Day 1 - EST/EDT (Eastern Daylight, GMT-4)
Day 1 - EST/EDT (Eastern Daylight, GMT-4)
Course Objective: This quick but comprehensive tutorial will provide an overview of the regulatory and quality principles that guide the analytical studies for all biological products, with emphasis on the specific elements applicable to complex MODALITIES such as gene and cell therapy. Emerging best practices in analytical methods for characterization, comparability, release and stability testing of gene and cell therapy will be presented. The rationale behind the requirements, with supporting references, will be provided. Attendees to this class will receive electronic copies of all reference guidances and publications discussed in the class.
Course Outline:
• Overview of CMC analytical regulatory deliverables for all biological products
• Specific additional guidances applicable to analytics of gene and cell therapy products
• Core principles of analytical characterization, comparability and control of complex biological products
• Practices for establishing the right ‘analytical tool kit’ for gene and cell therapy products
• Challenges in establishing product reference standards for use with complex biologics
• Emerging horizontal method standards for use with gene and cell therapy product analytical methods
• Key elements of compendial and non-compendial analytical methods lifecycles for biological products
• Quality requirements for documentation and data integrity of gene and cell therapy analytical studies
• Interactive Q&A with class speaker
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
CDMO Selection: Models and Process
Contract and Quality Agreement Negotiation
Tech Transfer: Best practices and risk management
Quality Assurance and Quality Control
On- Going Manufacturing: Organisational models and interactions
Life Cycle Management
Relationship Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
Introduction to Tech Transfer
Definition of TT
Tech transfer: a Project with Challenges
Session 1 : Formal Aspects
Regulatory concerns ; product comparability
Tech Transfer Procedure, Protocol & Report
Session 2: Tools for Tech Transfer
Transfer of Information
Dealing with Scale up and changes
Analytical Transfer
Session 3 : Complexities of Tech Transfer
Complexity and Risk Factors
The importance of communication
Optimising the transfer programme
Workshop: Tech Transfer in the life -cycle
- Thomas Chattaway - Senior Life Science Consultant, Independent
Pharma 4.0 is the perceived enabler to accelerate the product life cycle, ensure swift process validation, avoid fail batches and optimize productivity. However, for this, process understanding, the link between CPPs, CQAs and KPIs, need to be identified and deployed, which is still unresolved in industrial practice. This is due to the complexity of the data sources, the missing methods of data contextualization and due to the interactivity of a multitude of unit operations. The commonly accepted hypothesis is that sound data science and digital twin approaches along Pharma principles will be a success factor in this endeavor.
Course Outline:
Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool PAS-X Savvy®. Methods and best practices embedded in workflows based on data science ad digital twins, using case studies and hands-on exercises. Designed for the biopharmaceutical and industrial biotech industry.
Digital Bioprocess Lab/ Plant: Best practices for bioprocess data management
- Data Management Workflows
- Handling Data of different frequencies and dimensionality
- Monitoring & Trending, raw data visualization
- Inspecting your data for outliers
Bioprocess data analytics: Best practices
- Setting process phases
- Conversion of raw data to reliable feature based information
- Integrated Process Analysis over multiple unit operations
- Root Cause Analysis of process variability
- CPV and Golden Batch Analysis
Digital twins for CMC knowledge capture and process control
- Workflows for generation of digital twins
- Applications of digital twins in efficient experimental designs
- Applications of digital twins for process prediction and control
- Integrated process modelling for a robust control strategy
- Christoph Herwig - Founder Lisalis GmbH, former Professor for Bioprocess Engineering, Lisalis GmbH
- Anurag Khetan, PhD - Executive Director, Global Upstream and Cell Line Development, Biologics Development, Bristol-Myers Squibb
- Christine DeMaria - Director, Cell Line Development, Sanofi
- Xiangming Li - Associate Director, Mammalian Expression Technology CoE, GSK Vaccines
- David Gemmell - MSAT Biomanufacturing Engineer, Merck & Co.
- Adriana Coll De Pena - Biomedical Engineering Ph.D. Candidate, Brown University
- Karenna Smith - Senior Associate Scientist, Pfizer
- Christopher Locher - CEO & Co-Founder, Versatope, USA
- Capricor Therpaeutics - ., .
