The leader in quality education and networking through//conferences, courses and custom training
Connect with IBC Life Sciences:
Registration
Download Brochure
Add to Outlook Calendar
Find Another IBC Event
Technology Transfer for Biopharmaceuticals
CSS
Alternate Language Options:
Maximizing Facility Throughput, Accelerating Timelines and Ensuring Partnership Success in Technology Transfer
February 27 - 28, 2012 · Hilton San Diego Bayfront Hotel · San Diego, CA
Agenda
Monday | Tuesday
8:15
Chairperson's Opening Remarks
Jon Conary, Ph.D., Senior Director, Manufacturing, Human Genome Sciences, Inc.
Jon Conary, Ph.D., Senior Director, Manufacturing, Human Genome Sciences, Inc.
Managing Risks in Technology Transfer
Featured Presentation
8:30
Avoiding Pitfalls During Tech Transfer - Mitigate Risks, Drive Efficiencies and Accelerate TimelinesDuring a product lifecycle process transfers are important to satisfy upcoming market demands, mitigate supply chain risks, etc. Usually most transfers require facility and process adaptations ('facility fit'). In order to mitigate risks for product quality, yields and timelines several measure need to be in place - examples and case studies will be presented.
Michael Pohlscheidt, Ph.D., EMBA, Associate Director, MSAT, Genentech
9:00
Using Quality Risk Management to Enable Flexible Multiproduct Biotech Manufacturing Facilities
Michael Parks, Manager, Site Technical Services, Pfizer Global Manufacturing
Michael Parks, Manager, Site Technical Services, Pfizer Global Manufacturing
9:30
Strategies to Derisk Downstream Technology Transfer and Manufacturing at CMO Site - Case Studies on Managing Instrument Change and Process Scale-Up
Downstream process transfer and manufacturing at CMO is challenging with various unknown factors such as instrument change, process scale-up etc.. Strategies to derisk these activities will be discussed through several detailed case studies focusing on managing instrument change and process scale-up.
Yun Bai, Ph.D., Associate Director, Process Sciences, Ambrx Inc.
Downstream process transfer and manufacturing at CMO is challenging with various unknown factors such as instrument change, process scale-up etc.. Strategies to derisk these activities will be discussed through several detailed case studies focusing on managing instrument change and process scale-up.
Yun Bai, Ph.D., Associate Director, Process Sciences, Ambrx Inc.
10:00
Networking Refreshment Break and Opening of Exhibit & Poster Hall
Facility Flexibility and Readiness in Technology Transfer
10:45
Facility Design and Technology Transfer Strategy for Flexible Multiproduct Large-Scale Biologics Manufacturing
Lonza's approach to utilize a flexible facility and a systematic technology transfer methodology to ensure successful manufacturing campaigns to meet customer's product requirements and project timelines will be discussed.
Manoj Menon, Ph.D., Associate Director, Manufacturing Science and Technology, Lonza Biologics
Lonza's approach to utilize a flexible facility and a systematic technology transfer methodology to ensure successful manufacturing campaigns to meet customer's product requirements and project timelines will be discussed.
