Outsourcing Manufacturing of Biopharmaceuticals
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Event Information
Document Title
Agenda
Day One: Monday | Day Two: Tuesday
8:00
Chairperson's Opening Remarks
Shelley Suggett, Product Manager, Global Supply Chain, Genentech, Inc.
Shelley Suggett, Product Manager, Global Supply Chain, Genentech, Inc.
Keynote Presentations
8:15
Lessons Learned and Where are We Going? - A CMOs PerspectiveThe talk will focus on the lessons learned for developing a successful client-to-CMO relationship. The process from first contact, initial discussions and contract negotiations through quality agreement, process fit, technology transfer, and expectation management will be discussed. Key points will include
- The details of the contract versus the spirit of the contract
- Expectations versus contract language
- How much should be delegated to the CMO and how involved should the client be?
- A reality check on how developed the process is and the facility fit
John McGrath, Business Unit Head, Lonza Biologics
9:00
The Critical Elements of a Successful Regulatory Filing for Outsourcing Biopharmaceutical ManufacturingThis presentation will provide an overview of relevant submission content and successful regulatory strategies that enable timely FDA and EMEA approvals for drug substance and drug product transfers to new manufacturing sites. Specific emphasis will be placed on how to identify and manage:
- Health Authority expectations and concerns
- Management team expectations
- Submission and inspection risk
Terry Milby, M.S., Director, Regulatory CMC, Genentech, Inc.
9:45
Networking Refreshment Break in Exhibit/Poster Hall
The Critical Roles of Due Diligence and Risk Management
Chairperson: Shelley Suggett, Product Manager, Global Supply Chain, Genentech, Inc.
10:30
Case
Study
Integrating Risk Management into Contract Manufacturing and the Larger OrganizationStudy
Risk management is a critical component of any outsourcing program. This presentation will describe an approach for designing and implementing a risk management process, highlight critical success factors for getting engagement from the CMO and the outsourcing company, and identify challenges associated with integrating the process into the outsourcing organization.
Roger Symczak, MBA, Product Supply Chain Leader, Genentech, Inc.
11:00
Case
Study
Case Study: Analytical Due Diligence to Enable Multi-Project Platform Analytics SupportStudy
A successful due diligence is the key to establishing contract partners. The case study details the due diligence executed towards identifying suitable analytical contract organizations. The discussion includes identification of business and technical controls, review of deselection factors at Lab A requiring the transition to Lab B, review of the technology transfer strategy to enable Lab A & B and data comparability between Labs. The case concludes with a lesson learned analysis and risk mitigation suggestions.
Paul R. Mehelic, MBA, M.S., Principal Scientist and Group Leader, Global Biologics, Pfizer Inc.
11:30
Case
Study
Process Transfer and Management in the View of Clients and CMO's, Including Technology Transfer to a CMO, Critical Points, How to Manage Discrepancies, Case Studies and ExamplesStudy
Zooming into the relationship between a CMO and customer based on DSM experiences in custom manufacturing services. Examples are given how issues between parties can arise during the different project phases: information exchange, cell-line development, process development, scale-up and cGMP manufacturing, with different dynamics in every phase. Besides the more "technical" factors also the human factors between parties are addressed.
Rolf Douwenga, M.S., Vice President, Global Research and Development, DSM Biologics, The Netherlands
12:00
Technology Workshop
IBC's technology workshops offer technology providers an opportunity to discuss practical applications of their technology during the conference. For more information about this sponsorship, please contact Kristen Schott, Tel: 508-614-1239, Email: kschott@ibcusa.com
IBC's technology workshops offer technology providers an opportunity to discuss practical applications of their technology during the conference. For more information about this sponsorship, please contact Kristen Schott, Tel: 508-614-1239, Email: kschott@ibcusa.com
12:30
Luncheon in Exhibit/Poster Hall
1:45
Chairperson's Remarks
Paul R. Mehelic, MBA, M.S., Principal Scientist & Group Leader, Analytical Research and Development, Global Biologics, Pfizer Inc.