- Shelley Hartman - CEO, Aegle Therapeutics Corporation
Course Objective: This quick but comprehensive tutorial will provide an overview of the regulatory and quality principles that guide the analytical studies for all biological products, with emphasis on the specific elements applicable to complex MODALITIES such as gene and cell therapy. Emerging best practices in analytical methods for characterization, comparability, release and stability testing of gene and cell therapy will be presented. The rationale behind the requirements, with supporting references, will be provided. Attendees to this class will receive electronic copies of all reference guidances and publications discussed in the class.
Course Outline:
• Overview of CMC analytical regulatory deliverables for all biological products
• Specific additional guidances applicable to analytics of gene and cell therapy products
• Core principles of analytical characterization, comparability and control of complex biological products
• Practices for establishing the right ‘analytical tool kit’ for gene and cell therapy products
• Challenges in establishing product reference standards for use with complex biologics
• Emerging horizontal method standards for use with gene and cell therapy product analytical methods
• Key elements of compendial and non-compendial analytical methods lifecycles for biological products
• Quality requirements for documentation and data integrity of gene and cell therapy analytical studies
• Interactive Q&A with class speaker
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
CDMO Selection: Models and Process
Contract and Quality Agreement Negotiation
Tech Transfer: Best practices and risk management
Quality Assurance and Quality Control
On- Going Manufacturing: Organisational models and interactions
Life Cycle Management
Relationship Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
Introduction to Tech Transfer
Definition of TT
Tech transfer: a Project with Challenges
Session 1 : Formal Aspects
Regulatory concerns ; product comparability
Tech Transfer Procedure, Protocol & Report
Session 2: Tools for Tech Transfer
Transfer of Information
Dealing with Scale up and changes
Analytical Transfer
Session 3 : Complexities of Tech Transfer
Complexity and Risk Factors
The importance of communication
Optimising the transfer programme
Workshop: Tech Transfer in the life -cycle
- Thomas Chattaway - Senior Life Science Consultant, Independent
Pharma 4.0 is the perceived enabler to accelerate the product life cycle, ensure swift process validation, avoid fail batches and optimize productivity. However, for this, process understanding, the link between CPPs, CQAs and KPIs, need to be identified and deployed, which is still unresolved in industrial practice. This is due to the complexity of the data sources, the missing methods of data contextualization and due to the interactivity of a multitude of unit operations. The commonly accepted hypothesis is that sound data science and digital twin approaches along Pharma principles will be a success factor in this endeavor.
Course Outline:
Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool PAS-X Savvy®. Methods and best practices embedded in workflows based on data science ad digital twins, using case studies and hands-on exercises. Designed for the biopharmaceutical and industrial biotech industry.
Digital Bioprocess Lab/ Plant: Best practices for bioprocess data management
- Data Management Workflows
- Handling Data of different frequencies and dimensionality
- Monitoring & Trending, raw data visualization
- Inspecting your data for outliers
Bioprocess data analytics: Best practices
- Setting process phases
- Conversion of raw data to reliable feature based information
- Integrated Process Analysis over multiple unit operations
- Root Cause Analysis of process variability
- CPV and Golden Batch Analysis
Digital twins for CMC knowledge capture and process control
- Workflows for generation of digital twins
- Applications of digital twins in efficient experimental designs
- Applications of digital twins for process prediction and control
- Integrated process modelling for a robust control strateg
- Christoph Herwig - Founder Lisalis GmbH, former Professor for Bioprocess Engineering, Lisalis GmbH
- Jing Guo - Research Scientist, MIT
- Michael Eric Lloyd - Senior Principal Biologist, Genetic Molecular Cell Biology, Eli Lilly
- Adam Brown, Ph.D. - Lecturer in DNA Engineering, University of Sheffield
- Mukunda Krishna - Associate Director, External Manufacturing, Tech Ops and Supply Chain, Arcturus Therapeutics
- NurExone Biologic - TBC, NurExone Biologic
Course Objective: This quick but comprehensive tutorial will provide an overview of the regulatory and quality principles that guide the analytical studies for all biological products, with emphasis on the specific elements applicable to complex MODALITIES such as gene and cell therapy. Emerging best practices in analytical methods for characterization, comparability, release and stability testing of gene and cell therapy will be presented. The rationale behind the requirements, with supporting references, will be provided. Attendees to this class will receive electronic copies of all reference guidances and publications discussed in the class.
