Tuesday 18th March - Pre-Conference DayTuesday, 18 March 2025 - PT (Pacific Time, GMT-08:00)

• Process improvements to increase productivity
• Process monitoring and control strategy targeting intensified continuous processing

Advances in Chinese Hamster Ovary (CHO) cell technologies, cell culture media composition, and bioreactor operating parameters have increased monoclonal antibody titers in the bioreactor greater than 10-fold over the last 20 years. These high-titer batch processes offer increased productivity (mass of biologics produced per unit of time and area) and allow for meeting the growing demand for protein therapeutics. However, fitting the high-titer processes in legacy manufacturing plants, typically designed for low titer processes, can be challenging due to product pool volumes that exceed intermediate hold tank volumetric capacities. A solution to mitigate volume-related challenges is concentrating intermediate product streams in-line by single pass tangential flow filtration (SPTFF) to fit within fixed tank assets. This talk will elaborate on various considerations related to developing, characterizing, and scaling up SPTFF processes for in-line concentration of the intermediate product streams to fit high titer processes in legacy manufacturing plants. Specifically, the discussion will include how to determine the development goals for the SPTFF process, perform a risk assessment, and identify parameter ranges for robust process performance while minimizing the cost of goods sold (COGS). Results from bench-scale and pilot-scale experiments across different molecules will also be shared, showing the minimal impact of incorporating SPTFF in high-titer batch processes on product quality. Overall, SPTFF provides the tools to address many volume-related facility-fit constraints associated with high-titer processes.

• Overview of the CDMO Landscape for biopharma and biotech
  • Key players and their capabilities
  • How the market is changing
• CDMO Selection
  • Considerations for CDMO selection
  • Framework for selecting the right partner
• Contractual agreements
  • Different forms of contracts
  • Setting expectations and fostering a collaborative environment
  • Timelines and opportunities for acceleration
• Executing a seamless tech transfer
  • Key challenges and advice

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

1. Control Strategy: What are the Challenges in Process Control for Continuous Processing and How Can We Overcome These?
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?

30 minutes to discuss within groups then feedback main points for 5 minutes.

This session will dive into the decision-making process behind GenVivo’s choice to manufacture vector-based immunotherapies in-house rather than partnering with an external manufacturer. We will examine key considerations, including the time and cost implications of establishing an internal manufacturing facility, as well as strategic factors that influence whether to build or outsource production. Attendees will gain practical insights into the complexities of this decision, applicable to companies developing cutting-edge therapies.

The majority of innovative ideas and disruptive technologies are nucleated at academic and educational institutions. However, these organizations have limited budget and lack the process development and manufacturing infrastructure, particularly if their advanced products belong to different technological platforms. This gap can be closed by contract development and manufacturing organizations (CDMOs), which remain crucial to new drug process development, manufacturing and commercialization.

The goal of this presentation is to provide the framework for the development of modern biologics through global CDMOs. Two case studies are presented: small molecule-antibody conjugate (SMAC) and chimeric antigen receptor T-cells (CAR-T), which are currently undergoing clinical trials in the immuno-oncology field. Each of these programs required the involvement of five different CDMOs located in different parts of the world due to the unique nature of these drug products. The CDMO selection process includes business documentation, GMP due diligence process, CDMO structure analysis, communication, technical expertise, and establishing a timeline, and a budget. This presentation will cover the key benchmarks in analytical and process development to ensure a successful manufacturing outcome.

• Creating modular systems to ensure flexibility and scalability of processes;
• Facility considerations for the move to continuous;
• Learning from early successes and failures to improve processes.

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

• Managing ongoing relationship with your CDMO
  • Having a proactive approach to project management to avoid costly delays
  • Conflict resolution
• Implementing robust risk management frameworks
  • Utilize with clear, concise and collaborative communication
• Fostering a culture of continuous improvement

• 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?

• How to select the right CDMO partner?
• Establishing clear communication channels and expectations;
• Fostering a collaborative problem-solving approach;
• Best practices for seamless technology transfer.