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

Biopharmaceutical process development is often challenged by long experimental timelines and high resource demands. To overcome these bottlenecks, intensified and model-based Design of Experiments (DoE) approaches are transforming how bioprocesses are developed, enabling faster, more cost-effective production.

This presentation will demonstrate how advanced DoE strategies, combined with Hybrid Models, can significantly reduce experimental effort while improving process understanding and robustness. By integrating AI-assisted digital process twins, it becomes possible to simulate and optimize bioprocess parameters before running costly and time-consuming lab experiments. Case studies will illustrate how these approaches enhance upstream process efficiency, accelerate decision-making, and lead to better-controlled production processes with minimal trial-and-error.

Join this session to explore how intensified and model-based DoE methodologies are reshaping bioprocess development, driving innovation, and improving scalability in an increasingly competitive biopharmaceutical landscape.

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
  
  

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

Transport provided will leave Congress Center Hamburg at 11:30am to depart for Richter Biologics facility in Bovenau

*This site tour is invitation only*

1. In silico design, scalability, and optimization of a bioreactor platform
2. Introducing the next generation of single-use mixers
3. Purification and filtration strategies for antibody derived entities including bispecific, fragments and biosimilars
4. 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

1. Current status of the gene therapy market and key challenges in viral vector manufacturing
2. From transient to stable producer cell lines for AAV production: balancing flexibility, scalability, and cost reduction
3. Viral vector production: Choosing between adherence and suspension methods; scale-up solutions for both approaches
4. 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

What are the key points to consider when choosing the right CDMO for your product? Why Richter BioLogics is the best partner to support your product.

*This site tour is invitation only*