Monday, September 23, 2024 - Pre-Conference Workshops - ET (Eastern Time, GMT-05:00)
- David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University
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.
- David Vikström - CTO, Xbrane Biopharma
- Justin Stebbing, PhD - Professor of Biomedical Sciences, Anglia Ruskin University
- Eden Turner - Portfolio Manager, Informa Connect
- Lottie Leinfellner - Senior Conference Producer, Informa Connect
- Eeshit Vaishnav - CEO, Sequome
- Yanling Wang - Sr. Director of Synthetic Biology, Protein Expression, Henlius
The increasing structural complexity of recent therapeutic proteins presents a multitude of challenges during development and production. One such challenge is protease-mediated proteolytic cleavage which can lead to immunogenicity, as well as reduced efficacy and protein stability. During the manufacturability assessment of both, an IL12-Fc fusion and another non-mAb molecule (molecule N), we detected clipping variants due to activity of the serine-protease Matriptase-1. In this study, we evaluated the feasibility of overexpressing the Matriptase-1 inhibitor, HAI-1 and its variants to reduce the level of clipping for both programs.
Co-expression of HAI-1, soluble HAI-1, or chimeric versions of HAI-1 effectively reduced the clipping levels of IL12-Fc and molecule N without adverse impacts on productivity and critical quality attributes (CQAs) except for IL12-Fc’s titer during fed-batch expression from stable pools. Full-length HAI-1 performed the best among the inhibitors.
Full-length HAI-1 was then co-expressed in three molecule N clones exhibiting various clipping levels. One clone showed significantly lower Matriptase-1 activity (~16%) and the lowest clipping level (3.2% versus 12% and 15%) at day 12 of Fed-Batch. The co-expression of HAI-1 inhibited Matriptase-1 activity in all three clones during the initial seven days of the Fed-Batch process, with continued inhibition up to twelve days in one clone. Clipping levels were correspondingly reduced with HAI-1 co-expression in these clones at day 7, 10 and 12 of fed-batch, with 35%-90% reduced clipping observed compared to control strains.
In conclusion, the co-expression of Matriptase-1 inhibitor HAI-1 in CHO cell pools and clones of IL12-Fc and molecule N successfully decreased proteolytic cleavage levels during the fed-batch production process without adverse effects on the quality attributes of the proteins. This presents a novel, cost-effective and scalable approach to mitigate recombinant protein cleavage in CHO cell culture.
- Qinghao Zhang - Senior Scientist, Process Cell Sciences, Merck & Co., Inc.
- Eden Turner - Portfolio Manager, Informa Connect
- Lottie Leinfellner - Senior Conference Producer, Informa Connect
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, 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, Consultant
- James Dean Vogel - Founder and Director , The BioProcess Institute
- Sonia Schwantes, MBA - Director, Product & Innovation, NewAge AdvantaPure
- Chad Waites - Sales Manager LifeScience, Rychiger AG
Developing low-volume high-dose biologic drugs for subcutaneous injection often requires high-concentration formulations and optimizing viscosity, solubility, and stability while overcoming analytical, manufacturing, and administration challenges. To understand industry approaches for developing high-concentration formulations, the Formulation Workstream of the BioPhorum Development Group, an industry-wide consortium, conducted an inter-company collaborative exercise through a comprehensive survey that provides an industry perspective, experience, and insight into the practicalities for developing high-concentration biologics.
- Preeti Desai - Senior Principal Scientist, Sterile Product Development, Bristol Myers Squibb
- How to avoid contamination?
- Ensuring minimal product waste while preserving the integrity of the biologics
- Ensuring smooth transitions from early-stage development to high-volume manufacturing
- Innovations in Automation
- Chad Waites - Sales Manager LifeScience, Rychiger AG
- Slobodanka (Dina) Manceva - Associate Director, Drug Product and Technology Development, Teva Branded Pharmaceuticals
- What to expect?
- Common pitfalls
- Navigating the patent landscape for biosimilars, including patent challenges and litigation strategies
- Developing effective IP strategies to protect biosimilar products and processes
- Charles Andres - Shareholder, Greenberg Traurig
- 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
- 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
- Ken Baker - Senior Director, External Manufacturing, Fusion Pharmaceuticals
This presentation explores spinal cord injury (SCI) treatment by comparing AbbVie's Elezanumab, a monoclonal antibody-based therapy in clinical phase, with NurExone's innovative treatment utilizing extracellular vesicles (EVs) and small interfering RNA (siRNA). Through a comparative analysis, we investigate the potential impact, efficacy, and advancements offered by these distinct modalities in transforming SCI management. Join the talk to uncover the intricacies of these cutting-edge therapies and their implications for the future of spinal cord injury treatment.
