Monday 15th September: Pre-Conference Day - ET (Eastern Time, GMT-05:00)
- Introduction
- Objectives and outline of course
- Main development stages and regulatory cadre
- The main streams of activity from cell line to drug product
- The CTD for Regulatory filings. Quality Module – overview of main sections
- The importance of CMC : Quality (and Safety and Efficacy)
- Supply
- The pillars of pharmaceutical development
- Criticality Assessment
- Control strategy & Validation
- QBD Principles
- Most relevant regulatory Guidance and where to find it MH
Quiz
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
This workshop is designed to equip biomanufacturers with the knowledge and tools needed to optimize continuous processing. It will cover:
- Core Principles:
- Automating and controlling continuous processes to reduce costs, improve quality, and enhance efficiency.
- Navigating regulatory hurdles and implementation challenges specific to continuous manufacturing.
- Leveraging process intensification to maximize efficiency and ROI.
- Practical Application:
- Real-world case studies and examples of successful continuous processing implementations.
- Interactive problem-solving sessions to address specific challenges.
- Detailed risk assessment and mitigation strategies.
- Advanced Topics:
- Sustainability considerations within continuous biomanufacturing.
- Future trends and emerging technologies in the field.
- Data management and digitalization strategies for continuous processes.
- Expert Interaction:
- Panel discussions and Q&A sessions with industry experts.
- Networking opportunities to foster connections and collaboration.
The workshop aims to provide a comprehensive understanding of continuous processing, from fundamental principles to advanced applications, enabling attendees to drive innovation and achieve bioprocess excellence.
Key Speakers:
- Shireen Goh, Associate Professor, Singapore University of Technology & Design
- Stefano Menegatti, Associate Professor, North Carolina State University
- David Humphreys, PhD - Executive Director and Head of Antibody and Novel Therapeutics, UCB Pharma
- Yue Liu, PhD - CEO, Ab Studio Inc.
This workshop provides attendees with actionable strategies and expert guidance to navigate the complexities of tech transfer, ensuring a streamlined and successful transition from development to clinical manufacturing.
Understanding the Tech Transfer Process
Gain a clear roadmap for transitioning projects from laboratory research to large-scale clinical manufacturing.
Identify common challenges and best practices to ensure a smooth and efficient transfer.
Optimizing Scale-Up and Clinical Trial Readiness
Learn strategies for scaling up manufacturing processes efficiently.
Discover methods for ensuring reproducibility and overcoming obstacles in clinical trial preparation.
Navigating Regulatory Compliance and Tech Transfer Challenges
Explore key regulatory considerations in tech transfer.
Understand compliance challenges and how to effectively navigate regulatory requirements.
Enhancing Efficiency and Speed in Tech Transfer
Modernize processes with innovative approaches and new technologies.
Implement strategies to reduce development-to-manufacturing time and accelerate the tech transfer timeline.
Leveraging Automation and Cloud-Based Solutions
Explore the integration of automated tech transfer systems across platforms.
Learn how cloud-based solutions can enhance data transfer and collaboration.
Expert Insights and Practical Advice
Gain real-world insights from experienced professionals on avoiding common tech transfer pitfalls.
Participate in interactive discussions, including a regulatory-focused AMA and a panel discussion on overcoming challenges in tech transfer.
- Introduction to Biopharmaceutical Life Cycle.
- Explain what upstream bioprocessing involves: the early stages of production, including cell culture and fermentation.
- Outline the key objectives: generating the desired biological product through cell growth and expression.
- Discuss the selection of cell lines (e.g., CHO cells, microbial cells).
- Introduce bioreactors and their role in providing a controlled environment for cell growth.
- Discuss different types of bioreactors (e.g., stirred-tank, wave, single-use) and their applications.
- Explain the fermentation process and its parameters (e.g., pH, temperature, oxygen levels).
- Explain the importance of culture media in supporting cell growth and productivity.
- Describe the process of scaling up from lab-scale to commercial-scale production.
- Highlight current trends in upstream bioprocessing (e.g., single-use technologies, continuous processing).
- Discuss future directions and innovations in the field.
