Wednesday 19th March - Main Conference Day One - PT (Pacific Time, GMT-08:00)
- Insights and best practices for successful implementation
- Achieving scalable optimization
- Ensuring user adoption
- Ramila Peiris - Global Head of Process Data Management, ML and AI Platform, MSAT, Sanofi
As biopharmaceuticals grow in complexity and demand, the shift from traditional batch processing to integrated continuous manufacturing (ICB) has emerged as a compelling solution to reduce cost, waste and time to launch. However, integrating continuous manufacturing in bioprocessing requires a realistic evaluation of both opportunities and challenges. Key topics include the availability of commercially ready plug-and-play modular technologies, integration of real-time monitoring and development of robust control strategies. By examining the status of ICB implementation and recent innovations, we’ll outline a roadmap for adopting continuous bioprocessing practices and suggest actionable steps for industry stakeholders. The goal of this presentation is to provide a practical perspective on what is realistically achievable in the near term and to encourage a collaborative approach to realizing the potential of continuous manufacturing in bioprocessing.
- Veena Warikoo - VP, Global Technical Operations, AstraZeneca
- Eeshit Vaishnav - CEO, Sequome
- Satish Kallappagoudar - Associate Principal Scientist, Merck
- Hui Xiao - Associate Director, Regeneron
- Keshab Rijal - Principal Scientist, Amgen
- Ken Lee - Director, Bioprocess Technologies and Engineering, BioPharmaceuticals Development, R&D, AstraZeneca
- Chiali Liu - Senior Director, Drug Substance Development, Teva Pharmaceuticals
- Lihua Yang - Principal Research Scientist, AbbVie Bioresearch Center, USA
- Wenqin Ni - Senior Principal Scientist, Pfizer
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
- Jian Ren, Ph.D. - Principal Research Scientist I, AbbVie
- Ohnmar Khanal, Ph.D - Downstream Technology Lead, Spark Therapeutics
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
- Adam Haskett - Senior Director, External Manufacturing, Cargo Therapeutics, USA
- Kate Rochlin - Chief Operating Officer, IN8bio
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
- Eva Rubio-Marrero - Senior Scientist II, AbbVie
- Cynthia Lam - Technical Development Scientist, Genentech
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
- Neil McCracken, PhD - Principal Research Scientist, Upstream Process Development, Group Leader, Elanco
- Alexandria Triozzi - Technical Development Engineer III, Biogen
- How CDMOs have evolved in the last 5 years and what to expect in the coming years;
- Geopolitical uncertainty and its impact on outsourced manufacturing;
- Collaboration to understand the changing needs of pharma and biotech.
- Vadim Klyushnichenko - VP Bio/Pharmaceutical Development & Quality, Calibr-Skaggs Institute for Innovative Medicines
- Lihua Yang - Principal Research Scientist, AbbVie Bioresearch Center, USA
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
- Younghoon Oh - Senior Scientist, API Protein, Johnson & Johnson Innovative Medicine
- Jonas Immel-Brown - Scientist - Technical Development, Biogen
- Kendall Feshuk - Senior Manager, Member Development, Rx-360, USA
- Lakshman Prakash Balajepalli - Manage QA, Cedars Sinai Biomanufacturing Center, USA
- Hui-Lan Hu - Associate principle scientist, AstraZeneca
- Yuansheng Yang - Senior Principle Scientist 1, A*STAR
- Larry Forman - CEO, CHO PLUS
- Stephen Zano - Director, Early Research and Process Development, Sarepta Therapeutics
- Jesse Richter - Executive Director, Tech Transfer and Validation - Global Technical Operations, Biopharmaceuticals, AstraZeneca
- Noman Khan - Associate Director External Engagement, University of Utah
Novel modalities propose unique challenges for their purification and removal of impurities - how can purification processes be optimized for these novel modalities?
Roundtable groups discussing:
Emerging technologies and approaches utilized for DNA/RNA/mRNA downstream processing
- Scaling these technologies for growth;
- Unique purification challenges and solutions for viral vectors and mRNA;
- Challenges when transitioning from membranes for viral vector/mRNA based therapeutics.
Addressing challenges related to ADC degradation and impurity clearance
- Developing analytical methods for monitoring ADC stability and purity;
- Optimizing conjugation processes to prevent downstream bottlenecks;
- Strategies for managing heterogeneity in ADC products;
- The impact of ADC instability on downstream processing and product quality.
Overcoming issues for purification for Radiopharmaceuticals
- Unique challenges associated with handling and purifying radio-labelled compounds;
- Ensuring the safety and efficacy of radiopharmaceuticals through effective purification;
- Regulatory considerations for the purification of radiopharmaceuticals;
- The role of automation and robotics in radiopharmaceutical purification.
Achieving optimal downstream purity during vaccine development
- Specific purification challenges associated with different vaccine types (e.g., viral, bacterial, subunit);
- Strategies for removing impurities and contaminants from vaccine products;
- The importance of maintaining vaccine stability and potency throughout purification;
- Regulatory requirements for vaccine purity and quality.
30 minute roundtable discussions, 30 mins feedback to group and key takeaways.
- Attila Nagy - Associate Director – Downstream Process Development, National Institute of Health
- Mukunda Krishna - Associate Director, External Manufacturing, Tech Ops and Supply Chain, Arcturus Therapeutics
- Ensuring the commercial sustainability of cell & gene therapies;
- Tackling barriers and identifying opportunities for commercialization;
- Innovative payment models in the US and globally;
- Strategies for attracting investment to ensure smooth transition from bench to bedside.
- Adam Haskett - Senior Director, External Manufacturing, Cargo Therapeutics, USA
- Kate Rochlin - Chief Operating Officer, IN8bio
- Dan Oliver - CEO and Founder, Rejuvenate Bio, USA