of an intensified, next generation manufacturing process
    • The evolution from a proof of concept system through GMP design considerations is a significant challenge
    • New integrated skid (iSKID) assimilates, prototype system increases process efficiency
    • They system integrated iSKID is capable of 24-hour, unmanned operation, delivering superior daily productivity to traditional batch processing in a low bioburden environment
    • Learnings from the prototype system play a significant role in the design of a GMP bioprocess manufacturing system

    13.50 – 14.25

    Parallelized DSP steps with a single-skid at pilot-scale: manufacturing strategies, buffer platforms and equipment integration

    • We performed advanced trials of a pilot-scale equipment allowing several DSP steps to be performed at the same time
    • The strategy employed was: multi-column capture step, followed by an automated viral inactivation step, followed by a depth filtration step paired with an ion exchange chromatography step.
    • We also tested several features of the equipment to apply different buffer platform strategies: 1X buffers, in-line dilution and an advanced inline buffer conditioning

    13.50 – 14.25
    Post-approval Lifecycle Management Strategies for Biopharmaceuticals

    • Post-approval CMC changes for biopharmaceuticals: what are the drivers, where do changes typically take place, what are the main obstacles & regulatory expectations
    • CMC changes: a shift of paradigm demanding greater flexibility
    • CMC Lifecycle Management: the risk & cost of getting it wrong
    • Strategies and tools to optimize the post-approval Lifecycle Management of Biologics
    • Case studies and FAQs

    14.25 – 15.00

    How to exit a commercial roller bottle process and fix the quality attributes for a complex protein. A joined Up – and Downstream Approach.

    • 2nd Gen Process Development (from roller bottles into bioreactors) for a complex non mab like protein
    • Significant Yield Increase and Cost Reduction
    • Joined Up- and Downstream approach to keep Quality Attributes within commercial range
    • Challenges during Upscale and Lessons Learned

    14.25 – 15.00
    End-to-End Engagement and Tools to Ensure Successful Tech Transfers

    • Discuss Amgen’s comprehensive approach to ensure right-first-time tech transfer
    • End to end tech transfer process evaluating raw materials, process design and control, facility fit, PPQ/Process Validation, and continued process verification
    • Modeling and tools to reduce cost and risks while accelerating tech transfer
    • Digital transformation shifting document driven to data driven tech transfer

    15.00 – 15.20

    COFFEE BREAK

    15.20 – 15.55

    Process intensification strategies for modern bioprocessing facilities:

    • Approaches to eliminate manual steps in USP and to establish high cell density processes
    • Strategies to combine DSP unit operations
    • Intelligent buffer management solutions
    • Digitization and PAT to enhance process control

    15.55

    CHAIRPERSON’S CLOSING REMARKS

    16.00

    CLOSE

    Please Note: Workshop Agenda and Speakers can be subject to change