2012 Conference Program
Program - Day One30th January 2012
Bernie Huyghe, Ph.D., RAC
Sr. Director, External Supply. Pharmaceutical Sciences, Biotherapeutics & Vaccines Outsourcing, Worldwide Research & Development
Pfizer USA
What can we look forward to ?
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- Biosimilars. Evaluating the preferred path, security of market and considerations of cost and complications.
- Challenges in supply and sourcing. Keeping up with a complex global supply chain.
- Managing capacity across global operations
Joerg Heidrich
S.V.P., Head of Global Product Supply Biotech, and Site Head - Berkeley
Bayer Healthcare Pharmaceuticals
Has the relentless drive to reduce cost in our industry blurred our necessary focus on quality?
- We should never issue general financial targets : “Reduce COGM by 3%"
- We should understand all elements of cost and identify specific targets
- There will be a cost threshold below which we should not go
- A Case Study
- We are not making sneakers in these plants
EXPEDITING PRODUCT DEVELOPMENT: Facility Fit, Scale-up and Analytical Lifecycle
Examining the evolving strategies necessary for rapid tech transfer and scale-up.
- Relying on rapid analytics to drive product and process development
- Coping with the inevitable environment of time constraints
- Ensuring error-free tech transfer and scale-up
- Employing innovative technologies to bring molecules through clinical and commercial development
COLLABORATION MODELS: Optimizing CMO relationships
Ensuring alignment in quality and compliance expectations
- Reduction and control of complexity
- Achieving flexibility and predictability
- Total cost reduction
- Resolving cultural gaps
Reducing Technology Transfer Risk Using a Collaborative Process Intelligence Platform
- Minimizing tech transfer risks within organizations and between remote organizations.
- Use of collaborative, self-service data access, aggregation, contextualization and analytics
- Utilizing a reporting platform that spans local and geographically remote process development, quality assurance and manufacturing operations.
STRATEGIES IN EFFECTIVE TECHNOLOGY TRANSFER
Establishing an error-proof system in internal and external tech transfer
- Right Actions at the Right Time
- Operational Excellence through Documentation and Business Systems
- Tech transfer evolution to risk based Control Strategy
Supporting market development by licensing out manufacturing steps
Best-in-Class strategies to ensure product quality, continued supply and a successful partnership
- Making sense of the business environment: establishing a clear understanding of responsibilities of Licensor and Licensee
- Effective partner selection: Timelines for setting up partnership, transfer of know-how
- Setup and maintenance of overview and contacts
- Avoiding typical pitfalls: taking proactive steps to mitigate risk
IMPLEMENTING QBD IN YOUR ORGANIZATION
A practical look at QbD
- Developing a QbD vision for a Biotech organization
- Getting buy in and developing a plan to implement
- Some key tools and approaches to drive greater process knowledge and control
INSTRUMENTATION FOR FERMENTATION ANALYSIS
- low variability in metabolic and nutrient profiles
- at-line determination of product titers
- identify factors connected to product quality
- Meet these current requirements and enable accurate and reliable fermentation analytics within one tool.
LEAN SIX SIGMA WORKS IN THE BIOLOGICS SITUATION
- Increased Throughput
- Improved quality and process stability
- Customer focused solutions
- Manufacturing competitiveness on a global level
DEMYSTIFYING RAPID METHODS IN QUALITY CONTROL
- The benefits of Rapid Detection to QC and Manufacturing
- The importance of being non-destructive
- Key areas of value to build a business case
BUILDING AND RETAINING THE BIOLOGICS DREAM TEAM
- Manufacturers must focus on improving quality and fulfillment while at the same time, reducing cost of goods. These strategies often emphasize Total Quality, discovery effectiveness, manufacturing consolidation and outsourcing. In this execution based environment, personnel development and retention of key talent is paramount to effectively implement these initiatives.
- A CASE-STUDY looking at how change programs affect personnel and the emergence of successful developmental and retention strategies.
INSOURCING - A CASE STUDY
Strategies to increase capacity utilization within existing facilities
- Review some considerations and motivation - in-sourcing or out-sourcing
- Examine strategies for enabling in-sourcing
- Case studies
- Tech Transfer
- Continuous Improvement
MANAGING QUALITY ON A GLOBAL SCALE
Q10 International Harmonization Guidelines- WHAT DOES IT MEAN AND HOW CAN IT HELP ?
Pierre-Alain Ruffieux
Head Global Manufacturing & Biologics Quality Assurance
Novartis Pharma AG Basel, Switzerland.
