Agenda
DAY ONE
07.35 – 08.20
Registration
08.20 – 08.30
Welcome & Chairman’s Opening Remarks for Day One
08.30 – 09.00
Platform fit for the non-platform molecules: simultaneous innovation of platform and process
- Merck has a drug substance manufacturing platform for biologics with state-of-the-art facilities that prioritize green and sustainable practices.
- Technological advances are integrated to manage the complexity of next-generation biologics.
- Platform fit for the non-platform molecules are discussed in case studies.
09.00 – 09.30
Implementing Filtration Technologies for Both Upstream and Downstream Unit Operations in Continuous Biomanufacturing
- Filtration plays critical roles in upstream and downstream continuous processing and presents unique challenges compared to traditional batch manufacturing.
- Perfusion cell culture requires highly optimized filtration operations to ensure a high degree of product recovery while maintaining high throughput and cell viability.
- Microza™ TFF filters demonstrate excellent performance for perfusion cell culture operations and provide the range of scales needed for commercial manufacturing.
- Continuous virus filtration (VF) is performed at a much lower flux and much higher throughput than most batch operations, presenting challenges for both filter fouling and viral clearance.
- Planova™ filters can provide excellent continuous VF performance but understanding specific characteristics of mAb products may be critical to ensure success.
Downstream Development
09.30 – 10.00
State-of-the-art downstream process development and manufacturing
- High-throughput process parameter screening to speed up development timelines.
- Downstream process intensification combined with plant modelling to optimize facility utilization.
- CFD and mechanistic modelling to support scale-up from small scale to final commercial scale.
- Alignment of Next Generation Downstream Process with Sustainability goals.
Upstream Sciences
09.30 – 10.00
Transforming traditional cell culture process development with insilico solutions
- Establishing a generic insilico model for cell culture processes.
- The impact of generic models on cell culture productivity and quality over multiple programs.
- Can Insilico modelling significantly improve process development over traditional approaches?
- What gains can we achieve by applying insilico modelling to early or late-stage programs?
10.00 – 10.30
Primary recovery and capture step Intensification for a high cell density upstream process
- High cell density increase product titres and reduce costs but pose challenges in downstream purification such as reduced filtration capacity, elevated soluble impurities in primary recovery, and capture step.
- Continuous discharge, single-use centrifugation followed by a polishing filtration identified as the preferred method for clarifying high cell density cultures.
- The new primary separation process was compared to conventional two-stage depth filtration, showing similar clarification efficiency but with a smaller filter area, improving sustainability through reduced water use and depth filter waste.
- An intensified Protein A capture step with high-binding capacity resin, operated at reduced bed height increased the productivity, maintained product quality, and reduced host cell proteins, addressing the challenges of high titres and elevated impurities.
10.00 – 10.30
Next-Generation Facility, a multiproduct facility using Generic Automation Recipes: Strategy, Challenges and Impact on Technology Transfers
- NGM manufacturing and Next Generation Data Systems
- From Product Specific Recipes to Multiproduct Generic Recipes
- Impact on Tech Transfers
- Implications for Subject Matter Experts and development of skillsets
10.30 – 11.20
COFFEE BREAK & MEETINGS
11.20 – 12.00
Roundtable Discussions
For 6 to 10 participants (per roundtable) to discuss and debate on a topic of their choice
1. Addressing Upstream Bioprocessing Complications
2. Optimizing Cell Line Development for Next Generation Biologics
3. Downstream Process Development Strategies for Effective Bioprocesses
4. How MSAT Drives Efficient Tech Transfer. Innovative Solutions For Bioprocessing Challenges
5. Delivering Fast, Flexible, Reliable Manufacturing Leveraging Automation and Digital Technologies
6. Next Generation Bioprocess Facility Design
7. Latest trends in Integrated Continuous Bioprocessing
8. Challenges in Outsourcing CMC development
12.00 – 13.30 One to One Meetings & Investment Areas
- Downstream/Upstream Process Technology Platforms
- Biopharma 4.0
- Digitalization
- Specialised cell culture media
- Single-use & Disposable Technologies
- Separation and Purification Technology
- Virus Filtration Processes
- Smart Manufacturing Technologies – Tech. Transfer
- Facility Management & Integration
- Biopharma & Modular Biosafety Technology
- Capacity & Facility Design
- Multi product facilities
- Fluid Management Systems
- Lean/Operational Excellence
- Continuous Improvement
- PAT & MES, Automation and Process Control Excellence
- QbD, Quality Assurance & Quality Systems
- Validation Process/Life cycle Management systems
- Regulation – Rapid Release Testing
- cGMP – Contract, External Manufacturing Services
- Biogenerics/Biobetters
- Personalised Medicines
- Cell & Gene Therapy
- Fill and finish
- Microbial Process Development and Production
- Osmolality testing
- Bioprocessing Osmometers
12.00 – 12.30
Introducing the next cycle of affinity resin innovation
- The bioprocessing industry is continually challenged to increase productivity while keeping the cost of goods down when developing the next generation of
therapeutics. One key aspect of the downstream purification process is the capture step, which relies upon protein A chromatography resins. - Purolite, an Ecolab company, will present its next-generation high-capacity protein A resin that demonstrates improved stability with low ligand leakage.