- Michael Butler - Principal Investigator, Cell Technology, NIBRT
- Explain what downstream bioprocessing involves: the purification and formulation of the biological product after cell culture and fermentation.
- Outline the key objectives: ensuring product purity, quality, and stability.
- Describe the process of harvesting cells or extracellular products from the bioreactor.
- Explain the methods used for cell separation (e.g., centrifugation, filtration).
- Introduce the main purification methods: chromatography, filtration, and precipitation.
- Describe different types of chromatography (e.g., affinity, ion-exchange, size-exclusion) and their applications.
- Explain the principles and applications of ultrafiltration and diafiltration.
- Stefano Menegatti - Associate Professor, North Carolina State University
- Review of the main streams and initial status
- Broad requirements for Tox and for First in Human Studies
- Cell banking
- Other Raw materials
- Drug Substance Process and Manufacture
- Minimum requirements
- Understanding your process :
- Impurities : identity, clearance, control
- First steps towards a control strategy
- Adventitious contamination and Viral Clearance Studies
- Drug formulation and Drug Product Processing
- Analytical package
- Release methods definition and development
- From method performance to method validation
- In Process Controls (else cover under process?)
- Batch data in the submission
- Product Characterisation and Reference standard
- Stability ( DS and DP)
- Forced degradation studies : necessity and importance
- Why is stability important ?
- Different type of stability studies and typical package for PhI
- Shelf life assignment
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
This workshop is designed to equip biomanufacturers with the knowledge and tools needed to optimize continuous processing. It will cover:
- Core Principles:
- Automating and controlling continuous processes to reduce costs, improve quality, and enhance efficiency.
- Navigating regulatory hurdles and implementation challenges specific to continuous manufacturing.
- Leveraging process intensification to maximize efficiency and ROI.
- Practical Application:
- Real-world case studies and examples of successful continuous processing implementations.
- Interactive problem-solving sessions to address specific challenges.
- Detailed risk assessment and mitigation strategies.
- Advanced Topics:
- Sustainability considerations within continuous biomanufacturing.
- Future trends and emerging technologies in the field.
- Data management and digitalization strategies for continuous processes.
- Expert Interaction:
- Panel discussions and Q&A sessions with industry experts.
- Networking opportunities to foster connections and collaboration.
The workshop aims to provide a comprehensive understanding of continuous processing, from fundamental principles to advanced applications, enabling attendees to drive innovation and achieve bioprocess excellence.
Key Speakers:
- Shireen Goh, Associate Professor, Singapore University of Technology & Design
- Stefano Menegatti, Associate Professor, North Carolina State University
- Targeting ligand selection and impact on isotope selection
- Advancements in radiochemistry for improving the safety & efficacy of radiopharmaceuticals
- E.g. use of chelators to attach radioligands to targeting vehicle
- Impacts on manufacturing and quality
- Dealing with variability in radioisotope production
- Implementing robust quality control measures for radioactive materials
- Optimizing manufacturing processes to account for isotope decay
- Strategies for consistent batch-to-batch production
- Considerations for new radioisotopes and indications
- Biodistribution
- Metabolism, Excretions and Decay
- CMC considerations
- Jarrod Longcor - Chief Operating Officer, Cellectar Biosciences
- Novel radiolabelling techniques and their impact on manufacturing
- Microfluidics in radiopharmaceutical production
- Scaling up production for solid tumor therapies
- Site-specific conjugation methods to enhance stability and targeting of radioligand-based therapies
- Enzymatic conjugation
- Click chemistry
This workshop provides attendees with actionable strategies and expert guidance to navigate the complexities of tech transfer, ensuring a streamlined and successful transition from development to clinical manufacturing.
Understanding the Tech Transfer Process
Gain a clear roadmap for transitioning projects from laboratory research to large-scale clinical manufacturing.
Identify common challenges and best practices to ensure a smooth and efficient transfer.
Optimizing Scale-Up and Clinical Trial Readiness
Learn strategies for scaling up manufacturing processes efficiently.
Discover methods for ensuring reproducibility and overcoming obstacles in clinical trial preparation.
Navigating Regulatory Compliance and Tech Transfer Challenges
Explore key regulatory considerations in tech transfer.
