Monday, September 23, 2024 - Pre-Conference Day - ET (Eastern Time, GMT-05:00)
Monday, September 23, 2024 - Pre-Conference Day - ET (Eastern Time, GMT-05:00)
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
- Developing formulations that enhance the stability of biologics
- Include the use of excipients, lyophilization, and novel delivery systems
- Case study on challenges with formulating high concentration biologics – particularly emerging biologics
- Improve viscosity to avoid issues with syringe ability and injectability - development of specialized delivery devices
- Optimising buffer systems and excipient usage
- Maintaining homogeneity
- Storage and temperature challenges
Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. They are introduced to the market at a lower price thereby enabling more patients to get treatment and to lower the medical treatment costs for society. I will share knowledge about some new techniques to enhance productivity whilst maintaining quality which is key to be able to successfully develop a biosimilar.
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
- Analytical technologies and testing techniques for early detection and prevention of aggregation in the formulation?
- Developing predictive models for looking at aggregation
- Doing a Lot With A Little: Formulation Studies on Low Product Volumes
- What to expect?
- Common pitfalls
- Approaches for efficient and consistent process development
- Case studies on Process Development challenges and Manufacturing scale up
- Overview and compoenents of next generation manufacturing
- Use of AI/ML assisted with QbD and PAT and its advantages
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
Examples of methods that are sensitive, specific, and capable of detecting minor differences between the biosimilar and the reference product.
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
- Example of inline mixing or real-time monitoring with process control strategies for product quality
- Non-Invasive Analytical Methods for Liquid Formulations To Reduce Contamination
- Using closed systems for sterility assurance and lack of contamination
- How to validate the process for regulatory requirements?
- Utilizing digital twin technology to simulate and optimize formulation and fill/finish processes, improving efficiency and reducing the risk of errors
- Leveraging AI and machine learning to predict formulation stability, optimize process parameters, and ensure consistent product quality
- What encapsulation techniques can prevent enzymatic degradation by stomach acid?
- Co-formulation techniques with molecules that can assist in absorption?
- How to maintain stability in the GI tract?
Although many new bioprocessing technologies have evolved over the past 40 years, biosimilars still tend to be made using their legacy production processes. However, the ability to precisely evaluate critical quality attributes in finished drug substances has also evolved. This capability can provide a pathway for adopting powerful new upstream and downstream production methods, where drug impacts can be controlled.
- 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?
*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/