Manoj Menon, Ph.D., Associate Director, Manufacturing Science and Technology, Lonza Biologics
11:30
How Flexible a Stainless Steel Facility Can Go - Manufacturing Solutions for Commercial and Clinical Supply
We currently observe a huge variety of process formats in development and clinical phases, e.g. high and low titer processes, different scales (clinical supply vs. commercial supply). The challenge for a CMO here is to ideally fit these different processes in its facility, thereby operating efficiently as a multi-product facility and serve the customers' needs. This presentation will focus on Boehringer Ingelheim's Biberach Site manufacturing capabilities and strategies in a changing CMO business environment. Higher titers and less demand for smaller patient populations forced to develop new strategies of utilizing the existing manufacturing facility to meet customers demand in the CMO business. We would like to provide some of our manufacturing solutions for these challenges, showing how smart and flexible process transfer concepts may look like in order to provide a fast launch and reliable market supply
Lars Dreesmann, Ph.D., Head of Upstream Manufacturing, Biopharmaceuticals, Boehringer-Ingelheim Pharma GmbH
We currently observe a huge variety of process formats in development and clinical phases, e.g. high and low titer processes, different scales (clinical supply vs. commercial supply). The challenge for a CMO here is to ideally fit these different processes in its facility, thereby operating efficiently as a multi-product facility and serve the customers' needs. This presentation will focus on Boehringer Ingelheim's Biberach Site manufacturing capabilities and strategies in a changing CMO business environment. Higher titers and less demand for smaller patient populations forced to develop new strategies of utilizing the existing manufacturing facility to meet customers demand in the CMO business. We would like to provide some of our manufacturing solutions for these challenges, showing how smart and flexible process transfer concepts may look like in order to provide a fast launch and reliable market supply
Lars Dreesmann, Ph.D., Head of Upstream Manufacturing, Biopharmaceuticals, Boehringer-Ingelheim Pharma GmbH
12:15
Networking Luncheon in Exhibit & Poster Hall
Case Studies on Overcoming Challenges in Technology Transfer
2:00
Biomanufacturing Industrialization and Technology Transfer of Bioconjugation Processes
This presentation will review Biomanufacturing Industrialization (BMI) activities on emerging bioconjugation modalities to optimize alignment of technologies and facility asset capabilities comprised of both disposable technologies and stainless steel, and coordinated and holistic efforts to develop predictive scaling models for process and systems to leverage facility capabilities. Activities to develop platforms for efficient process scaling and technology transfer will be introduced as well as some of the technical challenges encountered during bioconjugate process technology transfer and the application of BMI tools to address them.
Dan Stafford, Ph.D., Senior Principal Scientist, Pfizer, Inc.
This presentation will review Biomanufacturing Industrialization (BMI) activities on emerging bioconjugation modalities to optimize alignment of technologies and facility asset capabilities comprised of both disposable technologies and stainless steel, and coordinated and holistic efforts to develop predictive scaling models for process and systems to leverage facility capabilities. Activities to develop platforms for efficient process scaling and technology transfer will be introduced as well as some of the technical challenges encountered during bioconjugate process technology transfer and the application of BMI tools to address them.
Dan Stafford, Ph.D., Senior Principal Scientist, Pfizer, Inc.
2:30
Challenges and Considerations for Technology Transfer of a "Non-Platform" Purification Process
Many companies have realized benefits of shortened process development time and efficient technology transfer for monoclonal antibodies by applying a platform process approach. However, when a platform process is not feasible due to specific product quality considerations, the impact to timelines, facility fit, and cost of goods must be carefully considered. A case study will be examined in which a non-platform mAb purification process was transferred into a multi-product clinical manufacturing facility.
Jaclyn Shaffer, Associate Scientist, MedImmune, Inc.
Many companies have realized benefits of shortened process development time and efficient technology transfer for monoclonal antibodies by applying a platform process approach. However, when a platform process is not feasible due to specific product quality considerations, the impact to timelines, facility fit, and cost of goods must be carefully considered. A case study will be examined in which a non-platform mAb purification process was transferred into a multi-product clinical manufacturing facility.
Jaclyn Shaffer, Associate Scientist, MedImmune, Inc.
3:00
Maximizing Facility Throughput for Technology Transfer of Mixed and Variable Titer Products, and Non-Standard Purification Processes
Rick Johnston, Ph.D., Executive Director, CELDi Center, University of California at Berkeley
Rick Johnston, Ph.D., Executive Director, CELDi Center, University of California at Berkeley
3:30
Networking Refreshment Break in Exhibit & Poster Hall
Keynote Session
4:00
Chairperson's Introductory Remarks
David Reifsnyder, Ph.D., Head, Process Validation, Genentech, Inc.
David Reifsnyder, Ph.D., Head, Process Validation, Genentech, Inc.