The resin aims to increase productivity and cost reductions. Building on the success of Praesto™ Jetted A50 HipH, this protein A continues to address aggregation
and impurity clearance through a wider pH elution window.
12.30 – 13.00
Implementing PUPSIT Using Single-Use Systems for Final Fill
- For manufacturers who cannot terminally sterilize their product in its final container and require sterile filtration, the revised Annex 1 means that Pre-Use Post-Sterilization Integrity Testing (PUPSIT) has become a default requirement.
- This presentation is intended to explore the current thinking regarding the implementation and integration of PUPSIT for organizations utilizing Single-Use Systems (SUS) in final fill operations.
13.00 – 13.30
New Bioprocess Strategy with Fiber Chromatographic Clarification Platform from Discovery to Manufacturing
- We will explore how novel clarification technology, based on advanced synthetic fibrous chromatography materials, will enable new bioprocess strategies to address critical challenges in process simplification and intensification.
- We will illustrate how this platform can offer seamless implementation of chromatographic clarification from discovery to clinical and commercial manufacturing, providing consistent and high-quality clarified fluid and enhancing commercialization productivity.
13.30 – 14.20
NETWORKING LUNCH
Downstream Development
14.20 – 14.50
The minimum requirement on PAT’s success for industrial implementation: The simultaneous prediction of multiple relevant Product Quality Attributes in real-time
- Raman-based PAT
- Multi-attribute measurement
- In-line quality monitoring
- Machine learning methods
Upstream Sciences
14.20 – 14.50
Powering into a new era of complex molecules – A stepwise approach towards process validation
In this presentation, we will highlight key upstream approaches taken towards enabling the characterisation of non-standard and platform manufacturing processes and evolution of our approach towards BLA filing.
- Outlining the shift in manufacturing requirements due to emergence of complex molecule therapeutics
- Highlighting key challenges faced with demonstrating robustness of upstream manufacturing process prior to BLA with emergence of complex molecules
- Providing an overview of the fundamental approaches taken to adapt to an evolving market of complex therapeutics
14.50 – 15.20
Novel PAT and data science tools in inclusion body processing
- Spectroscopic tools to monitor IB processes
- Data driven models for IB processing
- Process understanding
- Digitalization
14.50 – 15.20
Process Transfer to Commercial Facilities: A Path Filled with Challenges and Requirements
- Regulatory guidelines and in-house requirements
- Identifying process requirements – Risk evaluation and Gap Analysis
- Incorporating Scale Up factors during the Process Transfer
- Implementing new technologies – challenges & requirements
- Insights from a Case Study
15.20 – 15.55
Next Generation Manufacturing and Continuous Bioprocessing: application of rapid bioburden testing
- In this work we focus on the evaluation and testing of a rapid bioburden technology and
its implementation for Intensified and continuous bioprocessing (ICB) microbial control. - This technology allows detect contamination in hours instead of several days – a limitation
of compendial methods. - The speed of detection is crucial to identify contamination and still have time to decide
on material diversion for a continuous process. - In collaboration with NIIMBL colleagues, the strategy on how to use early detection of
bioburden contamination, in a few ICB locations, informs how GMP facilities and their Quality
Management System will need to include new mitigation strategies for product diversion and
consequently batch release. - A case-study developed at AstraZeneca will be presented, where sampling strategy and
real-time data analysis was crucial to inform bioburden levels for all process intermediates
throughout the run.
