Biomanufacturing Summit 2009

January 27-28, 2009

Hyatt San Diego, California

day one | day two

Day OneJanuary 27, 2009
07:00
Delegate Registration and Morning Refreshments
08:00
Chairperson's Welcome Address

Laura Bush, Editor in Chief , Biopharm International ,
08:10
RAISING THE BAR IN THE BIOPHARMACEUTICAL INDUSTRY: HOW EFFECTIVE LEADERSHIP AND INNOVATION CAN HELP YOU BECOME A BEST IN CLASS BIOPHARMACEUTICAL ENTERPRISE AND MAINTAIN PROFITABILITY IN UNCERTAIN TIMES
Case Studies from Genentech
  • Review biotechnology trends and future global capacity and learn based on case studies of Genentech’s recent engineering projects and lessons learned
  • Understand the real world challenges of the biopharmaceutical business and the importance of leadership
  • Evaluate bioprocess innovations and trends based on case study examples

Dr. Pat Yang, EVP Product Operations, Genentech ,
08:50
CURRENT DEMANDS AND FUTURE REQUIREMENTS: DEVELOPING INNOVATIVE STRATEGIES TO CREATE THE FLEXIBLE FACILITY OF THE FUTURE AND UNCOVER HIDDEN CAPACITY
Understand how you can plan for unpredictability in market demand!
  • Determine how you can establish an effective multi product facility and develop tactics to overcome the challenge of campaign turnover efficiency and cleaning validation
  • Learn how you can design in variability of market and capacity demand to achieve maximum utilization of your facility
  • Forecasting high titer processes and how strategic facility planning can help you avoid a capacity crunch downstream
  • Identify the role disposables will play in creating facility flexibility and assess what role they will play in your next facility build
  • Assess future build do's and don’ts and how this can be applied to ensure optimal facility utilization

Dr. Michael D. Kowolenko, SVP, Technical Operations and Product Supply (TO+PS), Wyeth Biotech ,
09:30
Pre-Arranged One to One Meetings & Networking Coffee Break
Accelerate the networking process by taking one-to-one meetings with fellow delegates and leading solution providers
10:50
POST APPROVAL PROCESS AND SCALE CHANGES: WINNING STRATEGIES TO ENSURE PRODUCT COMPARABILITY
  • understand what strategies and technologies you can use to bring your products from bench to commercialization
  • determine how developing a sound scientific understanding of your product design space can help in relieving regulatory pressures for post-approval changes
  • learn how to develop a successful comparability protocol strategy to ensure success of your scale up venture
  • identify lessons learned during post approval process or scale changes and how this can help ensure you maintain product comparability

Dr. John K Towns, Director, Global CMC Regulatory Affairs , Eli Lilly ,
11:30
INTERACTIVE WORKSHOP
Ceramic Hydroxyapatite: A powerful polishing chromatographic media for monoclonal antibody production.
  • Evaluate Ceramic Hydroxyapatite as an emerging platform technology for the polishing of monoclonal antibodies.
  • Discuss how CHT™ Ceramic Hydroxyapatite provides orders of magnitude clearance for host cell proteins, viruses, DNA and leached protein A.
  • Learn from case study data based on several monoclonal antibody purifications
  • Discuss one of the most powerful aspects of CHT, the ability to remove aggregates

Dr. Mark Snyder, Manager, Process R&D Applications Group , Bio-Rad ,
 
INTERACTIVE WORKSHOP
Advances in Single Use Capture Chromatography
  • Evaluate Natrix Separations newly developed high performance membrane-based single use capture chromatography technology which provides users with further options for the implementation of single use systems in their bioprocesses
  • discussing applications for single use capture chromatography technology with an emphasis on the interplay between applications, product format and membrane chemistries.
  • Benefits of disposables: disposable buffer bags, tubing, aseptic connectors, and viral clearance filters have demonstrated their value vs conventional reusable technologies by reducing the risk of batch-to-batch contamination, eliminating the need for cleaning and storage validation and reducing the down-time associated with product changeover.