Course Outline:
• Overview of CMC analytical regulatory deliverables for all biological products
• Specific additional guidances applicable to analytics of gene and cell therapy products
• Core principles of analytical characterization, comparability and control of complex biological products
• Practices for establishing the right ‘analytical tool kit’ for gene and cell therapy products
• Challenges in establishing product reference standards for use with complex biologics
• Emerging horizontal method standards for use with gene and cell therapy product analytical methods
• Key elements of compendial and non-compendial analytical methods lifecycles for biological products
• Quality requirements for documentation and data integrity of gene and cell therapy analytical studies
• Interactive Q&A with class speaker
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
CDMO Selection: Models and Process
Contract and Quality Agreement Negotiation
Tech Transfer: Best practices and risk management
Quality Assurance and Quality Control
On- Going Manufacturing: Organisational models and interactions
Life Cycle Management
Relationship Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
Introduction to Tech Transfer
Definition of TT
Tech transfer: a Project with Challenges
Session 1 : Formal Aspects
Regulatory concerns ; product comparability
Tech Transfer Procedure, Protocol & Report
Session 2: Tools for Tech Transfer
Transfer of Information
Dealing with Scale up and changes
Analytical Transfer
Session 3 : Complexities of Tech Transfer
Complexity and Risk Factors
The importance of communication
Optimising the transfer programme
Workshop: Tech Transfer in the life -cycle
- Thomas Chattaway - Senior Life Science Consultant, Independent
Pharma 4.0 is the perceived enabler to accelerate the product life cycle, ensure swift process validation, avoid fail batches and optimize productivity. However, for this, process understanding, the link between CPPs, CQAs and KPIs, need to be identified and deployed, which is still unresolved in industrial practice. This is due to the complexity of the data sources, the missing methods of data contextualization and due to the interactivity of a multitude of unit operations. The commonly accepted hypothesis is that sound data science and digital twin approaches along Pharma principles will be a success factor in this endeavor.
Course Outline:
Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool PAS-X Savvy®. Methods and best practices embedded in workflows based on data science ad digital twins, using case studies and hands-on exercises. Designed for the biopharmaceutical and industrial biotech industry.
Digital Bioprocess Lab/ Plant: Best practices for bioprocess data management
- Data Management Workflows
- Handling Data of different frequencies and dimensionality
- Monitoring & Trending, raw data visualization
- Inspecting your data for outliers
Bioprocess data analytics: Best practices
- Setting process phases
- Conversion of raw data to reliable feature based information
- Integrated Process Analysis over multiple unit operations
- Root Cause Analysis of process variability
- CPV and Golden Batch Analysis
Digital twins for CMC knowledge capture and process control
- Workflows for generation of digital twins
- Applications of digital twins in efficient experimental designs
- Applications of digital twins for process prediction and control
- Integrated process modelling for a robust control strategy
- Christoph Herwig - Founder Lisalis GmbH, former Professor for Bioprocess Engineering, Lisalis GmbH
- Thomas Kelly - Scientist, Janssen Research & Development LLC
- Christina Tsai, PhD - Senior Scientist, Lead of Cell Line Development, IGM Biosciences
- Xiangming Li - Associate Director, Mammalian Expression Technology CoE, GSK Vaccines
- Aaron Allen - Director, Global Quality External Engagement, Moderna
- Raymond Swetenburg - Director of Discovery, Aruna Bio
- Spencer Marsh - Chief Scientific Officer, Tiny Cargo Company, USA
Course Objective: This quick but comprehensive tutorial will provide an overview of the regulatory and quality principles that guide the analytical studies for all biological products, with emphasis on the specific elements applicable to complex MODALITIES such as gene and cell therapy. Emerging best practices in analytical methods for characterization, comparability, release and stability testing of gene and cell therapy will be presented. The rationale behind the requirements, with supporting references, will be provided. Attendees to this class will receive electronic copies of all reference guidances and publications discussed in the class.
