Agenda
DAY ONE
07.45 – 08.30
Registration
08.30 – 08.40
Welcome & Chairman’s Opening Remarks for Day One
08.40 – 09.10
Smart Process Analytics for the End-to-End Batch Manufacturing of Monoclonal Antibodies
For many modern biopharmaceutical processes, manufacturers develop data-driven models using data analytics/machine learning (DA/ML) methods. The challenge is how to select the best methods for a specific dataset to construct the most accurate and reliable model. This article describes the application of smart process data analytics software to industrial end-to-end biomanufacturing datasets for monoclonal antibody production to automate the determination of the best DA/ML tools for model construction and process understanding. The application demonstrates that smart process data analytics software captures product-and process-specific characteristics for two different monoclonal antibody productions. This study provides tools that can be widely applied to biomanufacturing processes for root cause analysis, prediction, and control.
Downstream Processing
09.10 – 09.40
Next generation downstream processing
- High throughput process parameter screening to speed up development timelines
- Downstream process intensification to increase facility utilization
- CFD and mechanistic modelling to support scale-up from small scale to final commercial scale
CMC Development/New Modalities
09.10 – 09.40
Raman spectroscopy to stabilize product quality for continuous upstream processes
- Today’s pharmaceutical industry has a high interest in moving towards continuous biomanufacturing
- Continuous processes based on cell culture perfusion become highly attractive for mAbs
- The bioprocess footprint is reduced by running a smaller bioreactor in steady-state perfusion during weeks/months
- Keeping a process in a steady state despite culture aging demands a tight feedback control system
- This case study shows the power of Raman to stabilize the process
09.40 – 10.10
Insights into Platform Purification Process Evolution
- Using initial capture as an example, look at current landscape of purification options available and how to evaluate
- Consider if non Protein A option(s) may be useful to integrate into a DSP development toolbox
- Making effective use of process and cost models, within DSP development, to support decision making
- Impact of covid pandemic on purification development
09.40 – 10.10
Effective cell culture operations by accurate, non-invasive determination of the critical process parameter pH in Roche`s Drug Substance Network
- Problem statement: Limitations of the current industry standard of sample based offline pH measurement
- Solution: BioTalk 2018 Follow up on offgas based pH determination: how it works
- Manufacturability: Implementation of the offgas based reference method in GMP manufacturing
- Results: Some thoughts on business value
- Take home messages / Discussion starters
10.10 – 11.00
COFFEE BREAK & MEETINGS
11.00 – 11.30
Introducing Planova™ S20N, a Novel Superior Regenerated Cellulose Virus Removal Filter
- Made of superior cuprammonium regenerated cellulose NEW PLANOVA S20N withstands higher operating pressure making it simple for the post-use integrity test.
- Planova S20N shows robust virus removal capability, higher throughput, and stable protein filterability at higher operating pressures over a wider range of solution conditions and molecules (e.g., multi-specific antibodies).
- We will present the characteristics and results of customer-led evaluations and internal studies on Planova S20N filters.
11.30 – 13.00 One to One Meetings & Investment Areas
- Downstream/Upstream Process Technology Platforms
- 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
11.30 – 12.00
Filling the gap between Downstream & Fill-Finish with scalable single-use technologies
- The advantages of bags over bottles for primary packaging
- Eliminate manual processes during substance filling
- Benefits of controlled plate-freezers for your product quality
12.00 – 12.30
Understand Manufacturing Costs, Impact on Yield and Sustainability of Single-use Technologies in Bioprocesses by Modelling
- In this presentation we will examine the impact of process intensification on sustainability and cost saving opportunities and yield improvements through advanced material solutions.
- Advanced material-based technologies offer the ability to intensify processes by enabling faster mass transfer, being able to operate in a broader range of conditions and deal with a diverse range of particle sizes.
- In a case study we will compare advanced single-use technologies with more traditional approaches and show the impact on cost savings and sustainability.
12.30 – 13.00
Waters Bioprocess Walk-Up Solution – let the system work for you!
- Improve process understanding and develop more robust manufacturing processes with a streamlined integrated analytical solution
- Reduce costly delays and eliminate human errors with automated sample preparation and data transfer
- Automate routine product quality and spent media analyses to simplify and accelerate your bioprocess development
13.00 – 13.50
NETWORKING LUNCH
Downstream Processing
13.50 – 14.20
Process Intensification technologies using In-line concentrators for High Titer mAb process
- As mAb titers are increasing, its straining downstream purification manufacturing technologies. One of the issues facing manufacturing is the ever increasing in-process volumes, due to increasing titers.
