Monday, September 23, 2024 - Pre-Conference Workshops - EST/EDT (Eastern Daylight, GMT-4)
Monday, September 23, 2024 - Pre-Conference Workshops - EST/EDT (Eastern Daylight, GMT-4)
- David Vikström - CTO, Xbrane Bioscience
- Jeffrey Hausfeld - Chairman of the Board, Biofactura
- Ensuring the quality and consistency of the end product
- Conjugation challenges associated with drug design
- Effective collaboration with CMOs in Preparation for commercialization of ADCs
- Process design and implementation for bi- and multi-specfic ADCs
- Elucidating the drug to antibody ratio (DAR) of your product
- Analytical considerations for the characterisation of complex biologics
Objective: This 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.
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
What is this track about?
This is a full day course from 9am - 4pm.
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
Who should attend?
Process Development Scientists/Engineers
Business Development Managers
Project Managers
Regulatory Affairs Professionals
Quality Assurance/Quality Control Managers
Manufacturing Operations Managers
Supply Chain Managers
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
What is this track about?
This is a full day course from 9am – 4pm
- Introduction to Tech Transfer
- Definition of TT
- Tech transfer: a Project with Challenges
- Session 1: Formal Aspects including Regulatory concerns ; product comparability, Tech Transfer Procedure, Protocol & Report
- Session 2: Tools for Tech Transfer including Transfer of Information, Dealing with Scale up and changes, Analytical Transfer
- Session 3 : Complexities of Tech Transfer including Complexity and Risk Factors, The importance of communication, Optimising the transfer programme
- Session 4: Workshop Case Study and Group Activity
Who Should Attend?
Process Development Scientists/Engineers
Manufacturing Operations Managers
Quality Assurance/Quality Control Managers
Regulatory Affairs Professionals
Project Managers
Supply Chain Managers
Analytical Development Scientists/Engineers
Validation Specialists
Operations and Production Personnel
Research and Development Scientists
Business Development Managers
- Thomas Chattaway - Senior Life Science Consultant, Independent
This workshop will explore the current initiatives, innovative strategies and new technologies designed to drive sustainability of biologics process development and manufacturing.
- Define the Current State of Sustainability in 2024
- Case Studies on Current Initiatives from End Users and Vendors
- Help Individuals develop sustainability strategies and solutions best suited for their companies
- Interactive Discussions on Challenges with Single Use and Environmental and Economic Modeling
- A Look Ahead - What’s Next and What’s Needed?
- James Vogel - Director and Founder, The BioProcess Institute
- What to expect?
- Common pitfalls
- Charles Andres - Shareholder, Greenberg Traurig
- Sanjeev Gupta - Sr. Vice President and Head Biosimilars, Ipca Laboratories
- Case study
- Working with components with short half life's
- Sourcing and ensuring traceability for radioactive supply
- Exploring the unique challenges of T-cell engager manufacturing compared to traditional biologics
- Pre-emptive design and optimization of robust production processes
- Case study example
Objective: This 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.
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
What is this track about?
This is a full day course from 9am - 4pm.
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
Who should attend?
Process Development Scientists/Engineers
Business Development Managers
Project Managers
Regulatory Affairs Professionals
Quality Assurance/Quality Control Managers
Manufacturing Operations Managers
Supply Chain Managers
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
What is this track about?
This is a full day course from 9am – 4pm
- Introduction to Tech Transfer
- Definition of TT
- Tech transfer: a Project with Challenges
- Session 1: Formal Aspects including Regulatory concerns ; product comparability, Tech Transfer Procedure, Protocol & Report
- Session 2: Tools for Tech Transfer including Transfer of Information, Dealing with Scale up and changes, Analytical Transfer
- Session 3 : Complexities of Tech Transfer including Complexity and Risk Factors, The importance of communication, Optimising the transfer programme
- Session 4: Workshop Case Study and Group Activity
Who Should Attend?
Process Development Scientists/Engineers
Manufacturing Operations Managers
Quality Assurance/Quality Control Managers
Regulatory Affairs Professionals
Project Managers
Supply Chain Managers
Analytical Development Scientists/Engineers
Validation Specialists
Operations and Production Personnel
Research and Development Scientists
Business Development Managers
- Thomas Chattaway - Senior Life Science Consultant, Independent
This workshop will explore the current initiatives, innovative strategies and new technologies designed to drive sustainability of biologics process development and manufacturing.
- Define the Current State of Sustainability in 2024
- Case Studies on Current Initiatives from End Users and Vendors
- Help Individuals develop sustainability strategies and solutions best suited for their companies
- Interactive Discussions on Challenges with Single Use and Environmental and Economic Modeling
- A Look Ahead - What’s Next and What’s Needed?
- James Dean Vogel - Founder and Director , The BioProcess Institute
- Alla Polozova - Director, Process Development, Amgen
- Ensuring effective CMC, analytical development, and quality monitoring for the production of safe and consistent therapeutics in line with regulatory advice
- Anticipating potential bottlenecks and addressing these to ensure smooth scalability.