Paul R. Mehelic, MBA, M.S., Principal Scientist & Group Leader, Analytical Research and Development, Global Biologics, Pfizer Inc.
Contracts and Quality Agreements
2:00
Aligning Expectations between Clients and CMOs Early in the Process
This presentation provides insight on the importance of early alignment between clients and CMOs to best position client sourcing strategy with external capabilities. The early formation of effective cross-functional teams is critical to manage cost and resources required to "onboard" new CMOs. The outsourcing coordination role can be a key to the formation of the team, and successful continuation of the project.
Gerry Boushelle, M.S., Outsourcing Coordinator, Global Biologics Research & Development, Pfizer Inc.
This presentation provides insight on the importance of early alignment between clients and CMOs to best position client sourcing strategy with external capabilities. The early formation of effective cross-functional teams is critical to manage cost and resources required to "onboard" new CMOs. The outsourcing coordination role can be a key to the formation of the team, and successful continuation of the project.
Gerry Boushelle, M.S., Outsourcing Coordinator, Global Biologics Research & Development, Pfizer Inc.
2:30
Lessons Learned on the Critical Components that Belong in Contracts and Quality Agreements
Does your firm use contract manufacturers or contract laboratories? We've all experienced this before - the contract is signed, everyone celebrates, and now it's time to go to work. The only problem is that there are questions left unanswered by the business contract. A Quality Agreement is critical to clarify and document the responsibilities and expectations between the contract giver and contract acceptor regarding quality aspects of the outsourced activity. This is where a Quality Agreement goes into action. Understanding the underlying purpose of a Quality Agreement clarifies the functional and quality aspects of a business relationship. It will define, in significant detail, the responsibilities of quality, regulatory and production personnel within each company and improve communication. Learn the key elements and the international regulatory requirements for a quality agreement to avoid surprises and misunderstandings that could result in regulatory issues or work of unacceptable quality.
Barbara B. Zinck, President, Zinck Consulting LLC
Does your firm use contract manufacturers or contract laboratories? We've all experienced this before - the contract is signed, everyone celebrates, and now it's time to go to work. The only problem is that there are questions left unanswered by the business contract. A Quality Agreement is critical to clarify and document the responsibilities and expectations between the contract giver and contract acceptor regarding quality aspects of the outsourced activity. This is where a Quality Agreement goes into action. Understanding the underlying purpose of a Quality Agreement clarifies the functional and quality aspects of a business relationship. It will define, in significant detail, the responsibilities of quality, regulatory and production personnel within each company and improve communication. Learn the key elements and the international regulatory requirements for a quality agreement to avoid surprises and misunderstandings that could result in regulatory issues or work of unacceptable quality.
Barbara B. Zinck, President, Zinck Consulting LLC
Panel Discussion
3:00
Technical Aspects and Issues Surrounding Due Diligence
This panel discussion will be a follow up for further exploration of the technical issues an organization encounters with contract partners. Participants will focus on key challenges of performing due diligence and offer possible solutions to help minimize risk, establish and maximize the CMO partnership, including:
This panel discussion will be a follow up for further exploration of the technical issues an organization encounters with contract partners. Participants will focus on key challenges of performing due diligence and offer possible solutions to help minimize risk, establish and maximize the CMO partnership, including:
- Components of the due diligence process and key considerations.
- Key attributes towards selecting suitable outsourcing partners.
- Strategic evaluation and identification of sponsor activities suitable to outsource.
- Technical and financial considerations impacting the outsourcing decision process.
3:30
Networking Refreshment Break in Exhibit/Poster Hall
Chairperson: David Reifsnyder, Ph.D., Principal Scientist, Biopharma Development, Genentech, Inc.
Featured Presentations
4:00
Case
Study
Upstream Process Development Using a QbD Approach - Results from the CMC Biotech Working Group Case StudyStudy
The QbD approach for upstream development of a monoclonal antibody as described in the recent industry consortium case study (CMC BWG) will be presented. The case study provides examples of the risk assessment strategy and tools linking process to attributes, the use of prior platform knowledge and experimental design for mammalian cell culture development, the concept of an engineering design space for the bioreactors, and potential implications for validation and lifecycle.
