Pre Conference Workshops (12th May 2025)Monday, 12 May 2025 - CET/CEST (Cent Europe Summer, GMT+2)

Spotlight Presentation – Calling all Technology Thought Leaders!

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact us today to learn more: Partners@informaconnectls.com

• Process-Specific Challenges: Each biologic has a unique manufacturing process that may not be amenable to traditional viral inactivation methods (e.g., heat inactivation or low pH).
• Scalability Issues: Viral clearance methods that work at lab scale may not translate effectively to commercial-scale production.
• Multiproduct Facilities: Shared production facilities introduce cross-contamination risks and require highly stringent validation protocols
  
  

This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.

Topics covered are:

The Introduction To The Paradigm of Process and Product Development

Regulatory Background

• Europe and US
• Product specific requirements
• Types of regulations and documents & where they can be found

Commune Technical Document (CTD) & ICH 4M

• Importance for Drug development
• Examples of CTD Requirements for Specific product entities
• Structure of the CTD and where to find the relevant information
• When and how to up-date

Stages in process and product development

• Pre-clinical development stage
• IND / IMPD development stage to start production of material for clinical trials
• IND / IMPD development stage to start production of material for late stage (phase III) clinical trials
• BLA / MMA stage

Requirements / Gates to pass to the next development stage

• Quality requirement of materials (starting materials, reagents and/or raw materials, consumables & auxiliary, primary and secondary packaging) used in the production process
• Definition of the status of Intermediate product, Drug substance, Excipients, Adjuvants (as applicable), others, Drug product
• From TPP, QTPP, CQA, CMA, CPPs to parameters and ranges
• Process flow diagram and control strategy
• Pooling/splitting and processing scale
• Linkage studies between (pCQAs / CQAs & PPs, pCMAs / CMAs & PPs) and identification of CPPs
• Use if small scale models
• Use of surrogate materials
• Scale -up & scale-out considerations
• Transfer requirements
• Process characterization
• Process data trending
• Performance qualification
• Clearance studies and assessments of process and product related impurities
• Leachable & Extractable assessments
• Sterile filter validation and integrity testing
• Adventitious viral risk assessment and safety studies
• Product storage and use conditions
• Compatibility data if applicable
• Process samples for product stability related studies
• Aseptic process simulation validation
• Cleaning and decontamination
• Equipment, including single use ones
• Transport qualification and validation
• GMP certificates
• Analytical Method development

Comparability study requirements

• Extend of studies are stage and change dependent
• When to perform?
• Number of batches to be included
• Studies to be included
• What can be considered as comparable?
• Step by step approach

Process, Material & Analytical Platform

• Why to work with Platforms?
• Definition of Platforms
• Establish PlatformsUse of Platforms and necessary data
• Examples

Quality Risk Management (QRM) and risk based approach

• Importance of QRM
• Fields of application during development
• Tools-box
• How to perform, communicate and document Risk Assessment studies
• Examples

• 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.

• 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.

1. Looking Beyond Antibodies: What are the Applications for Advanced Therapies?

2. The Data Issue: How Can We Utilize and Effectively Analyse Data to Move Towards Fully Automated Processes?

3. Future Thinking: Dreaming Big – Where Do We Want to be in the Next 10 Years?

4. Business Case for Continuous Bioprocessing: What Barriers Exist for Implementing Continuous and Intensified Approaches and Do the Benefits Outweigh this?

This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.

Topics covered are:

The Introduction To The Paradigm of Process and Product Development

Regulatory Background

• Europe and US
• Product specific requirements
• Types of regulations and documents & where they can be found

Commune Technical Document (CTD) & ICH 4M

• Importance for Drug development
• Examples of CTD Requirements for Specific product entities
• Structure of the CTD and where to find the relevant information
• When and how to up-date

Stages in process and product development

• Pre-clinical development stage
• IND / IMPD development stage to start production of material for clinical trials
• IND / IMPD development stage to start production of material for late stage (phase III) clinical trials
• BLA / MMA stage

Requirements / Gates to pass to the next development stage

• Quality requirement of materials (starting materials, reagents and/or raw materials, consumables & auxiliary, primary and secondary packaging) used in the production process
• Definition of the status of Intermediate product, Drug substance, Excipients, Adjuvants (as applicable), others, Drug product
• From TPP, QTPP, CQA, CMA, CPPs to parameters and ranges
• Process flow diagram and control strategy
• Pooling/splitting and processing scale
• Linkage studies between (pCQAs / CQAs & PPs, pCMAs / CMAs & PPs) and identification of CPPs
• Use if small scale models
• Use of surrogate materials
• Scale -up & scale-out considerations
• Transfer requirements
• Process characterization
• Process data trending
• Performance qualification
• Clearance studies and assessments of process and product related impurities
• Leachable & Extractable assessments
• Sterile filter validation and integrity testing
• Adventitious viral risk assessment and safety studies
• Product storage and use conditions
• Compatibility data if applicable
• Process samples for product stability related studies
• Aseptic process simulation validation
• Cleaning and decontamination
• Equipment, including single use ones
• Transport qualification and validation
• GMP certificates
• Analytical Method development

Comparability study requirements

• Extend of studies are stage and change dependent
• When to perform?
• Number of batches to be included
• Studies to be included
• What can be considered as comparable?
• Step by step approach

Process, Material & Analytical Platform

• Why to work with Platforms?
• Definition of Platforms
• Establish PlatformsUse of Platforms and necessary data
• Examples

Quality Risk Management (QRM) and risk based approach

• Importance of QRM
• Fields of application during development
• Tools-box
• How to perform, communicate and document Risk Assessment studies
• Examples

Digitalization in Bioprocessing

• 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?