- Lior Shaltiel - CEO, NurExone Biologic
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, 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, Consultant
- Magali Barbaroux - Corporate Research, Sartorius
- Magali Barbaroux - Corporate Research, Sartorius
- Mark Yang, PhD - VP of CMC, Palleon Pharmaceuticals
The talk covers recent work aimed at establishing an understanding of fogging in freeze-dried (lyophilized) products. The severity of fogging in lyophilized products is impacted by a varied range of factors - formulation composition, pharmaceutical processing conditions and primary packaging. Hence, a systematic study to investigate the influence of each of these factors on fogging will enable a mechanistic understanding and consequently, the design of suitable mitigation strategies.
- Navpreet Kaur - Scientist, Biologics Drug Product Development, Sanofi
Meet at Hynes Convention Center at 12:30pm for transport to the site tour
RSVP to join the Resilience team for a tour of our Technical Development Center and Manufacturing facility in Boston. This event is free-to-attend but all registrations are subject to review by the Resilience team.
Receive an inside look of our commercially licensed facility featuring:
- Process and analytical development labs for viral vectors, mAbs, and recombinant proteins
- Upstream and downstream manufacturing areas with state-of-the-art drug substance development and continuous manufacturing capabilities, including our 4x 2KL single-use and 6x 2KL stainless bioreactors supporting a variety of product types and scale-up needs
- High-throughput process and analytical work systems to support upstream and downstream development, including CHO fed batch and perfusion development
- Cell culture, harvest, downstream, and segregated pre and post viral production areas
During the tour, you’ll also have an opportunity to interact directly with the team who works tirelessly to integrate our technical capabilities with manufacturing, enhancing our ability to bring life-changing therapies to patients faster and more efficiently.
When: September 23, 1:00 pm – 4:00 pm
Where: 500 Soldiers Field Rd, Allston, MA 02134, USA
Agenda:
- Welcome message from Resilience leadership
- Tour of facility
- Refreshments and networking
- Opportunity to connect with Resilience technical and scientific experts
We look forward to seeing you there!
Examples of methods that are sensitive, specific, and capable of detecting minor differences between the biosimilar and the reference product.
- Alla Polozova - Director, Process Development, Amgen
When I joined BioFactura over a decade ago, the biosimilar landscape was relatively unknown, yet cautiously optimistic. It was a good environment to raise adequate capital from high net worth individuals to begin the process of clone selection and process optimization for our first biosimilar candidate. As the company grew, along with the financial commitments for clinical trials, and the potential returns of biosimilar investment seemed less encouraging, one had to think out of the box in order to see our first asset successfully partnered. This talk will chronicle that journey and hopefully spark your own entrepreneurial spirit to see your therapeutics over the finish line!
- Jeffrey Hausfeld - Chairman of the Board, Biofactura
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.
- David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
- Potential of emerging modalities: the promise and potential novel therapeutics for the improved treatment outcomes, targeted delivery, and stability
- How will the difficulties in the manufacturing of these modalities be overcome with next-generation strategies and technologies
- Lessons we can learn from 'traditional' modalities to apply to emerging classes of therapeutics
- Strategies for navigating regulatory pathways and ensuring timely approvals when working with novel products
- Clinical development & adoption: hurdles around designing trials for novel therapeutics, and educating healthcare providers on benefits to encourage adoption
- Eeshit Vaishnav - CEO, Sequome
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
- Lior Shaltiel - CEO, NurExone Biologic
- Ken Baker - Senior Director, External Manufacturing, Fusion Pharmaceuticals
- Yanling Wang - Sr. Director of Synthetic Biology, Protein Expression, Henlius
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, 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, Consultant
- Robert Barrentine - Sustainability Project Manager, Saint-Gobain
- James Dean Vogel - Founder and Director , The BioProcess Institute
- Brian Gregory Youchak - Sr. Advisor, Eli Lilly and Company
- Sonia Schwantes, MBA - Director, Product & Innovation, NewAge AdvantaPure
- Robert Barrentine - Sustainability Project Manager, Saint-Gobain
- James Dean Vogel - Founder and Director , The BioProcess Institute
One of the therapies which hold enormous potential for treating many terminal diseases includes protein-based therapies. Yet, the lack of universal technological approaches that enable the development of protein formulations with targeted attributes, blocks the clinical translation of these advanced therapies. This presentation explores and highlights a droplet-based microfluidic technology as an advanced platform for a streamlined screening and optimization of biotherapeutic formulations.