Course Outline:
• Overview of CMC analytical regulatory deliverables for all biological products
• Specific additional guidances applicable to analytics of gene and cell therapy products
• Core principles of analytical characterization, comparability and control of complex biological products
• Practices for establishing the right ‘analytical tool kit’ for gene and cell therapy products
• Challenges in establishing product reference standards for use with complex biologics
• Emerging horizontal method standards for use with gene and cell therapy product analytical methods
• Key elements of compendial and non-compendial analytical methods lifecycles for biological products
• Quality requirements for documentation and data integrity of gene and cell therapy analytical studies
• Interactive Q&A with class speaker
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
Through a series of presentations, case studies and interactive discussions and exercises this course will focus on CDMO oversight- selection, negotiation, tech transfer and life cycle management specifically for cell and gene therapy products.
Some of the topics to be discussed include:
CDMO Selection: Models and Process
Contract and Quality Agreement Negotiation
Tech Transfer: Best practices and risk management
Quality Assurance and Quality Control
On- Going Manufacturing: Organisational models and interactions
Life Cycle Management
Relationship Management
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
Introduction to Tech Transfer
Definition of TT
Tech transfer: a Project with Challenges
Session 1 : Formal Aspects
Regulatory concerns ; product comparability
Tech Transfer Procedure, Protocol & Report
Session 2: Tools for Tech Transfer
Transfer of Information
Dealing with Scale up and changes
Analytical Transfer
Session 3 : Complexities of Tech Transfer
Complexity and Risk Factors
The importance of communication
Optimising the transfer programme
Workshop: Tech Transfer in the life -cycle
- Thomas Chattaway - Senior Life Science Consultant, Independent
Pharma 4.0 is the perceived enabler to accelerate the product life cycle, ensure swift process validation, avoid fail batches and optimize productivity. However, for this, process understanding, the link between CPPs, CQAs and KPIs, need to be identified and deployed, which is still unresolved in industrial practice. This is due to the complexity of the data sources, the missing methods of data contextualization and due to the interactivity of a multitude of unit operations. The commonly accepted hypothesis is that sound data science and digital twin approaches along Pharma principles will be a success factor in this endeavor.
Course Outline:
Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool PAS-X Savvy®. Methods and best practices embedded in workflows based on data science ad digital twins, using case studies and hands-on exercises. Designed for the biopharmaceutical and industrial biotech industry.
Digital Bioprocess Lab/ Plant: Best practices for bioprocess data management
- Data Management Workflows
- Handling Data of different frequencies and dimensionality
- Monitoring & Trending, raw data visualization
- Inspecting your data for outliers
Bioprocess data analytics: Best practices
- Setting process phases
- Conversion of raw data to reliable feature based information
- Integrated Process Analysis over multiple unit operations
- Root Cause Analysis of process variability
- CPV and Golden Batch Analysis
Digital twins for CMC knowledge capture and process control
- Workflows for generation of digital twins
- Applications of digital twins in efficient experimental designs
- Applications of digital twins for process prediction and control
- Integrated process modelling for a robust control strategy
- Christoph Herwig - Founder Lisalis GmbH, former Professor for Bioprocess Engineering, Lisalis GmbH
- Sarah Topfer - Technical Lead, Cell Line Development and Media Optimisation, Vow Foods
- Yizhou Zhou, PhD - Head of Cell Line Technology, Gene Therapy Development, Biogen
- Chris Paradise - VP, Research & Development, Rion
- Gianluca Roma - CEO, EV Therapeutics
The BWB Awards at Biotech Week Boston brings together the faces and names that make the Boston community the beating heart of the biotech world.
Recognizing inspiring achievements from 2023; the 2023 award categories are:
- START-UP OF THE YEAR
- DE&I INITIATIVE
- BIOTECH INNOVATION
- DEAL OF THE YEAR
- TALENT ACCELERATION
- SUSTAINABILITY INITIATIVE
- CLINICAL ADVANCE OF THE YEAR
- LIFETIME ACHIEVEMENT AWARD
- BOSTON HIGHLIGHT
- TRANSFORMATIONAL THERAPY
The Biotech Week Boston Awards will be an evening dinner ceremony held on Monday September 18th, from 6:00pm—10:00pm. This awards ceremony honors the top individuals, companies, and organizations that make the country’s life sciences ecosystem the most vibrant and innovative in the world.
06:00 Registration Opens and Welcome Reception
07:15 Attendees Seated and Starters Served
07:30 Dinner + Drinks Served
08:15 Awards Presented
09:15 Celebratory Drinks & Casino Party
10:00 Gala Closes
For more information on the BWB awards please visit: BWB Awards