Spotlight Presentation – Calling all Technology Thought Leaders!

Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.

Contact us today to learn more: Partners@informaconnectls.com

This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.

Topics covered are:

The Introduction To The Paradigm of Process and Product Development

Regulatory Background

• Europe and US
• Product specific requirements
• Types of regulations and documents & where they can be found

Commune Technical Document (CTD) & ICH 4M

• Importance for Drug development
• Examples of CTD Requirements for Specific product entities
• Structure of the CTD and where to find the relevant information
• When and how to up-date

Stages in process and product development

• Pre-clinical development stage
• IND / IMPD development stage to start production of material for clinical trials
• IND / IMPD development stage to start production of material for late stage (phase III) clinical trials
• BLA / MMA stage

Requirements / Gates to pass to the next development stage

• Quality requirement of materials (starting materials, reagents and/or raw materials, consumables & auxiliary, primary and secondary packaging) used in the production process
• Definition of the status of Intermediate product, Drug substance, Excipients, Adjuvants (as applicable), others, Drug product
• From TPP, QTPP, CQA, CMA, CPPs to parameters and ranges
• Process flow diagram and control strategy
• Pooling/splitting and processing scale
• Linkage studies between (pCQAs / CQAs & PPs, pCMAs / CMAs & PPs) and identification of CPPs
• Use if small scale models
• Use of surrogate materials
• Scale -up & scale-out considerations
• Transfer requirements
• Process characterization
• Process data trending
• Performance qualification
• Clearance studies and assessments of process and product related impurities
• Leachable & Extractable assessments
• Sterile filter validation and integrity testing
• Adventitious viral risk assessment and safety studies
• Product storage and use conditions
• Compatibility data if applicable
• Process samples for product stability related studies
• Aseptic process simulation validation
• Cleaning and decontamination
• Equipment, including single use ones
• Transport qualification and validation
• GMP certificates
• Analytical Method development

Comparability study requirements

• Extend of studies are stage and change dependent
• When to perform?
• Number of batches to be included
• Studies to be included
• What can be considered as comparable?
• Step by step approach

Process, Material & Analytical Platform

• Why to work with Platforms?
• Definition of Platforms
• Establish PlatformsUse of Platforms and necessary data
• Examples

Quality Risk Management (QRM) and risk based approach

• Importance of QRM
• Fields of application during development
• Tools-box
• How to perform, communicate and document Risk Assessment studies
• Examples

• 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

• What barriers are limiting the uptake of continuous manufacturing and how are these being addressed?

• How can you evaluate which processes require an intensified/continuous approach?

• Should companies commit to continuous for sustainability?

• How are emerging technologies assisting?

• How can you move from batch to continuous?

• Where do we want to be in 5/10 years? How can we get there?

• Key Points: Topics will include evolving methodologies for faster risk assessments, toxicology case studies, and perspectives on emerging risks in the field.
• Improved Virus Removal and Inactivation Methods: Exploring new techniques such as nanofiltration, viral capture systems, and robust orthogonal approaches.
• Global Harmonization Efforts: The role of organizations like ICH in standardizing guidelines across regions to simplify compliance.
• Integrated Risk Management Approaches: Using a risk-based approach to prioritize efforts based on the likelihood and impact of viral contamination.
• Continuous Manufacturing: Addressing viral safety in continuous bioprocessing, which offers potential efficiency gains but poses new safety challenges.
  
  

This full 1-day course will cover necessary considerations for developing new biologics in the CMC pathway.

Topics covered are:

The Introduction To The Paradigm of Process and Product Development

Regulatory Background

• Europe and US
• Product specific requirements
• Types of regulations and documents & where they can be found

Commune Technical Document (CTD) & ICH 4M

• Importance for Drug development
• Examples of CTD Requirements for Specific product entities
• Structure of the CTD and where to find the relevant information
• When and how to up-date

Stages in process and product development

• Pre-clinical development stage
• IND / IMPD development stage to start production of material for clinical trials
• IND / IMPD development stage to start production of material for late stage (phase III) clinical trials
• BLA / MMA stage

Requirements / Gates to pass to the next development stage

• Quality requirement of materials (starting materials, reagents and/or raw materials, consumables & auxiliary, primary and secondary packaging) used in the production process
• Definition of the status of Intermediate product, Drug substance, Excipients, Adjuvants (as applicable), others, Drug product
• From TPP, QTPP, CQA, CMA, CPPs to parameters and ranges
• Process flow diagram and control strategy
• Pooling/splitting and processing scale
• Linkage studies between (pCQAs / CQAs & PPs, pCMAs / CMAs & PPs) and identification of CPPs
• Use if small scale models
• Use of surrogate materials
• Scale -up & scale-out considerations
• Transfer requirements
• Process characterization
• Process data trending
• Performance qualification
• Clearance studies and assessments of process and product related impurities
• Leachable & Extractable assessments
• Sterile filter validation and integrity testing
• Adventitious viral risk assessment and safety studies
• Product storage and use conditions
• Compatibility data if applicable
• Process samples for product stability related studies
• Aseptic process simulation validation
• Cleaning and decontamination
• Equipment, including single use ones
• Transport qualification and validation
• GMP certificates
• Analytical Method development

Comparability study requirements

• Extend of studies are stage and change dependent
• When to perform?
• Number of batches to be included
• Studies to be included
• What can be considered as comparable?
• Step by step approach

Process, Material & Analytical Platform

• Why to work with Platforms?
• Definition of Platforms
• Establish PlatformsUse of Platforms and necessary data
• Examples

Quality Risk Management (QRM) and risk based approach

• Importance of QRM
• Fields of application during development
• Tools-box
• How to perform, communicate and document Risk Assessment studies
• Examples

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.