- Sabiruddin Mirza, PhD (Pharm.) - Senior Research Fellow, School of Engineering & Applied Sciences Harvard University
- Carl Mieczkowski - Consultant, Allostery Consulting
- Christina Vessely - Senior Consultant, Biologics Consulting
Meet at Hynes Convention Center at 12:30pm for transport to the site tour
RSVP to join the Resilience team for a tour of our Technical Development Center and Manufacturing facility in Boston. This event is free-to-attend but all registrations are subject to review by the Resilience team.
Receive an inside look of our commercially licensed facility featuring:
- Process and analytical development labs for viral vectors, mAbs, and recombinant proteins
- Upstream and downstream manufacturing areas with state-of-the-art drug substance development and continuous manufacturing capabilities, including our 4x 2KL single-use and 6x 2KL stainless bioreactors supporting a variety of product types and scale-up needs
- High-throughput process and analytical work systems to support upstream and downstream development, including CHO fed batch and perfusion development
- Cell culture, harvest, downstream, and segregated pre and post viral production areas
During the tour, you’ll also have an opportunity to interact directly with the team who works tirelessly to integrate our technical capabilities with manufacturing, enhancing our ability to bring life-changing therapies to patients faster and more efficiently.
When: September 23, 1:00 pm – 4:00 pm
Where: 500 Soldiers Field Rd, Allston, MA 02134, USA
Agenda:
- Welcome message from Resilience leadership
- Tour of facility
- Refreshments and networking
- Opportunity to connect with Resilience technical and scientific experts
We look forward to seeing you there!
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, 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, Consultant
- Yogapriya Murugesan - Scientist I, Biogen
- James Kranz - VP and Head of CMC, Compass Therapeutics
- At what stage of development do you determine the final dosage format?
- Lyo vs liquid and Vial vs pre-filled syringe
- What drives high concentration development?
- What stage do you initiate development?
- When is it too late to make these decisions?
- Selecting an appropriate sterility or container closure integrity method
- Strategies of selecting your fill-finish vendor
- What formulations are being developed for bispecifics and ADCs?
- Are people using traditional approaches or predictive modeling for formulation selection or development?
- How to ensure stability throughout shelf life, to prevent degradation, aggregation, and denaturation?
- Preeti Desai - Senior Principal Scientist, Sterile Product Development, Bristol Myers Squibb
- Christina Vessely - Senior Consultant, Biologics Consulting
- Sabiruddin Mirza, PhD (Pharm.) - Senior Research Fellow, School of Engineering & Applied Sciences Harvard University
- Yogapriya Murugesan - Scientist I, Biogen
- James Kranz - VP and Head of CMC, Compass Therapeutics
Meet at Hynes Convention Center at 12:30pm for transport to the site tour
RSVP to join the Resilience team for a tour of our Technical Development Center and Manufacturing facility in Boston. This event is free-to-attend but all registrations are subject to review by the Resilience team.
Receive an inside look of our commercially licensed facility featuring:
- Process and analytical development labs for viral vectors, mAbs, and recombinant proteins
- Upstream and downstream manufacturing areas with state-of-the-art drug substance development and continuous manufacturing capabilities, including our 4x 2KL single-use and 6x 2KL stainless bioreactors supporting a variety of product types and scale-up needs
- High-throughput process and analytical work systems to support upstream and downstream development, including CHO fed batch and perfusion development
- Cell culture, harvest, downstream, and segregated pre and post viral production areas
During the tour, you’ll also have an opportunity to interact directly with the team who works tirelessly to integrate our technical capabilities with manufacturing, enhancing our ability to bring life-changing therapies to patients faster and more efficiently.
When: September 23, 1:00 pm – 4:00 pm
Where: 500 Soldiers Field Rd, Allston, MA 02134, USA
Agenda:
- Welcome message from Resilience leadership
- Tour of facility
- Refreshments and networking
- Opportunity to connect with Resilience technical and scientific experts
We look forward to seeing you there!
*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/