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Bioproduct R&D, Eli Lilly and Company
4:30
Case
Study
Downstream Process Development Using a QbD Approach - Results from the CMC Biotech Working Group Case StudyStudy
The QbD approach for the downstream development of a monoclonal antibody as described in the recent industry consortium case study (CMC BWG) will be presented. This presentation will focus on risk assessments, DOEs and process characterization studies that provide a science-based approach to process understanding, definition of design space and establishment of the control strategy.
Amit Banerjee, Ph.D., Research Fellow, Global Biologics, Pfizer Inc.
5:00
Networking Cocktail Reception in Exhibit/Poster Hall
Day One: Monday | Day Two: Tuesday
8:00
Chairperson's Opening Remarks
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Bioproduct R&D, Eli Lilly and Company
Victor A. Vinci, Ph.D., Director, Bioprocess Operations, Bioproduct R&D, Eli Lilly and Company
Keynote Presentations
8:15
Global Regulatory Strategies for Validation and Transfer of Biotech Processes and ProductsAs little as 15 years ago the opportunity to perform contract manufacturing for biologic products simply did not exist. since that time, the industry has seen explosive growth in biologic CMO's with many of the major biotechnology producers successfully utilizing this approach. Nevertheless, the key to this success is a flawless transfer of both the process technology and Analytical technology. Some examples of successful and unsuccessful product transfers will be discussed as well as key validation requirements.
Robert L. Garnick, Ph.D., President & CEO, Lone Mountain Biotechnology and Medical Devices, Inc.
8:45
"It's Not About the Molecule!": Capability, Competency, and Suitability in Biopharmaceutical ManufacturingJeffrey Baker, Ph.D., Senior Director, Manufacturing Sciences, MedImmune
Featured Presentation
9:15
Case
Study
Humira History - The Impact of Global Technology Transfers and Validation - Challenges and Lessons LearnedStudy
The first fully human monoclonal antibody, Humira, entered clinical evaluation in 1996 and launched in 2002. More than $5 Billion sales in over 70 countries are anticipated this year. Humira's explosive growth parallels the maturation of the biologics industry in this timeframe. To cope with this growth, as well as globalization, technological improvements and changing regulatory perspectives, the Humira supply chain had to adjust. The talk will illustrate some lessons learned and discuss how we are preparing for the future.
George Avgerinos, Ph.D., Senior Director, Humira Technical Operations, Abbott Laboratories
9:45
Networking Refreshment Break in Exhibit/Poster Hall
Overcoming the Challenges of Outsourcing Antibody Drug Conjugates
Chairperson: Rolf Douwenga, MSc, Vice President, Global Research and Development, DSM Biologics, The Netherlands
10:15
Outsourcing Complexities - A Small Company Approach
CR011 is an antibody-drug conjugate (ADC) armed with a cytotoxic payload. The manufacture of CR011 presents unique challenges since a number of intermediates are required to make the drug substance. Since CuraGen does not have its own manufacturing facilities, the manufacture of these intermediates needs to be outsourced. Outsourcing for these intermediates requires different specialized CMOs. This requires a high degree of planning and coordination. The selection criteria for choosing the right CMO is very critical. Some of the challenges and pitfalls associated with our approach will be discussed.
Cyrus Karkaria, Ph.D., Vice President, Operations, CuraGen Corporation
CR011 is an antibody-drug conjugate (ADC) armed with a cytotoxic payload. The manufacture of CR011 presents unique challenges since a number of intermediates are required to make the drug substance. Since CuraGen does not have its own manufacturing facilities, the manufacture of these intermediates needs to be outsourced. Outsourcing for these intermediates requires different specialized CMOs. This requires a high degree of planning and coordination. The selection criteria for choosing the right CMO is very critical. Some of the challenges and pitfalls associated with our approach will be discussed.