MIT CBI Biopharmaceutical Manufacturing Site Survey
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- In-depth view of site-specific quality activities and perceptions
- Site-level reported drivers of past and future change in quality activities
- Analysis of lifecycle characteristics statistically related to product-specific quality performance including role of development regions globally, region of manufacture and use of contract manufacturers
Program - Day Two31st January 2012
Bernie Huyghe, Ph.D., RAC
Sr. Director, External Supply. Pharmaceutical Sciences, Biotherapeutics & Vaccines Outsourcing, Worldwide Research & Development
Pfizer USA
- The challenges of capital investment and capacity management in biotechnology
- Technological advances & biosimilars: catalyst for a new approach to capacity management
- Hedging portfolio risk through capacity sharing
- A Case Study: Merck/MedImmune Network
- Factors to establishing a successful agreement/partnership
- How different is biomanufacturing compared to other industries with respect to capacity management and product differentiation?
What does excellence mean and where are we going?
Multi disciplinary perspectives from manufacturing, supply chain, quality, and regulatory
- Internal and external excellence – best practices in supplier management both internally and externally
- Maintaining the relationship – moving beyond communication to collaboration – taking supplier relationships to the next level of excellence
- Implications of FDA’s zero defect initiative – instilling a total enterprise quality mindset
- EMERGING MARKETS - quality risk management considerations that should be a top priority
Andrew Knudten
Sr. Director & Global Head of Contract Manufacturing and Strategy
Novartis Vaccines and Diagnostics, Technical Operations USA
“Analysis of Upstream Cost of Goods”
Challenges and cost pressures in the industry are forcing many to explore new production options away from the traditional fed-batch. Increasingly popular is the application of the ATF™ System to generate ultra high viable cell concentrations (>100m cells/ml) for a “concentrated” or “intensified” process.
- Generating a protein titer of 17g/L in a CHO cell line. - Examples of the use of the ATF System in a typical concentrated fed-batch process
- Examination of cost of goods and the economic feasibility of manufacturing a typical glycosylated protein in a single reactor train using three production techniques – fed-batch (FB) - concentrated fed-batch (CFB) and - concentrated perfusion (CP).
- Outfitting a “Factory of the Future.”- A possible major intensification of the whole upstream process
Managing risk in the supply chain
practical fail-safe strategies to ensure robust and secure supply chain operations
- Aligning manufacturing and supply
- Demand management and forecasting
- Establishing the metrics: systems to provide feedback on supply chain health and/or risk
From A Snail's Pace to Real-Time: Transforming Biopharmaceutical Operations
Biopharmaceutical manufacturing is unique in its level of operational variability and simultaneous need for high service levels. This approach necessitates a different paradigm to designing, scheduling and responding to the changing needs of manufacturing facilities. We outline how this has been implemented in a series of case studies from major biomanufacturers that focus on:
- How real-time data has been used to enable robust process monitoring and control (ICH Q10)
- How real-time scheduling can instantly respond to changing plant conditions
- How real-time models can show changing bottlenecks and optimize patterns of use
The roles of Manufacturing Organizations have become increasingly complex as companies grow, merge, acquire and rely on each other for supply of Biologics- This presentation offers an in depth look through case studies showing successful strategies and outlined obstacles that must be overcome to meet the needs of an organization
- Establishing complex supply channels, even in the smallest Biotech companies, to support clinical development and future commercial production
- The lack of available capital for emerging Biotechnology companies has forced a new level of creativity to ensure product is available. This condition has spawned new technology and increased cooperation in sharing existing capacity.
- Large and mid-size Biotech may have the opposite problem; finding opportunities to ensure capacity and manufacturing assets are utilized.
- Bioreactors – rockers, stirred tank, scale-up
- Mixers – on demand media and buffer prep
- Precision control – from GMP DeltaV to next generation microcontrollers
- Single-Use Sensors – pH, pO2, pressure
- Moving downstream
Join an informal topical discussion hosted over a networking lunch. Discussions include:
Contamination Control
Protein expression in CHO cells: Comparison of GPEx® to a Traditional Cell Line Engineering Technology
Know your TRUE Cell Culture Conditions Accurately – Glucose, Glutamine, Lactate and others!
Single-use facilities - benefits and challenges
Addressing Cost of Quality and Compliance in the New Supply Chain Reality
The role of rapid automated microbial detection in 21st century Microbiology practices
Supply Chain Risk Monitoring
Science vs Art: Process Validation by Quality by Design" Quality by design mitigates the risks early in the development rather than late in the lifecycle.
- CIMmultusTM - Advanced Composite columns for purification of biologics - stainless steel performance for a price of disposable devices.
- New Protein A particle based chromatographic media to improve process economics of an antibody purification.
- Disposable CIM monolithic columns to improve process economics of antibodies and other biomolecules polishing steps.
Breakthrough technologies poised to revolutionize the industry
- Analyzing the current state of technology: room for improvement?
- Predictions for the next 5-10 years: what is on the horizon ?
- +20 years and blue sky thinking: what will be the future of bio-manufacturing?
Bernie Huyghe, Ph.D., RAC
Sr. Director, External Supply. Pharmaceutical Sciences, Biotherapeutics & Vaccines Outsourcing, Worldwide Research & Development
Pfizer USA
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