Chris Shields, Vice President Marketing & Applications Development, Natrix Separations, Inc. ,
 
12:05
HOSTED LUNCHEON
13:15
INTERACTIVE WORKSHOP
MAXIMIZING FERMENTATION YIELDS: HOW YOU CAN UTILIZE PAT AND QBD TO DEVELOP A DEEP UNDERSTANDING OF YOUR PROCESS
  • determine which critical parameters influence fermentation and how you can change these parameters to achieve improvement in Quality by Design efforts
  • define the key requirements for real time (online) monitoring, categorize different classes of analytical instruments and sensors and determine how this will impact the data management concept
  • Learn, based on case study, how to identify critical parameters and develop a draft of a ROI analysis of PAT/QbD project in biological production (antibody)
  • Discuss global data integration, harmonization and unit to unit comparability as well as experiences with existing solutions of PAT and QbD projects.

Andreas Schneider, Director Global Sales , Innovatis AG ,
 
INTERACTIVE WORKSHOP
Achieving the Goals of QbD and PAT – Bridging the Gap between Process Development and Manufacturing
  • Understanding that the critical success factor for achieving the goals of QbD is access to all the process data for end users in process development and manufacturing in a collaborative investigational analytics, trending and reporting environment.
  • Determine how these requirements, a single user-centric interface for direct access to all the data in context from disparate sources including paper record, and automatic accounting of batch genealogy to enable upstream/downstream correlations , can be satisfied with the technologies readily available today
  • Key discussion points inlude: Quality by Design (QbD) starts in process development, Business benefits and user requirements for QbD, Tools for achieving QbD in pharmaceutical processes, On-demand data access for QbD collaboration, Electronic and paper-based data, Using on-line and off-line data together for analysis, Multi-disciplinary collaborative analytics environment, Leveling geographic and departmental barriers

Dr Justin Neway, Chief Scientific Officer, Aegis Analytical ,
 
13:50
INTERACTIVE WORKSHOP
Innovatis Workshop Continued
 
INTERACTIVE WORKSHOP
Aegis Analytical Workshop Continued
 
14:15
UPGRADING LEAN MANUFACTURING TO CREATE A ROBUST AND HIGHLY PRODUCTIVE BIOMANUFACTURING PROCESS
How Lean Manufacturing can help you maintain efficiency in uncertain economic times
  • Implementing Lean principles to biomanufacturing, to accelerate changeover, increase throughput rate and reduce throughput time
  • Learn from case studies how to manage Lean projects in practice
  • Assess the impacts and benefits (ROI) of Lean on plant capacity, flexibility and COGs
  • Understand how to adapt the plant organisational structure to support a culture of continuous improvement
  • Develop strategies to move beyond lean: next steps towards Operational Excellence

Dr. Thibaud Stoll, Head of Global Biopharmaceutical Operations, Novartis Pharma AG ,
15:05
Pre-arranged One to One Meetings & Networking Coffee Break
Accelerate the networking process by taking one-to-one meetings with fellow delegates and leading solution providers
16:40
DECISION-SUPPORT TOOLS FOR OPTIMIZING THE ECONOMICS OF BIOPHARMACEUTICAL PURIFICATION STRATEGIES
  • Assess the impact of scale and titre on critical purification economic drivers
  • Learn how to explore the balance between striving for improved operational efficiencies and the subsequent implications on cost, time and risk
  • Establish how to reconcile multiple operational and financial trade-offs when using disposable technology for downstream processing
  • Understand how you can capture the impact of titre variability on the robustness of chromatography configurations
  • Identify factors contributing to the breaking point of existing facilities as titres increase