Understand compliance challenges and how to effectively navigate regulatory requirements.
Enhancing Efficiency and Speed in Tech Transfer
Modernize processes with innovative approaches and new technologies.
Implement strategies to reduce development-to-manufacturing time and accelerate the tech transfer timeline.
Leveraging Automation and Cloud-Based Solutions
Explore the integration of automated tech transfer systems across platforms.
Learn how cloud-based solutions can enhance data transfer and collaboration.
Expert Insights and Practical Advice
Gain real-world insights from experienced professionals on avoiding common tech transfer pitfalls.
Participate in interactive discussions, including a regulatory-focused AMA and a panel discussion on overcoming challenges in tech transfer.
- Growing importance of digitalization, AI, and machine learning in the biopharma industry.
- Key pillars of digital transformation in biopharma.
Key Areas of Digitalization
- Data Management and Integration (from Development to Manufacturing).
- Automation and Robotics in bioprocess workflows.
- Real-time Monitoring and Advanced Analytics for process optimization.
Applications in Bioprocessing
- Use of digital twins and AI to optimize upstream and downstream unit operations.
- Role of ML/AI-driven tools for Advanced Therapy Medicinal Products (ATMP) manufacturing.
- AI-driven real-time monitoring, predictive maintenance, and anomaly detection in production lines.
- Simulation-based process development for rapid scale-up.
Challenges and Considerations
- Overcoming data silos and ensuring system interoperability.
- Addressing regulatory requirements for AI and digital tools in GMP environments.
- Ensuring data quality, integrity, and security in digitalized workflows.
- Bridging talent gaps and fostering a digitally skilled workforce.
Case Studies
- Real-world examples of digital transformation in bioprocessing.
- Lessons learned from integrating AI-driven tools in ATMP production.
Future Trends and Directions
- Adoption of Industry 4.0 principles in biopharma manufacturing.
- Emerging technologies such as edge computing and IoT for bioprocessing.
- Sustainability and digitalization: How to?
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
- Review of the main streams and initial status
- Broad requirements for Tox and for First in Human Studies
- Cell banking
- Other Raw materials
- Drug Substance Process and Manufacture
- Minimum requirements
- Understanding your process :
- Impurities : identity, clearance, control
- First steps towards a control strategy
- Adventitious contamination and Viral Clearance Studies
- Drug formulation and Drug Product Processing
- Analytical package
- Release methods definition and development
- From method performance to method validation
- In Process Controls (else cover under process?)
- Batch data in the submission
- Product Characterisation and Reference standard
- Stability ( DS and DP)
- Forced degradation studies : necessity and importance
- Why is stability important ?
- Different type of stability studies and typical package for PhI
- Shelf life assignment
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
- Anticipating the needs on the work streams
- Process Understanding and Design
- Technology Transfer
- Dealing with changes and Comparability
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
This workshop is designed to equip biomanufacturers with the knowledge and tools needed to optimize continuous processing. It will cover:
- Core Principles:
- Automating and controlling continuous processes to reduce costs, improve quality, and enhance efficiency.
- Navigating regulatory hurdles and implementation challenges specific to continuous manufacturing.
- Leveraging process intensification to maximize efficiency and ROI.
- Practical Application:
- Real-world case studies and examples of successful continuous processing implementations.
- Interactive problem-solving sessions to address specific challenges.
- Detailed risk assessment and mitigation strategies.
- Advanced Topics:
- Sustainability considerations within continuous biomanufacturing.
- Future trends and emerging technologies in the field.
- Data management and digitalization strategies for continuous processes.
- Expert Interaction:
- Panel discussions and Q&A sessions with industry experts.
- Networking opportunities to foster connections and collaboration.
The workshop aims to provide a comprehensive understanding of continuous processing, from fundamental principles to advanced applications, enabling attendees to drive innovation and achieve bioprocess excellence.