4:10
Biologics Product & Process Lifecycle Management: Genentech / Roche ExperienceIn the past three decades, Genentech has successfully launched 16 therapeutic biologics. The challenges of managing our legacy products are complicated by a diverse and global manufacturing network. In addition, Genentech, as a member of the Roche group, had to manage our legacy products while supporting a large number of new biological products still in clinical development. This presentation will focus on the Genentech/Roche lifecycle management strategy that supports our entire portfolio of biological products.
David Chang, Ph.D., Senior Director, Global Biologics Manufacturing Science & Technology, Genentech, Inc., a member of the Roche group
4:50
Facility Fit Analysis - The First Step in a Long JourneyMedImmune recently licensed a new state of the art 360,000 square foot large scale mammalian cell culture manufacturing facility. The facility, designed for the manufacture of MedImmune's pipeline products, has a high degree of flexibility to assure the manufacturability of a broad range of product titers. The challenge faced by MedImmune is to identify and establish an efficient technology transfer process while maintaining a flexible approach to product processing requirements.
Greg Liposky, Vice President & General Manager, Site Operations, MedImmune
5:30
Cocktail Reception in Exhibit & Poster Hall
Monday | Tuesday
8:00
Chairperson's Opening Remarks
Jean Bender, Ph.D., Director, BioProcess Engineering, MedImmune, Inc.
Jean Bender, Ph.D., Director, BioProcess Engineering, MedImmune, Inc.
Ensuring Partnership Success During Technology Transfer & Outsourcing
8:15
Technology Transfer in a Partnership: How Johnson & Johnson and Biogen Idec Designed the Foundation, Governance and Execution for Enduring Success
Gene Schaefer, Sc.D., Senior Director, Large Scale API Development, Janssen Pharmaceutical Companies of Johnson & Johnson and
Marcelo Anderson, MBA, Associate Director Manufacturing Sciences, Biogen Idec
Gene Schaefer, Sc.D., Senior Director, Large Scale API Development, Janssen Pharmaceutical Companies of Johnson & Johnson and
Marcelo Anderson, MBA, Associate Director Manufacturing Sciences, Biogen Idec
8:45
Challenges and Strategies for Establishing a Vendor Network for Antibody Drug Conjugates
Antibody Drug Conjugates (ADCs) are showing clinical promise and thus undergoing rapid growth as a major oncology therapeutic class. Manufacturing of ADCs require specialized facilities and a staff experienced in biology, process chemistry and handling of cytotoxic materials. The focus of this presentation will be the challenges that exist in outsourcing ADC manufacture.
Vincent Turula, Ph.D., Director, Biotherapeutics & Vaccines Outsourcing, Pfizer, Inc.
Antibody Drug Conjugates (ADCs) are showing clinical promise and thus undergoing rapid growth as a major oncology therapeutic class. Manufacturing of ADCs require specialized facilities and a staff experienced in biology, process chemistry and handling of cytotoxic materials. The focus of this presentation will be the challenges that exist in outsourcing ADC manufacture.
Vincent Turula, Ph.D., Director, Biotherapeutics & Vaccines Outsourcing, Pfizer, Inc.
Panel Discussion
9:15
Protecting Intellectual Property While Preserving Collaboration during Tech Transfer
Moderator: Jean Bender, Ph.D., Director, BioProcess Engineering, MedImmune, Inc.
Panelists:
Marcel Anderson, MBA, Associate Director Manufacturing Sciences, Biogen Idec
Vincent Turula, Ph.D., Director, Biotherapeutics & Vaccines Outsourcing, Pfizer, Inc.
Rick Johnston, Ph.D., Executive Director, CELDi Center, University of California at Berkeley
- Have you struggled with how to protect your company's intellectual property at the same time you are asked to collaborate on process issues as part of technology transfer to an external manufacturing site (CMO)?
- How best to share plant data for multiple product facilities? What happens if there is an issue for one client's process that results in changes to another client's process?
- How are trade secrets and company best practices differentiated?
