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Thursday, September 26, 2024 - Day Three of Main Conference - ET (Eastern Time, GMT-05:00)
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Thursday, September 26, 2024 - Day Three of Main Conference - ET (Eastern Time, GMT-05:00)
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Wellness Activities
7:15am - 7:45am
Yoga Session
Take a break from the science and find your flow by joining us for yoga. See you on the mat!
More details and sign up form to follow.
8:25am - 8:55am
Registration and Morning Coffee
Showing 5 of 5 Streams
Gene Therapy Manufacturing
Non Viral Delivery Development & Manufacturing
Analytical, Quality & Bioprocessing 4.0
Main Stage Exhibition Hall
Intro to Biopharma
BWB School 8:55am - 9:00am
Chairperson's Remarks: Gene Therapy Manufacturing
9:00am - 9:30am
Downstream Platform Process Development for AAV viral vectors; Challenges and Opportunities
- Parag Kumthekar - Lead Gene Therapy Downstream Process Sciences, UCB Pharma
9:30am - 10:00am
Improving Yield of Recovered Capsids during Downstream Recovery
- Seema Bhatlekar - Scientist, Johnson & Johnson Innovative Medicine
10:00am - 10:30am
Scientific Track Presentation by Refeyn
- Gael Nicolas - Key Account Manager, Refeyn
10:30am - 11:15am
Networking Refreshment Break in the Exhibit Hall
8:55am - 9:00am
Chairperson's Remarks: Non Viral Delivery Development & Manufacturing
9:00am - 9:30am
The Future of Nucleic Acid Medicine is Here
- Hari Pujar, PhD - Chief Operating Officer, Tessera Therapeutics
9:30am - 10:00am
Rapid Enzymatic Synthesis and Scaling of DNA Gene Therapy Molecules
- Anthony Dawson - Senior Scientist, Generation Bio
10:00am - 10:30am
Scientific Track Presentation
10:30am - 11:15am
Networking Refreshment Break in the Exhibit Hall
8:55am - 9:00am
Chairperson's Remarks: Analytical, Quality & Bioprocessing 4.0
9:00am - 9:30am
Total Analytical Control Strategy for Base Editing Gene Therapy
- Johnson Varghese - Head of Analytical Sciences & Development, Beam Therapeutics
9:30am - 10:00am
Total Control Strategy for Cellular Therapeutics – Smaller, Faster, Earlier Analytics
Dark Horse Consulting Representative
10:00am - 10:30am
Scientific Track Presentation
10:30am - 11:15am
Networking Refreshment Break in the Exhibit Hall
9:30am - 10:40am
Scientific Main Stage Presentation
10:40am - 10:45am
5 min Break
10:45am - 11:15am
Sustainability: Biomanufacturing challenges and the way Forward
- The Future of the Pharma Industry: Working Towards a Healthier Planet
- What are the key needs and goals of pharma and biopharma laboratories when it comes to sustainability?
- Biotechnology and pharma are among the world’s largest carbon-emitting industries. What steps need to be taken in the future to lower their position in this list of carbon emitters?
- What are the most significant challenges or barriers that the pharma industry faces in implementing more sustainable practices?
- The health sector generates four to five percent of total global emissions
- Mainly to do with the supply chain and the impact from globally shipping
- Complex global value chain- need to work together to solve sustainability and create circularity
- James Connelly - Chief Executive Officer, My Green Lab
- Manu Juneja - Director – Global Sustainability, Takeda
- Christine Riley Miller - Executive Director of Global Responsible Business and Sustainability, BeiGene
- Byron Austin - Head, Corporate Responsibility & ESG Management, Organon
- Partha Krishnan - Associate Director, Biosafety and Sustainability for North America R&D WX, Sanofi
9:00am - 10:00amBWB School
Introduction To Upstream Manufacturing
- 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.
- Michael Butler - Principal Investigator, Cell Technology, NIBRT
10:00am - 10:30amBWB School
Introduction To Downstream Manufacturing (PART 1)
- 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.