Key Speakers:
- Shireen Goh, Associate Professor, Singapore University of Technology & Design
- Stefano Menegatti, Associate Professor, North Carolina State University
- Optimizing bioconjugation processes for dual-payload ADCs
- E.g. Cysteine conjugation, amino acid incorporation, for payload attachment
- Varying payload incorporation
- Manufacturing considerations for site-specific conjugation
- Analytical method development for complex ADCs
- CMC aspects of regulatory submissions for novel ADCs
- Improving the precision and control of drug attachment in ADC conjugation with site-specific conjugation techniques
- The use of engineered antibodies (e.g. THIOMABs)
- Implementing selenocysteine-containing antibodies
Development of novel conjugation techniques to enhance efficiency and specificity for improved patient outcomes
This workshop provides attendees with actionable strategies and expert guidance to navigate the complexities of tech transfer, ensuring a streamlined and successful transition from development to clinical manufacturing.
Understanding the Tech Transfer Process
Gain a clear roadmap for transitioning projects from laboratory research to large-scale clinical manufacturing.
Identify common challenges and best practices to ensure a smooth and efficient transfer.
Optimizing Scale-Up and Clinical Trial Readiness
Learn strategies for scaling up manufacturing processes efficiently.
Discover methods for ensuring reproducibility and overcoming obstacles in clinical trial preparation.
Navigating Regulatory Compliance and Tech Transfer Challenges
Explore key regulatory considerations in tech transfer.
Understand compliance challenges and how to effectively navigate regulatory requirements.
Enhancing Efficiency and Speed in Tech Transfer
Modernize processes with innovative approaches and new technologies.
Implement strategies to reduce development-to-manufacturing time and accelerate the tech transfer timeline.
Leveraging Automation and Cloud-Based Solutions
Explore the integration of automated tech transfer systems across platforms.
Learn how cloud-based solutions can enhance data transfer and collaboration.
Expert Insights and Practical Advice
Gain real-world insights from experienced professionals on avoiding common tech transfer pitfalls.
Participate in interactive discussions, including a regulatory-focused AMA and a panel discussion on overcoming challenges in tech transfer.
- Understanding emerging therapies: distinctions between cell therapy, gene therapy, etc.
- Therapeutic potential and current clinical landscape of different emerging therapies, unique challenges and opportunities presented.
- Differences and similarities from ‘traditional’ biologics:
- What learnings can we take from traditional modalities to approach novel modalities?
- Understanding the Cell Therapy and Gene Therapy manufacturing processes.
- Best practices when entering/transitioning into the advanced therapy industry.
- Leveraging experiences from your background into industry.
- Strategies and approaches to best utilise available technologies in the development & production of emerging therapies.
- Moving and translating research from academia, to start up, industry, and beyond.
- Understanding the difference between these, how to transition, pros and cons.
- Lessons and experiences from our panellists.
- The evolution of biopharmaceutical modality
- Analytical methods and their purpose in biopharmaceutical development and manufacturing
- Analytical method development and validation
- Product physicochemical characterization - high-performance liquid chromatography (HPLC), capillary electrophoresis (CE), spectroscopy, imaging, and post-translational modification (PTM)
- Product biological assays - cell-based assays (CBA), enzyme-linked immunosorbent assays (ELISA), and potency assays
- Microbiological contaminants - sterility testing, endotoxin testing, and microbial limits testing
- Process impurity testing - host cell DNA, host cell proteins, chromatography ligand
- Role of quality control (QC) and quality assurance (QA) in biopharma
- Case studies and industry examples
- Latest and future advancements in analytical methods and quality assurance
- Gap analyses of the studies available to prepare a Phase 1 submission.
- 4 teams (Analytics, DS, DP, Materials) to cover different parts of case
- 30 – 45 min work in groups : Brief :
- do the existing studies support a Phase 1 file and what are the risks involved?
- Recommendation on eventual additional or superfluous studies
- Map studies / data onto CTD modules (if time)
- 60 min debrief (15 min / group)
- General Conclusions and End of Session
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer, Ph.D. - Scientific Director, Ulysse Consult S.a.r.L
This workshop is designed to equip biomanufacturers with the knowledge and tools needed to optimize continuous processing. It will cover:
- Core Principles:
- Automating and controlling continuous processes to reduce costs, improve quality, and enhance efficiency.