- If you've figured out a good solution to a processing issue, how do you know if this is confidential information or are you being a good partner by sharing?
Moderator: Jean Bender, Ph.D., Director, BioProcess Engineering, MedImmune, Inc.
Panelists:
Marcel Anderson, MBA, Associate Director Manufacturing Sciences, Biogen Idec
Vincent Turula, Ph.D., Director, Biotherapeutics & Vaccines Outsourcing, Pfizer, Inc.
Rick Johnston, Ph.D., Executive Director, CELDi Center, University of California at Berkeley
10:00
Networking Refreshment Break in Exhibit & Poster Hall
Strategies for External Manufacturing and Measuring Its KPI
10:45
Strategies for Pre-Commercial Externalization
In this era of mergers and acquisitions, collaborative manufacturing partnerships, and increased outsourcing deals, the biopharmaceutical industry faces the challenge of adopting the best externalization strategies that are financially sound, and that ensure adequate oversight without hindering a CMO's operational efficiency. This presentation will provide an insight into Big Pharma's pre-commercial outsourcing strategies that will deliver "win-win" situations for both Sponsor and CMO.
Firelli Alonso-Caplen, Ph.D., Senior Director, Biotherapeutics & Vaccines Outsourcing, Pfizer, Inc.
In this era of mergers and acquisitions, collaborative manufacturing partnerships, and increased outsourcing deals, the biopharmaceutical industry faces the challenge of adopting the best externalization strategies that are financially sound, and that ensure adequate oversight without hindering a CMO's operational efficiency. This presentation will provide an insight into Big Pharma's pre-commercial outsourcing strategies that will deliver "win-win" situations for both Sponsor and CMO.
Firelli Alonso-Caplen, Ph.D., Senior Director, Biotherapeutics & Vaccines Outsourcing, Pfizer, Inc.
11:15
Applying Operational Excellence and Performance Measurement to Contract Manufacturing
Lei Shi, MBA, MS, Director, Contract Manufacturing, Amgen Inc.
Lei Shi, MBA, MS, Director, Contract Manufacturing, Amgen Inc.
Technology Workshop
11:45
Building biopharmaceutical manufacturing capacity was a lengthy, expensive and relatively inflexible process. This was a major barrier to entry into the biopharmacueitcal marketplace for smaller companies. Gallus Biopharmaceuticals recently completed an expansion using new technologies that helped minimize cost and time while providing future flexbility. Gallus offers contract manufacturing services and personalized manufacturing areas, reducing the financial burden of entry.
David J. Kenyon, Ph.D., Senior Director, Development Business Unit, Gallus Biopharmaceuticals
12:15
Networking Luncheon in Exhibit & Poster Hall
1:50
Chairperson's Remarks
Rick Johnston, Ph.D., Executive Director, CELDi Center, University of California at Berkeley
Rick Johnston, Ph.D., Executive Director, CELDi Center, University of California at Berkeley
Supply Chain Risk Management
2:00
Supply Chain Risk: Collaborative Research Results and Lessons from Other Industries
As the biopharmaceutical industry matures, the focus on supply chain risk awareness and mitigation is increasing. To address these and related issues, the National Science Foundation sponsors a collaborative industry/academia research initiative housed at UC Berkeley. In this presentation, we explore results of the research initiative's ongoing survey of biopharmaceutical supply chain risks, present a summary of lessons learned from other industries, and introduce novel analytical tools and approaches used to analyze and quantify the effectiveness of supply chain risk mitigation strategies.
Phil Kaminsky, Ph.D., Professor and Chair, Industrial Engineering and Operations Research; Director, The Initiative for Research in Biopharmaceutical Operations, University of California, Berkeley
As the biopharmaceutical industry matures, the focus on supply chain risk awareness and mitigation is increasing. To address these and related issues, the National Science Foundation sponsors a collaborative industry/academia research initiative housed at UC Berkeley. In this presentation, we explore results of the research initiative's ongoing survey of biopharmaceutical supply chain risks, present a summary of lessons learned from other industries, and introduce novel analytical tools and approaches used to analyze and quantify the effectiveness of supply chain risk mitigation strategies.