Dr Suzanne S. Farid, Associate Professor, The Advanced Centre for Biochemical Engineering, University College London ,
17:20
DEVELOPING THE PLATFORM OF THE FUTURE: IMPLEMENTING A FULLY DISPOSABLE CELL CULTURE PLATFORM CAPABLE OF MAKING CLINICAL AND COMMERCIAL SUPPLIES
Case Study: Utilizing disposable 1000L bioreactors in development and cGMP manufacturing
  • Determine how you can take advantage of the increase in process yields and new technologies like disposables to develop more modular and compact facilities
  • Evaluating the entire platform encompassing media, harvest storage, cell expansion in seed bioreactors and production bioreactors
  • Discover how this platform may increase the capability of disposable bioreactors for further production using a highly compact and cost effective manufacturing facility
  • Uncover the design, implementation and regulatory challenges for the disposable platform and how this may change the future of cell culture processes

Dr. Sadettin Ozturk, Head Bioprocessing Technology, Centocor ,
18:00
FORECASTING THE ARRIVAL OF BIOGENERICS AND WHAT YOU CAN DO TO ENSURE YOU MAINTAIN YOUR COMPETITIVE ADVANTAGE
  • Understand the regulations in place for the approval of generic biologics and what role regulatory bodies will have in ensuring biological equivalency, safety and efficacy
  • The EU has set guidelines for producing biogenerics. Learn what role will this play in developing US policy and what this mean for the timeline of generic market entry in the US
  • Develop tactics to continue to manufacture and sell competitive products in an increasingly hostile environment
  • Identify the methods you can use to successfully navigate the changing competitive landscape

William Haddad, Chairman & CEO , Biogenerics Inc ,
18:40
Networking Drinks Reception

day one | day two

Day TwoJanuary 28, 2009
07:30
Delegate Registration and Morning Refreshments
08:00
Chairperson's Opening Remarks

Laura Bush, Editor in Chief , Biopharm International ,
08:10
THE THIRD WASTEFUL SIN: STRATEGIES FOR REDUCING PROCESS VARIATION AND CREATING AN EFFICIENT BIOPHARMACEUTICAL OPERATION
Case Study: Proven and Practical means to drive accessible variation out of your process !
  • Define Variation- what is it? Where is it ? What impact does it have and how do we fix it?
  • Discover based on a practical case study example how to reduce variation and continue to deliver throughput
  • Analyze the benefits of value streams in determining critical variation
  • Ascertain how you can develop strategies to address variation beyond QbD or PAT with the resources you already have at your disposal.

William Botha, Director Manufacturing, Baxter Healthcare ,
08:50
THE EVOLUTION OF QBD IN BIOPHARMACEUTICAL PRODUCTION: STRATEGIES FOR UTILIZING QBD CONCEPTS TO MOVE BEYOND PROCESS ROBUSTNESS
  • Develop strategies to achieve organizational buy in of your QbD program by having an in-depth understanding of the QbD principle
  • Identify the limitations for the QbD principle in biologics and understand how far it can be taken
  • Assess the benefits and determine the potential ROI of QbD and how this can fit into your company’s overall business strategy
  • Identify whether data generated from design space studies will lead to relief of regulatory scrutiny
  • Highlighting how you can take the risk based approach to defining the critical quality attributes for your product

Rohin Mhatre, Director Bioprocess Development, Biogen ,
09:30
QbD: FUNDAMENTAL CONCEPTS FOR IMPLEMENTATION
IMPLEMENTING QBD: WINNING METHODS FOR IDENTIFYING CRITICAL QUALITY ATTRIBUTES AND DEFINING THE DESIGN SPACE
  • Uncover the latest knowledge on how to fully characterize biologics in order to move forward your QbD process
  • Assess the steps and considerations needed to be taken before submitting your design space BLA (biologic licensee application)
  • Develop a sound scientific understanding of how you should implement QbD to ensure you achieve the desired outcome first time around
  • Understand how to use design of experiments (DOE), small scale studies and response surface mapping to define the design space and gain greater knowledge of critical process parameters