- A look at comparative evaluation of Single Pass Tangential flow filtration (SPTFF) or In-line product concentrators technologies for the management of in-process volumes for downstream process fit.
- Comparative evaluation of SPTFF technologies on in-process volume controls including process robustness and controlling parameters, product quality impact, manufacturing scalability and implementation
Upstream Processing
13.50 – 14.20
Superior cell culture performance through rational media design
- Continuous improvement of chemically defined media for efficient and robust antibody production of CHO cell lines
- Enhanced media insights from metabolic and in silico methods
- Enabling high titer, high viability process starting from FIH
- Media design and feeding strategy modulation to target productivity and product quality
14.20 – 14.50
Development of Process Analytical Technologies for Downstream Processing in Commercial Biologics Production
- Examples of PAT application in DSP manufacturing process
- Benefits and challenges of inline measurements and controls in GMP production.
14.20 – 14.50
PAT in Upstream Processes – Fantastic as Development Tool and When to Use in Manufacturing
- Examples of PAT tools used in USP development and transfer
- Raman spectroscopy for generic plattform-wide prediction models
- Biocapacitance for precise CSPR control in N-1 perfusion development
- Multidimensional Fluorescence spectroscopy in media preparation
- Online measurement of oxygen uptake rates to support clone selection
- When should PAT move from development to manufacturing
14.50 – 15.20
Realization of automated learning for bioprocess development by integrating robot-driven well-controlled parallel cultures, analytical technologies, and modelling
- Automated laboratories become state of the art. However, to gain a maximum of knowedge from the experiments, implementation of a closed loop learning framework is a key with (i) integrated real-time high-throughput analytics, (ii) proper automated real-time handling of the generated data to control the running experiments. The data should follow the FAIR (Findable Accessible Interoperable Reusable) principles, (iii) Integration of a model-based tool tailored for the small data problem, real-time use of mathematical models that can deal with the low data/complexity ratio that characterizes bioprocess development.
- The KIWI-biolab aims to solve these issues with an integrative and collaborative approach. Analytical technologies are connected with high throughput cultivation systems and with tools for automated documentation and standardization of experimental/computational workflows. AI approaches are adapted to High Throughput Bioprocess Development by the use of mechanistic models in combination with Machine Learning algorithms (hybrid models). The strength and relevance for scalability of this approach is documented by examples from bacterial protein expression projects.
15.20 – 16.10
COFFEE BREAK & MEETINGS
16.10 – 17.10 One to One Meetings & Investment Areas
- Downstream/Upstream Process Technology Platforms
- 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
16.10 – 16.40
Oceo Rover: Automated Hydration System
A significant challenge in bioproduction is to deliver consistent results on time while driving down cost of goods. Transform your bioprocessing with the Oceo Rover automated hydration system. Designed specifically for the hydration of powdered media and buffers, this single-use technology delivers consistent solutions on-demand in less than half the time of usual processes. The system delivers the consistency required for process development and manufacturing scale-up in both upstream and downstream processing, for cell culture and cell and gene therapy applications.
- How preprogrammed recipes deliver consistent results
- How a single unit operation can hydrate and sterilize media and/or buffers
- How prepacked, single-use cartridges can deliver dependable results and step-away reliability
- How a self-contained system improve environmental, health and safety considerations, and eliminate cross-contamination
- How you can access world-class support to help you identify the ideal hydration protocol to optimize
your workflows
16.40 – 17.10
How to Address GMP Annex 1 Requirements Implementing Single-Use Assemblies for Final Fill
- Single-use systems in final filling: effects on efficiency and scalability
- Significant updates in the New Annex 1 and their expectations regarding the use and control of single-use systems
- Annex 1 and final fill single use systems: synergy for greater compliance
- How molded closed single-use systems can reduce the risk of contamination, enhance efficiency, and ensure safety and quality
17.10 – 17.40
Industrialization of biotechnology process with continuous DSP approach
In 2020, demand for development and manufacturing of anti COVID molecule exploded. How did LFB Biomanufacturing succeed in replying to customers in an emergency and supply shortage with DSP continuous solutions.