10:30am - 11:00amBWB School
Morning Break in Exhibit Hall
11:00am - 11:15amBWB School
Introduction To Downstream Manufacturing (PART 2)
- Highlight the importance of ensuring viral safety in biopharmaceutical products
- Describe methods for viral clearance, such as viral filtration and inactivation
- Present a few real-world examples of successful downstream bioprocessing projects.
- Discuss lessons learned and best practices from these case studies.
- Highlight current trends in downstream bioprocessing (e.g., continuous processing, single-use technologies).
- Discuss future directions and innovations in the field.
- Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair, Chemical Engineering, Penn State University
Showing 5 of 5 Streams
CGT Supply Chain, Logistics and Market Access
Non Viral Delivery Development & Manufacturing
Analytical, Quality & Bioprocessing 4.0
Main Stage Exhibition Hall
Intro to Biopharma
BWB School 11:15am - 11:45am
Exploring the Evolving Landscape of Supply Chain Management for CGT: Innovations, Tools, and Trends
- Jared Auclair, PhD - Vice Provost Research Economic Development, Director of Bioinnovation, College of Science at Northeastern University
11:45am - 12:15pm
Extending the Shelf Life of Single-Use Consumables
- Michelle Parziale - Senior Engineer - MS&T, Moderna
12:15pm - 12:45pm
Scientific Track Presentation by Avantor
12:45pm - 2:00pm
Luncheon in the Exhibit Hall (last chance to meet with exhibitors)
11:15am - 11:45am
Harnessing the Power of Extracellular Vesicles for Non-Viral Gene Therapy
- Qin Yu - VP of Research, Vesigen Therapeutics
11:45am - 12:15pm
Engineered Extracellular Vesicles for Clinical Application
- Christopher Locher - CEO & Co-Founder, Versatope, USA
12:15pm - 12:45pm
Scientific Track Presentation by Aldevron
- Patrick Paez, PhD - Technical Marketing Manager, Aldevron
12:45pm - 2:00pm
Luncheon in the Exhibit Hall (last chance to meet with exhibitors)
11:15am - 11:45am
Comparability Studies for Analytical Assessment Process Change
- Yiwei Zhao - Director, Analytical Development, Mural Oncology
11:45am - 12:15pm
Using Mass Spec for HCP Analysis – Pros and Cons of Immunoassays vs Mass Spec for HCP Analysis
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
12:15pm - 12:45pm
Scientific Track Presentation
12:45pm - 2:00pm
Luncheon in the Exhibit Hall (last chance to meet with exhibitors)
11:15am - 11:45am
Sustainability: Biomanufacturing challenges and the way Forward
- The Future of the Pharma Industry: Working Towards a Healthier Planet
- What are the key needs and goals of pharma and biopharma laboratories when it comes to sustainability?
- Biotechnology and pharma are among the world’s largest carbon-emitting industries. What steps need to be taken in the future to lower their position in this list of carbon emitters?
- What are the most significant challenges or barriers that the pharma industry faces in implementing more sustainable practices?
- The health sector generates four to five percent of total global emissions
- Mainly to do with the supply chain and the impact from globally shipping
- Complex global value chain- need to work together to solve sustainability and create circularity
- James Connelly - Chief Executive Officer, My Green Lab
- Manu Juneja - Director – Global Sustainability, Takeda
- Christine Riley Miller - Executive Director of Global Responsible Business and Sustainability, BeiGene
- Byron Austin - Head, Corporate Responsibility & ESG Management, Organon
- Partha Krishnan - Associate Director, Biosafety and Sustainability for North America R&D WX, Sanofi
11:45am - 11:50am
5 Minute Break
11:50am - 12:50pm
Scientific Main Stage Presentation
1:00pm - 1:10pm
Poster 3rd Place Winner
1:10pm - 1:20pm
Poster 2nd Place Winner
1:20pm - 1:30pm
Poster 1st Place Winner
1:30pm - 1:50pm
Scientific Main Stage Presentation
11:15am - 11:30amBWB School
Introduction To Downstream Manufacturing (PART 2) [Continued]
- Highlight the importance of ensuring viral safety in biopharmaceutical products
- Describe methods for viral clearance, such as viral filtration and inactivation
- Present a few real-world examples of successful downstream bioprocessing projects.