15.55 – 16.45
COFFEE BREAK & MEETINGS
16.45 – 18.15 One to One Meetings & Investment Areas
- Downstream/Upstream Process Technology Platforms
- Biopharma 4.0
- Digitalization
- Specialised cell culture media
- Single-use & Disposable Technologies
- Separation and Purification Technology
- Virus Filtration Processes
- Smart Manufacturing Technologies – Technology Transfer
- Facility Management & Integration
- Biopharma & Modular Biosafety Technology
- Capacity & Facility Design
- Multi product facilities
- Fluid Management Systems
- Lean/Transformational Change – Operational Excellence
- Continuous Improvement / Manufacturing Processing
- PAT & MES, Automation and Process Control Excellence
- QbD
- Quality Assurance & Quality Systems
- Validation Process/Life cycle Management systems
- Regulation – Rapid Release Testing
- cGMP – Contract, External Manufacturing Services
- Biogenerics/Biobetters
- Personalised Medicines
- Cell & Gene Therapy
- Fill and finish
- Microbial Process Development and Production
- Osmolality testing
- Bioprocessing Osmometers
16.45 – 17.15
Amsphere A+: the new Protein-A affinity resin with high DBC and outstanding 1M NaOH stability
- Protein A chromatography is the most common form of affinity chromatography used in the biomanufacturing of monoclonal antibodies and there are many commercially available PrA resins on the market.
- In 2016, JSR launched Amsphere A3, which gained tremendous momentum in being implemented in >150 clinical and commercial purification processes. The new Amsphere A+ further leverages the great science behind JSR’s PrA-resins and provides even better DBC, caustic stability and pressure-flow performance compared to A3.
- A look on the development journey of and the science behind Amsphere A+ and compare the characteristics and performance of it with other established PrA resins.
17.15 – 17.45
Double the yield of perfusion processes: Process intensification & simplification with Vibro® Membrane Filtration (VMF)
- VMF – Revealing new opportunities for upstream & downstream processes
- Novel cell retention device – Higher cell density, less membrane fouling
- Eliminate process steps such as centrifugation, high speed separator
- Sustainable development and production – 90% reduced energy consumption
17.45 – 18.15
The Quest for the Golden Batch in BioPharma 4.0
- Batch Release Software- How to Capture Data Directly from Batch Engines
- How to gain real-time visibility into batch status and enable faster decision making
- Optimize Yield, Quality, Efficiency and Revenue with the latest Batch historian Software
- Reduce Process Variability and Improve Product Consistency and Quality Control
18.15 – 18.50
JJP-1212 as example for the “SMART GOOSE” story
Autoantigen-specific IgA autoantibodies closely correlate with symptoms severity in a subgroup of patients in multiple autoimmune diseases. Beyond the value of these IgA autoantibodies as biomarkers, the presence of excessive IgA/autoantigen immune complexes results in continuous CD89 (Fc?RI)-mediated activation of myeloid cells, leading to severe tissue damage. Activation of myeloid cells – especially of neutrophils – is a highly underappreciated and untargeted hallmark of autoimmune diseases. Enabling a personalized medicine approach, high autoantigen-specific IgA serum levels will serve as companion diagnostic to stratify patients for personalized treatment with our antagonist humanized anti-CD89 antibody (JJP-1212). Interfering with the IgA/CD89 axis by JJP-1212, resolves IgA/autoantigen-induced inflammation and subsequent tissue damage in a variety of autoimmune diseases.