- Reuse of consumables and single Use chromatography Membranes
- On line Dilution and On line concentration
- Viral clearance studies
- Removal of centrifugation steps by filtration with diatomaceous earth
17.10 – 17.40
Design of Experiments and Modelling for Process Characterisation Studies
- DoE as a tool to optimise process characterisation studies
- Points of attention for the statistical analysis plan
- Acceptance criteria to define CPPs/PARs
- Case study from upstream process development
17.45 – 18.15
Strategy to develop and implement a Downstream Continuous Bioprocess with a fully integrated system for clinical manufacturing scale
- The equipment and automation supporting Next Generation Manufacturing (NGM) for downstream unit operations can be complicated and expensive. In this talk we present an integrated solution for chromatography column operation, viral inactivation with pH control, filtration and in-line dilution
- This solution can lead to significant reductions in facility size, manufacturing costs, and enhanced product quality when compared to the usual batch mode of operation, or the alternative to integrate many different pieces of equipment through a Distributed Control System (DCS) from different vendors
- Details of operation, for the duration of a perfusion run, with bioburden control are explained
- Implementation strategy for GMP manufacturing is presented
18.15 – 18.50
Open Panel Discussion:
Taking Bioprocess Innovation and Applying them Successfully to Other Modalities
- Leveraging expertise in biologics to enable new modalities (gene therapy, cell therapy, etc.)
- What have we learned that can be applied directly?
- What are the unique challenges with viruses and allogeneic cell therapies?
- New technologies that improve biological understanding for manufacturing complex proteins (PAT tools, real time monitoring)
- Have these proven useful? What are the gaps and opportunities?
- Key challenges to get autologous cellular products to as many patients as possible (including solid tumor indications)
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
CSL112 Process Characterization Part II: implementation of a robust process control strategy
- Implementing QbD principles for a plasma-derived biotherapeutic product
- Applying a risk- and science-based approach leading to the identification of process parameters and material attributes potentially impacting quality and performance attributes
- Outcome of process characterization leading to final classification of process parameters and material attributes
- Case studies for the assessment of critical material attributes
- Thorough process understanding leading to a robust process control strategy
08.50 – 09.20
How Data Analytics strengthen daily activities
- Data analytics are usually presented as the data power brought by digital to process understanding or development.
- This technology significantly impacts processes once deployed and pretty often, driven through large projects, very few but experts understand what it would change in their direct environment.
- This presentation will highlight not only the power of the technology, but how it may actually impact your professional life in so many diverse activities, day after day.
Bioprocess Innovation
09.25 – 09.55
Deployment strategies of Digital Twins for accelerating bioprocess life cycling
- Digital transformation is not an option
- Digital Twins are a central part of the digital transformation
- End to end digital twins decrease development efforts by 50%
- Real time deployed digital twins allow for process robustness and optimization
CGT Innovation
09.25 – 09.55
Challenges of a virtual Biotech company in outsourcing CMC development
- CMC development in a small virtual company
- Outsourcing approaches of different CMC tasks
- Early research oriented versus late IMPD oriented development tasks
- CDMO contract generation, project and project management
- How to put needed flexibility into CDMO contracts
- Pitfalls to avoid in contract negotiations
- Pros and Cons of 1-stop shop versus several specialized CDMOs
09.55 – 10.25
Development of a monoclonal antibody using QbD approaches
- Development of a monoclonal antibody using QbD approaches
- Iterative risk assessments to determine focus areas for experiments
- Determination of potential Critical Process Parameters per purification stage
- Design of Experiments during early and late stage to further understand behavior of process parameters
- Use of statistical modeling, including Monte Carlo simulation, to develop the control strategy
- Process performance qualification
09.55 – 10.25
Innovative analytical strategies for addressing common problems for new molecular format CMC development
Complex next generation biological molecules are becoming increasingly prevalent in today’s biopharmaceutical manufacturing landscape. Such molecules present unique challenges, due to their complex structures and heterogeneity, when compared with traditional antibody formats. Through case studies, this presentation will highlight innovative analytical strategies for addressing common problems during product development such as chain assembly, multiple-MoAs and diverse post-translational modifications
10.25 – 10.50
COFFEE BREAK & MEETINGS
10.50 – 11.35
Roundtable Discussions
For 6 to 10 participants (per roundtable) to discuss and debate on a topic of their choice
- Accelerating upstream process development – robust, scalable and reproducible process
- Next Generation Downstream Processing
- Process Intensification, Automation, Data Analytics, and PAT to Enable Continuous Processing and Biopharma 4.0
- Bioprocess Innovation for New Modalities
- Digitalisation and Automation for Acceleration of Bioprocess Development
- Integration of Process Analytical Technologies in Upstream and Downstream
- Best Practices In CMC Development And Effective Technology Transfer
11.35 – 13.05 One to One Meetings & Investment Areas
- Downstream/Upstream Process Technology Platforms
- 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
11.35 – 12.05
Optimizing Harvest and Recovery with Single Step Depth Filtration
- Filter and diatomaceous earth selection
- High throughput screening at 20ml sample size
- Scalability from 0.1L to 2,000L+
- Scale-up for pilot and production
12.05 – 12.35
Advances in Protein A Chromatography Resins
- Jetting technology is a continuous emulsification technology by which all Praesto® chromatography resins are produced.