Dr. Ron Taticek, Associate Director CMC Regulatory Affairs, Genentech ,
 
INTERACTIVE WORKSHOP
Reducing the Downstream Bottleneck:Evaluating and discussing high productivity purification technologies
Millipore’s Solution for Downstream MAB Purification
Millipore
  • Highlighting technologies that can significantly de-bottleneck downstream purification of commercial scale MAb processes and overcome the processing challenge of downstream purification of MAbs.
  • Discuss technologies including: clarification, capture chromatography, parvovirus clearance, protein concentration-diafiltration, and sterile filtration operations

Edward Graham-Brown , Vice President of Strategic Marketing, Bioprocess Division, Millipore ,

Fred Mann , Program Manager – Downstream Purification Solutions, Millipore ,
 
10:05
Morning Refreshments & Networking Break
10:40
ADVANCING THE PRINCIPLES OF QBD: YOUR QUESTIONS ANSWERED TO ENSURE ORGANIZATIONAL BUY-IN OF YOUR QBD INITIATIVE
Panel Discussion
  • Determine the differences in applying QbD to new vs. currently commercialized molecules
  • What is the predicted future use of Qbd? Will it really provide the regulatory flexibility that is expected?
  • What role does PAT play in the broader QbD landscape?
  • Identify what the barriers to acceptance are within an organization and the strategies you can use to overcome them

Dr. Ron Taticek, Associate Director CMC Regulatory Affairs, Genentech ,
Dr. John K Towns, Director, Global CMC Regulatory Affairs , Eli Lilly ,
11:15
FUTURE DIRECTIONS IN SINGLE-USE MANUFACTURING - MEETING REGULATORY REQUIREMENTS, ASSESSING ENVIRONMENTAL IMPACT AND ENSURING EFFECTIVE SUPPLIER PARTNERSHIPS
BPSA

  • Understand the current regulatory view on implementation and validation of single use process components and systems.
  • Disposing of disposables - How do you integrate sustainability initiatives with disposable technology to ensure a ‘greener’ process?
  • Establish productive user/supplier relationships for single-use system development and inventory management.
  • Staying ahead - External resources for new technologies and best practices

Jerold Martin , SVP Scientific Affairs , Pall Life Sciences & Chairman , BioProcess Systems Alliance ,
12:00
THEMED LUNCHEON DISCUSSIONS
Topics highlighted below
12:00
Outdated facility not meeting cGMP Regulations? Are you building a new clean room? Have lunch with HWI and discuss how we can help you with these situations
Led By: Haddad-Wylie Industries
 
Developing a lean, robust chemical supply chain
Led By: Doe & Ingalls of North Carolina
 
Technology Transfer: More than Documentation
Led By : Cytovance
 
13:10
THE TALE OF TWO MANUFACTURING PLATFORMS: KEY CONSIDERATIONS FOR MAKING A PLATFORM WORK FOR YOU
  • Highlighting the benefits of a manufacturing platform and the limitations which make biologics less amenable to a “true” manufacturing platform
  • Identify key technologies to incorporate into your platform, highlighting case studies from two distinctively different, yet remarkably similar platforms: large volume MAbs and small volume enzymes
  • Provide a glimpse into the future on how manufacturing platforms will need to evolve as our industry evolves

Dr. Andrew Ramelmeier, VP Manufacturing & Process Development, BioMarin Pharmaceuticals ,
13:50
BEST PRACTICES IN TECH TRANSFER MANAGEMENT: PREPARING FOR A TECH TRANSFER - A RECEIVING SITE PERSPECTIVE
A case study for a technology transfer of a biologic process and elucidate the perspectives, business processes, actions and critical success factors for the transfer
  • Learn, through case study, the systematic series of activities that occurs with a technology transfer for a new product or process introduction at a receiving commercial manufacturing site
  • Determine how to create a repeatable, predictable and cost-effective transfer by setting a predefined business process for technology transfer with appropriate transfer stages, approval gates, requirements to be met at each gate, and roles and responsibilities
  • Evaluate the activities required for tech transfer ranging from a highly detailed evaluation of process requirements against the facility capabilities to evaluation of permits to comply with local regulations

Dr. Sourav Kundu, Associate Director for Process and Clinical Operations , Amgen ,