Monday 15th September: Pre-Conference DayMonday, 15 September 2025 - ET (Eastern Time, GMT-05:00)

• How to navigate the complexities of manufacturing bi/multispecific antibodies
  • Developing a robust and reproducible process
  • Optimizing the process
  • Scaling-up
• Implementing PAT for critical process parameters

• Control of quality and consistency is crucial for a safe multispecific-antibody therapy
• Implementation of robust analytical methods to ensure quality
• Challenges in the characterization and control of heterogeneity

• 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.

• 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
    
    

• 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

• 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?

• 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

• 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 impact of linkers on drug stability, release, and therapeutic efficacy
  • Linkers’ crucial role in the development of an ADC-based therapy
• Choosing the optimum linker for your product:
  • Cleavable vs non-cleavable
  • Novel linkers, such as pH sensitive
  • How will linker choice affect properties of the conjugate, delivery success and efficacy

• 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

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.