- This proprietary technology results in resins with a narrow, almost uniform particle size distribution, with excellent mass transfer properties.
- Herein, we present advances which utilize Jetting technology, including process intensification models and a novel Protein A resin designed specifically for elution of Fc-containing molecules at higher pH levels.
12.35 – 13.05
Viral Clearance in Cell & Gene Therapy – What if the Product is a Virus?
- Assuring viral safety in cell and gene therapy (CGT) products poses a unique challenge as the viral vector is a key component of both in vivo and ex vivo gene therapies
- Regulatory authorities expect the viral safety and contamination controls for CGT manufacturing to be assured through the application of a comprehensive program of material sourcing, virus testing at appropriate stages of manufacturing, and removal and/or inactivation of adventitious viruses and helper viruses by the manufacturing process (the ‘three pillars’ approach).
- Material source is key when it comes to viral safety in cell and gene therapy products
- A look at the challenges, considerations, and potential solutions for viral clearance in the field of cell and gene therapy
13.05 – 13.35
Anti-CD89 antibody for personalized treatment of IgA-mediated inflammatory disorders: Autoantigen-specific IgA, a biomarker with strong effector functions
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.
13.35 – 14.25
NETWORKING LUNCH
Bioprocess Innovation
14.25 – 14.55
Late-stage upstream process development: Studies and their timing
- Process characterization
- Justification of process and microbial control
- Hold time studies
- Reprocessing
CMC Development/New Modalities
14.25 – 14.55
Beyond Antibodies – A Transformation
- Transformation from antibody development to developing cell and gene therapies
- Increasing complexity from new modalities
- Reagents to support cell and gene therapy projects
- Case-study: Developing a plasmid DNA process
14.55 – 15.25
Data-driven innovation in biotech manufacturing: advanced analytics to boost performance and commercial value
- Key aspects for successful D&D implementations
- Data & Digital architecture in commercial biotech manufacturing
- Examples from upstream and downstream processing
- Role of “big data” analytics and visualization platforms in effective decision-making:
14.55 – 15.25
From Development Through to Tech Transfer: Bridging latest High Throughput instrumentation with Legacy Instrumentation
- Comparability study using Ambr® 15 integrated with NovaFlexII against legacy instruments across the expected process ranges
- Application of correction factors obtained from a Novaflex II integrated with Ambr® 15 to a Novaflex II integrated with Ambr®250 and final confirmatory study
15.30 – 16.00
Implementation of a highly digitalized process architectures for biopharmaceutical development
- Highly digitalized process architectures for future biopharmaceutical development
- Integrated process and analytics digitalization strategy speeds up PAT development
- Integrated soft sensors and automation can aid minimizing human intervention and increasing process robustness
- Choice of PAT sensor and control strategies affects modelling need
15.30 – 16.00
The right process for the right CMC Needs: Could Upstream Process Toolbox & Process Modelling help to drastically increase DS Productivity
- Platform cell culture processes have several advantages over the case by case redevelopment of processes: seamless transfer of platform knowledge between products, process development acceleration, de-risk scale up and application of validated scale down models.
- Nevertheless specific CMC projects have specific needs, met by integrating and applying specific cell culture changes
- The current strategy and structure of UCB upstream process toolbox including modeling technics and focus on multiple case studies, from clone selection to harvest step.
- Our toolbox methodology combined to process modeling technics provide a better insight into the impact of process parameters on production yields and product quality, thus improving process understanding and control as well as accelerating process development with a more flexible and agile strategy
16.00 – 16.20
COFFEE BREAK
16.20 – 16.50
Accelerating the Development of New Molecular Formats: Speed to Clinic
- Outlining the most pressing challenges of analytical development of novel molecular biologic formats.
- Highlighting how some of these key challenges can be addressed with example case studies.
- Providing an overview of how an end-to-end integrated drug substance and drug product CMC strategy can be used to accelerate the path of a novel molecules to IND.
16.50
CHAIRPERSON’S CLOSING REMARKS
16.55
CLOSE
Please Note: Workshop Agenda and Speakers can be subject to change