18.50
CHAIRPERSON’S CLOSING REMARKS AND END OF DAY ONE
18.55
Networking drinks reception
DAY TWO
08.15 – 08.20
CHAIRPERSON’S OPENING REMARKS FOR DAY TWO AND SUMMARY OF DAY ONE
08.20 – 08.50
Arenavirus Platform designed for acceleration of clinical development
- Standardized manufacturing platform across vectors reduces cycle times and costs
- FDA endorsed Drug Master File for Arenavirus reduces regulatory risks
- Agreed development stage driven release panel accelerates development of new vectors
- Seamless scale-up from 200L to 500L and to 1000L enables global supply at reasonable costs
- Liquid and lyophilized formulations create optionality and allows for global supply of affordable medications
08.50 – 09.20
Development of an effective cell culture media supporting the entire transfection process
- Adeno-associated virus (AAV) has become a prominent vector for treating life-threatening genetic diseases, increasing the demand for high levels of infectious AAV particles. To support this growing industry, optimizing media and processes is crucial for achieving high AAV titers
- To maximize AAV titers across multiple HEK293 cell lines medium development was carried out with three HEK293 cell lines, each having different growth rates.
- Additionally, optimized transfection parameters and smaller DoE designed transfection parameters were applied to cell cultures grown in media from various vendors, requiring different transfection conditions to achieve high AAV titers.
- The impact of a post-transfection feed regime on titer was also evaluated.
Bioprocess Innovation
09.25 – 09.55
Sustainability in Biopharma: From Challenge to Opportunity
- Overview of Sustainability in Biopharma
- Key challenges in of Sustainability and Eco Assessment in Biopharma
- Eco-Design as cornerstone for Greener Manufacturing processes
- Case Studies and Examples to foster Greener Science and Green Culture in Biopharma
Digitalization
09.25 – 09.55
Vision and Value of Digital Twin for Drug Substance Processes
- Intro to Digital Twin (DT) concept and added value compared to previous (current) paradigm
- Presentation of GSK vision for DT
- High level current state at GSK Vaccines
- Main challenges to overcome.
09.55 – 10.25
Development of a 10 g/L process for a difficult-to-express multi-specific antibody format using a holistic process development approach
- The presentation provides an example on how to overcome expression limitations of bi- and multispecific antibodies in a holistic approach, using tools of molecular biology, cell line development, upstream process optimization and process intensification.
- The combination of molecular constructs described in this article allows very high expression levels, which is highly useful for difficult-to-express proteins
- Process allowing titers > 10 g/L (product) for bi- and multi-specific antibody formats
09.55 – 10.25
Digital Strategy In Action: Building Strong Foundations
- Foundations for a successful data & digital strategy
- Data architecture in commercial biotech manufacturing
- The benefits of real-time monitoring and predictive analytics
- Examples of successful implementations and their impact on process efficiency and reliability
10.25 – 11.00
COFFEE BREAK & MEETINGS
11.00 – 12.00
Roundtable Discussions
For 6 to 10 participants (per roundtable) to discuss and debate on a topic of their choice
1. Addressing Upstream Bioprocessing Complications
2. Optimizing Cell Line Development for Next Generation Biologics
3. Downstream Process Development Strategies for Effective Bioprocesses
4. How MSAT Drives Efficient Tech Transfer. Innovative Solutions For Bioprocessing Challenges
5. Delivering Fast, Flexible, Reliable Manufacturing Leveraging Automation and Digital Technologies
6. Next Generation Bioprocess Facility Design
7. Latest trends in Integrated Continuous Bioprocessing
8. Challenges in Outsourcing CMC development
12.00 – 13.30 One to One Meetings & Investment Areas
- Downstream/Upstream Process Technology Platforms
- Biopharma 4.0
- Digitalization
- Specialised cell culture media
- Single-use & Disposable Technologies
- Separation and Purification Technology
- Virus Filtration Processes
- Smart Manufacturing Technologies – Technology Transfer
- Facility Management & Integration
- Biopharma & Modular Biosafety Technology
- Capacity & Facility Design
- Multi product facilities
- Fluid Management Systems
- Lean/Transformational Change – Operational Excellence
- Continuous Improvement / Manufacturing Processing
- PAT & MES, Automation and Process Control Excellence
- QbD
- Quality Assurance & Quality Systems
- Validation Process/Life cycle Management systems
- Regulation – Rapid Release Testing
- cGMP – Contract, External Manufacturing Services
- Biogenerics/Biobetters
- Personalised Medicines
- Cell & Gene Therapy
- Fill and finish
- Microbial Process Development and Production
- Osmolality testing
- Bioprocessing Osmometers
12.00 – 12.30
Sustainability in Biomanufacturing: Leveraging Continuous Processing and Advanced Single-Use Technologies
- Biomanufacturers are being challenged to balance the development of new therapeutic modalities and reducing manufacturing costs while maintaining environmental responsibility.