- Navigating regulatory hurdles and implementation challenges specific to continuous manufacturing.
- Leveraging process intensification to maximize efficiency and ROI.
- Practical Application:
- Real-world case studies and examples of successful continuous processing implementations.
- Interactive problem-solving sessions to address specific challenges.
- Detailed risk assessment and mitigation strategies.
- Advanced Topics:
- Sustainability considerations within continuous biomanufacturing.
- Future trends and emerging technologies in the field.
- Data management and digitalization strategies for continuous processes.
- Expert Interaction:
- Panel discussions and Q&A sessions with industry experts.
- Networking opportunities to foster connections and collaboration.
The workshop aims to provide a comprehensive understanding of continuous processing, from fundamental principles to advanced applications, enabling attendees to drive innovation and achieve bioprocess excellence.
Key Speakers:
- Shireen Goh, Associate Professor, Singapore University of Technology & Design
- Stefano Menegatti, Associate Professor, North Carolina State University
- Engin Ayturk - Senior Director, CMC BioConjugation, Process Development & Manufacturing, Exelixis
- Approaching the challenges and considerations when scaling-up ADC production
- Process Optimization
- Quality Control
- Regulatory compliance
- Strategies to incorporate when scaling up conjugation reactions, purification processing, formulation development
- Implementation of robust quality control measures to ensure purity, potency & stability
- Case study on overcoming scale-up challenges
This workshop provides attendees with actionable strategies and expert guidance to navigate the complexities of tech transfer, ensuring a streamlined and successful transition from development to clinical manufacturing.
Understanding the Tech Transfer Process
Gain a clear roadmap for transitioning projects from laboratory research to large-scale clinical manufacturing.
Identify common challenges and best practices to ensure a smooth and efficient transfer.
Optimizing Scale-Up and Clinical Trial Readiness
Learn strategies for scaling up manufacturing processes efficiently.
Discover methods for ensuring reproducibility and overcoming obstacles in clinical trial preparation.
Navigating Regulatory Compliance and Tech Transfer Challenges
Explore key regulatory considerations in tech transfer.
Understand compliance challenges and how to effectively navigate regulatory requirements.
Enhancing Efficiency and Speed in Tech Transfer
Modernize processes with innovative approaches and new technologies.
Implement strategies to reduce development-to-manufacturing time and accelerate the tech transfer timeline.
Leveraging Automation and Cloud-Based Solutions
Explore the integration of automated tech transfer systems across platforms.
Learn how cloud-based solutions can enhance data transfer and collaboration.
Expert Insights and Practical Advice
Gain real-world insights from experienced professionals on avoiding common tech transfer pitfalls.
Participate in interactive discussions, including a regulatory-focused AMA and a panel discussion on overcoming challenges in tech transfer.
- The evolution of biopharmaceutical modality
- Analytical methods and their purpose in biopharmaceutical development and manufacturing
- Analytical method development and validation
- Product physicochemical characterization - high-performance liquid chromatography (HPLC), capillary electrophoresis (CE), spectroscopy, imaging, and post-translational modification (PTM)
- Product biological assays - cell-based assays (CBA), enzyme-linked immunosorbent assays (ELISA), and potency assays
- Microbiological contaminants - sterility testing, endotoxin testing, and microbial limits testing
- Process impurity testing - host cell DNA, host cell proteins, chromatography ligand
- Role of quality control (QC) and quality assurance (QA) in biopharma
- Case studies and industry examples
- Latest and future advancements in analytical methods and quality assurance
Round off your day at BPI School with an interactive and insightful discussion:
- Learnings of the day and a chance to recap:
- Key trends and challenges in biopharmaceutical manufacturing, upstream and downstream.
- The impact of digitalization on the future of biopharma.
- Emerging therapies: Opportunities and obstacles.
- How to utilize and implement analytics tools
- Q&A and interactive discussion with industry experts.
- Bridging the gap between theory and practice in biopharma.
- Michael Butler - Principal Investigator, Cell Technology, NIBRT
- Stefano Menegatti - Associate Professor, North Carolina State University
- Mark Duerkop - Chief Executive Officer, Novasign, Austria