- Discuss lessons learned and best practices from these case studies.
- Highlight current trends in downstream bioprocessing (e.g., continuous processing, single-use technologies).
- Discuss future directions and innovations in the field.
- Andrew Zydney, Ph.D. - Bayard D. Kunkle Chair, Chemical Engineering, Penn State University
11:30am - 12:15pmBWB School
Working with CDMOs
- What are CDMOs?
- What are the benefits of working with CDMOs
- Guidance on selecting and working with a CDMO, there are several key considerations to ensure a successful partnership
- Defining Clear Objectives and Expectations
- Risk Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
12:15pm - 1:00pmBWB School
Digitalization in Biopharma
- Briefly explain the growing importance of digitalization, AI, and machine learning in the biopharma industry
- Key Areas of Digitalization
- Data Management and Integration
- Automation and Robotics
- Real-time Monitoring and Analytics
- Applications in Manufacturing and Supply Chain
- Use of digital twins and AI to optimize manufacturing processes and improve yield.
- AI-driven real-time monitoring and anomaly detection in production lines
- Use of AI for demand forecasting, inventory management, and logistics optimization
- Challenges and Considerations
- Case Studies
- Future Trends and Directions
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
1:00pm - 2:00pmBWB School
Lunch in Exhibition Hall
Showing 5 of 5 Streams
CGT Supply Chain, Logistics and Market Access
Non Viral Delivery Development & Manufacturing
Analytical, Quality & Bioprocessing 4.0
Main Stage Exhibition Hall
Intro to Biopharma
BWB School 2:00pm - 3:00pm
Overcoming Hurdles when distributing CGTs Across Multiple Regions and Markets
- Amish Patel - SVP, Technical Operations, Calidi Biotherapeutics
- Ben Doak - Head of Innovative Treatments, NHS England
2:00pm - 2:30pm
Strategic CMC considerations, challenges and opportunities for nonviral gene therapies
- Nathan Lee - Senior Director, Gene Therapy CMC, Poseida Therapeutics
2:30pm - 3:00pm
Machine learning driven design of multi-functional non-viral delivery systems
- Shashi Murthy, PhD - CTO and Co-Founder, Nanite Inc.
2:00pm - 2:30pm
ADC Analytical Strategy to Set Up Appropriate Criteria
- David Lee - Executive Director, Analytical Chemistry, Mersana Therapeutics
2:30pm - 3:00pm
Bispecific Impurities During Development – Discovery, Characterization and Assessment of a Novel Bispecific Impurity
- Monica Sadek - Technical Development Scientist 2, Protein Analytical Chemistry, Genentech
2:00pm - 2:30pm
Passport Giveaway
2:30pm - 3:30pm
Scientific Main Stage Presentation
2:00pm - 2:45pmBWB School
An introduction to Emerging Therapies: Unlocking the Future of Medicine
- 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 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.
- Strategies and approaches to best utilise available technologies in the development & production of emerging therapies.
- Lessons and experiences from our panellists.
2:45pm - 3:30pmBWB School
Introduction to Analytical & Quality Perspective
- Define analytical methods and their purpose in biopharmaceutical development and manufacturing
- Physicochemical Characterization - Techniques such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry (MS), and Nuclear Magnetic Resonance (NMR)
- Biological Assays - Cell-based assays, enzyme-linked immunosorbent assays (ELISA), and potency assays
- Microbiological Testing - Sterility testing, endotoxin testing, and microbial limits testing
- Role of Quality Assurance (QA) in Biopharma
- Quality by Design (QbD) and Risk Management
- Case Studies and Industry Examples
- Predict future advancements in analytical methods and quality assurance
- David H. Dumers - Quality Systems, Validation and Regulatory Compliance, Consultant
3:30pm - 3:35pm
Close of conference
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