Phil Kaminsky, Ph.D., Professor and Chair, Industrial Engineering and Operations Research; Director, The Initiative for Research in Biopharmaceutical Operations, University of California, Berkeley
Panel Discussion
2:45
Raw Materials & Supply Chain Management and Its Impact on Technology Transfer and Outsourcing
Moderator: Ran Zheng, Ph.D., Executive Director, Plant Manager, Amgen Inc.
Panelists:
Fauad Hasan, Project Manager, Biopharmaceutical Process Sciences, Allergan, Inc.
Gene Schaefer, Sc.D., Senior Director, Large Scale API Development, Janssen Pharmaceutical Companies of Johnson & Johnson
Susan Lenk, Ph.D., Principal Scientist, PDMS API-Large Molecule, Janssen Pharmaceutical Companies of Johnson & Johnson
Greg Page, Associate Director, Global Supplier Quality, Janssen Supply Group
Moderator: Ran Zheng, Ph.D., Executive Director, Plant Manager, Amgen Inc.
Panelists:
Fauad Hasan, Project Manager, Biopharmaceutical Process Sciences, Allergan, Inc.
Gene Schaefer, Sc.D., Senior Director, Large Scale API Development, Janssen Pharmaceutical Companies of Johnson & Johnson
Susan Lenk, Ph.D., Principal Scientist, PDMS API-Large Molecule, Janssen Pharmaceutical Companies of Johnson & Johnson
Greg Page, Associate Director, Global Supplier Quality, Janssen Supply Group
3:30
Networking Refreshment Break and Last Chance for Exhibit & Poster Viewing
Evaluation and Quality Management of Supplier-Derived Raw Materials
4:00
Raw Material Evaluation and Qualification: Moving from Development into Commercial
Susan Lenk, Ph.D., Principal Scientist, PDMS API-Large Molecule, Janssen Pharmaceutical Companies of Johnson & Johnson
Susan Lenk, Ph.D., Principal Scientist, PDMS API-Large Molecule, Janssen Pharmaceutical Companies of Johnson & Johnson
4:30
Raw Material Qualification Process and Supplier Management: Phase I Through Commercial
Greg Page, Associate Director, Global Supplier Quality, Janssen Supply Group
Greg Page, Associate Director, Global Supplier Quality, Janssen Supply Group
5:00
Quality Management Best Practices in the Raw Material Supply Chain
It is critical to understand raw material suppliers' manufacturing capabilities and to monitor supplier performance, beginning in the early phases of product development. Alignment of material specifications and verification of assay results are critical to ensure an uninterrupted supply of raw materials throughout the lifetime of product. Key components of a robust supplier quality management program that enable this include supplier auditing, monitoring of changes, Quality Agreements and scorecard creation. Drug manufacturers should build collaborative relationships with their suppliers to allow for information sharing and timely resolution if issues do arise. Case studies and best practices in the supplier / drug manufacturer relationship will be explored during this discussion.
Kimberly Carnes, Manager, Quality Assurance Compliance, Human Genome Sciences, Inc.
It is critical to understand raw material suppliers' manufacturing capabilities and to monitor supplier performance, beginning in the early phases of product development. Alignment of material specifications and verification of assay results are critical to ensure an uninterrupted supply of raw materials throughout the lifetime of product. Key components of a robust supplier quality management program that enable this include supplier auditing, monitoring of changes, Quality Agreements and scorecard creation. Drug manufacturers should build collaborative relationships with their suppliers to allow for information sharing and timely resolution if issues do arise. Case studies and best practices in the supplier / drug manufacturer relationship will be explored during this discussion.
Kimberly Carnes, Manager, Quality Assurance Compliance, Human Genome Sciences, Inc.
5:30
Close of Conference
Copyright IBC Life Sciences, a part of Informa Life Sciences Group. Phone: 800.390.4078 Email: reg@ibcusa.com