- Efforts are underway to improve process robustness and efficiency and create more flexible manufacturing facilities.
- Key strategies include adopting single-use technologies, implementing process-intensification and continuous manufacturing strategies, enhancing process analytics, and developing digital capabilities to leverage artificial intelligence (AI) in development and manufacturing.
- Collaborative projects addressing these issues through new chromatographic solutions will be presented.
12.30 – 13.00
Buffer management strategies: how to stay nimble and competitive in biologics manufacturing
- Holistic approach to buffer management, discuss the known and unknown challenges, and consider different options of buffer preparation, weighing the merits of in-house vs. outsourcing.
- Conceptual design scenarios in both existing and new facilities will be shared to assist with the economics and logistics of the buffer journey.
- How the best buffer management approaches come together to deliver significant operational benefits —allowing biologics manufacturers, including CDMOs, to remain nimble and competitive
13.00 – 13.30
Forget about Isolators: High Accuracy for Automated Small Volume Filling
Automated and standardized aliquoting of biopharmaceutical drug substances into single-use bags simplifies the manufacturing process while improving throughput, speed, and filling accuracy. Learn how Single Use Support took pride in developing breakthrough technologies for a customer to improve fluid management processes. The groundbreaking automated filling platform helped eliminate the need for isolators and standardize the aliquoting of small volumes of biopharmaceuticals to meet
- GMP Annex 1 requirements
- Cost-efficiencies in the fluid management process (OPEX/CAPEX)
- Unprecedented filling accuracy and speed
13.30 – 14.20
NETWORKING LUNCH
Process Transfer/Analytical Development
14.20 – 14.50
Harnessing Innovative Strategies using an Advanced Analytical Toolbox to meet demands of Complex Protein Therapeutics
- Developing analytical strategies for CMC support
- Supporting accelerated complex biotherapeutic development
- Building an advanced analytical toolbox
- Case Studies – applying and tailoring toolbox approaches
Bioprocess Innovation
14.20 – 14.50
Debottlenecking of a tangential flow filtration process for high concentration monoclonal antibody formulation
A significant yield reduction with associated flux decay and was experienced while scaling up a mAb process to manufacturing scale due to gel layer build-up during a TFF process execution. In a fast-track approach, the challenges with increased viscosity and yield reduction were mitigated using a model protein/ molecule and changes in process and material re-design.
14.50 – 15.20
Application of Plant and Process Models from Development to Commercial Facility
- Models as digital solution to address process and facility related challenges
- Case studies of applying plant & cost models for e.g., transfer and debottlenecking activities
- Creation and utilization of holistic USM & DSM plant models for manufacturing facilities
- Optimization of model capabilities and integration into workflows
14.50 – 15.20
Elucidating the Influence of Antibody Surface Charge Heterogeneity in Cation-exchange Polishing with High-throughput Techniques and Multiscale Modelling
- Automation and multiscale modelling can be integrated to accelerate purification development and aid in process understanding
- Two mAbs with approximately the same isoelectric point had notably different loading and elution behaviour in cation-exchange chromatography
- These molecules had differences in surface charge density in the antibody CDR region, which was directly tied to the screening outcomes
- Protein surface properties should be considered during development of chromatographic polishing steps, since isoelectric point does not tell the full story
15.20 – 15.40
COFFEE BREAK
15.40 – 16.10
Capabilities of KIWI-Biolab’s robotic ecosystem by orchestration of model-based DoEs and fast in-depth analytics for process development in biopharma
- Solving the challenge: an automated lab which combines all elements of bioprocess development
- Self-driven model-based bioprocess development is possible
- Scalability from high throughput stations to industrial scale is a major issue which can be verified through parameter identification
- FAIR data is not only the key of all autonomous operations be also for integrating collaboration into a HT facility.
16.10
CHAIRPERSON’S CLOSING REMARKS
16.15
CLOSE
Please Note: Workshop Agenda and Speakers can be subject to change