- Working with partners to assist in the manufacturing of next generation therapeutics.
- Preparing a secure and reliable network of suppliers by analysing the vulnerabilities of complex bioprocessing supply chains
- Best practices for successful collaboration and transparency with stakeholders/vendors
- Strategies to mitigate risk and ensure reliability.
Objective: This 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.
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
What is this track about?
This is a full day course from 9am - 4pm.
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
Who should attend?
Process Development Scientists/Engineers
Business Development Managers
Project Managers
Regulatory Affairs Professionals
Quality Assurance/Quality Control Managers
Manufacturing Operations Managers
Supply Chain Managers
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
What is this track about?
This is a full day course from 9am – 4pm
- Introduction to Tech Transfer
- Definition of TT
- Tech transfer: a Project with Challenges
- Session 1: Formal Aspects including Regulatory concerns ; product comparability, Tech Transfer Procedure, Protocol & Report
- Session 2: Tools for Tech Transfer including Transfer of Information, Dealing with Scale up and changes, Analytical Transfer
- Session 3 : Complexities of Tech Transfer including Complexity and Risk Factors, The importance of communication, Optimising the transfer programme
- Session 4: Workshop Case Study and Group Activity
Who Should Attend?
Process Development Scientists/Engineers
Manufacturing Operations Managers
Quality Assurance/Quality Control Managers
Regulatory Affairs Professionals
Project Managers
Supply Chain Managers
Analytical Development Scientists/Engineers
Validation Specialists
Operations and Production Personnel
Research and Development Scientists
Business Development Managers
- Thomas Chattaway - Senior Life Science Consultant, Independent
This workshop will explore the current initiatives, innovative strategies and new technologies designed to drive sustainability of biologics process development and manufacturing.
- Define the Current State of Sustainability in 2024
- Case Studies on Current Initiatives from End Users and Vendors
- Help Individuals develop sustainability strategies and solutions best suited for their companies
- Interactive Discussions on Challenges with Single Use and Environmental and Economic Modeling
- A Look Ahead - What’s Next and What’s Needed?
- James Dean Vogel - Founder and Director , The BioProcess Institute
- David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University
- What Are the requirements across several countries?
- How can we align requirements and gain approval across multiple regions?
- Why do the requirements differ so much?
- Utilizing AI-aided design to anticipate potential manufacturing challenges
- Implementing AI into pre-existing bioprocessing workflows
- Case study examples
- Applications of generative AI within bioprocessing and next-gen therapeutics manufacturing
- Optimization of process parameters and product design for efficient production
- Ethical considerations and responsible development of AI in biomanufacturing – what to keep in mind.
Objective: This 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.
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
What is this track about?
This is a full day course from 9am - 4pm.
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
Who should attend?
Process Development Scientists/Engineers
Business Development Managers
Project Managers
Regulatory Affairs Professionals
Quality Assurance/Quality Control Managers
Manufacturing Operations Managers
Supply Chain Managers
- James Blackwell - President and Principal Consultant, The Windshire Group, LLC
What is this track about?
This is a full day course from 9am – 4pm
- Introduction to Tech Transfer
- Definition of TT
- Tech transfer: a Project with Challenges
- Session 1: Formal Aspects including Regulatory concerns ; product comparability, Tech Transfer Procedure, Protocol & Report
- Session 2: Tools for Tech Transfer including Transfer of Information, Dealing with Scale up and changes, Analytical Transfer
- Session 3 : Complexities of Tech Transfer including Complexity and Risk Factors, The importance of communication, Optimising the transfer programme
- Session 4: Workshop Case Study and Group Activity
Who Should Attend?
Process Development Scientists/Engineers
Manufacturing Operations Managers
Quality Assurance/Quality Control Managers
Regulatory Affairs Professionals
Project Managers
Supply Chain Managers
Analytical Development Scientists/Engineers
Validation Specialists
Operations and Production Personnel
Research and Development Scientists
Business Development Managers
- Thomas Chattaway - Senior Life Science Consultant, Independent
This workshop will explore the current initiatives, innovative strategies and new technologies designed to drive sustainability of biologics process development and manufacturing.
- Define the Current State of Sustainability in 2024
- Case Studies on Current Initiatives from End Users and Vendors
- Help Individuals develop sustainability strategies and solutions best suited for their companies
- Interactive Discussions on Challenges with Single Use and Environmental and Economic Modeling
- A Look Ahead - What’s Next and What’s Needed?
- James Dean Vogel - Founder and Director , The BioProcess Institute
*This event requires a separate ticket which can be purchased at a discount during your conference registration*
The BWB Awards @ Biotech Week Boston brings together the faces and names that make the Boston community the beating heart of the biotech world.
This evening celebratory gala features a night of networking, food, drink, entertainment and recognition on September 23rd, 2024 in Boston. We're excited to roll out the red carpet and honor the top individuals, teams, and organizations that make the life sciences ecosystem vibrant and innovative.
Full details on the BWB Awards 2024 can be found at https://informaconnect.com/bwb-awards/