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

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

Setting the Scene : CMC Studies in the life cycle

• 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
  
  

• 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.

The presentation will address the revision of ICH Q5A(R2) Viral Safety Testing of Biological Products, with a focus on the introduction of Next Generation Sequencing (NGS) tests to detect a broad spectrum of viruses. It will discuss NGS implementation, validation and regulatory considerations, using the EFPIA Position Paper on NGS for viral safety testing and other publications as references.

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

Topics covered are:

Requirements from Pre-Clinical to Phase 2 CT

• 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

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?

• In silico design, scalability, and optimization of a bioreactor platform
• Introducing the next generation of single-use mixers
• Purification and filtration strategies for antibody derived entities including bispecific, fragments and biosimilars
• Risk analysis and practical solutions for pre-use post-sterilization integrity testing (pupsit) implementation

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

Topics covered are:

Requirements from Pre-Clinical to Phase 2 CT

• 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

• 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

• Current status of the gene therapy market and key challenges in viral vector manufacturing
• From transient to stable producer cell lines for AAV production: balancing flexibility, scalability, and cost reduction
• Viral vector production: Choosing between adherence and suspension methods; scale-up solutions for both approaches
• Outsourcing process development: A secure and efficient path to commercialization

• 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.
• Challenges and solutions for Novel Modalities: Products such as Bispecifics, ADCs and Cell & Gene Therapies.
• 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:

Case Study and Group Exercise:

• 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

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.