Cyrus Karkaria, Ph.D., Vice President, Operations, CuraGen Corporation
10:45
Case
Study
The Lessons Learned and Unique Challenges Encountered while Moving from Internal Research to Outsourced Clinical Manufacturing for an Antibody Drug ConjugateStudy
The outsourcing of manufacturing for a potent molecule small molecule and subsequent conjugation to an antibody has proven to be more challenging than other outsourcing projects. In this talk I will share our experiences as we utilized outsourced manufacturing organizations to prepare the toxicology and clinical lots of antibody drug conjugate.
Paul W. Guptill, M.S., Senior Director, Manufacturing Services, Medarex
11:15
ADC Supply Chain Analysis - Strategies for Success from CMO Selection to Market Launch Planning
An Antibody Drug Conjugate (ADC) is a new medical therapy that combines a biotech product with a toxin, creating a molecule with "breakthrough" potential for unmet medical needs. This discussion will explore aspects of CMO selection and regulatory considerations that impact the supply chain and launch of this unique class of drug.
Shelley Suggett, Product Manager, Global Supply Chain, Genentech, Inc.
An Antibody Drug Conjugate (ADC) is a new medical therapy that combines a biotech product with a toxin, creating a molecule with "breakthrough" potential for unmet medical needs. This discussion will explore aspects of CMO selection and regulatory considerations that impact the supply chain and launch of this unique class of drug.
Shelley Suggett, Product Manager, Global Supply Chain, Genentech, Inc.
11:45
Technology Workshop
IBC's technology workshops offer technology providers an opportunity to discuss practical applications of their technology during the conference. For more information about this sponsorship, please contact Kristen Schott, Tel: 508-614-1239, Email: kschott@ibcusa.com
IBC's technology workshops offer technology providers an opportunity to discuss practical applications of their technology during the conference. For more information about this sponsorship, please contact Kristen Schott, Tel: 508-614-1239, Email: kschott@ibcusa.com
12:15
Luncheon in Exhibit/Poster Hall
1:15
Chairperson's Remarks
Jean Bender, Ph.D., Principal Engineer, Genentech, Inc.
Jean Bender, Ph.D., Principal Engineer, Genentech, Inc.
Ensuring Success and Quality of External Transfers - Sender and Recipient Perspectives
1:30
Case
Study
Facility Start-up and Process Technology Transferinto the Biologics Manufacturing Facility in Singapore - A Joint Genentech-Lonza PresentationStudy
The recent successful start-up and process transfer into the Singapore large-scale biologics manufacturing facility represents a unique example of a CMO-customer collaboration. The facility was built and commissioned by Lonza, with input and oversight from Genentech. The facility was acquired by Genentech just prior to the start of process validation runs. This presentation will include an overview of the facility design and start-up strategy of a greenfield facility, strategies and tools employed to facilitate the transfer of a marketed MAb process into the Facility, and review of lessons learned during this process.
Eric T. Ford, Senior Manufacturing Technical Specialist, Genentech, Inc.
Manoj K. Menon, Ph.D., Senior Manager, Manufacturing Science and Technology, Lonza Biologics, Singapore
2:00
Model for Quality Oversight of Third Party Manufacturers (TPMs)
This presentation will review a model for oversight of two separate TPMs (one domestic, one international) who manufacture the biologics drug substance used for ORENCIA®. The model includes quality oversight during technology transfer and process validation, establishment of Bristol-Myers Squibb quality personnel at the TPMs for oversight of manufacturing, deviations, change controls and batch release, and post-approval monitoring and comparison of process performance.
Brett Budis, Ph.D., Associate Director, Biologics Quality, Bristol-Myers Squibb
This presentation will review a model for oversight of two separate TPMs (one domestic, one international) who manufacture the biologics drug substance used for ORENCIA®. The model includes quality oversight during technology transfer and process validation, establishment of Bristol-Myers Squibb quality personnel at the TPMs for oversight of manufacturing, deviations, change controls and batch release, and post-approval monitoring and comparison of process performance.
Brett Budis, Ph.D., Associate Director, Biologics Quality, Bristol-Myers Squibb
2:30
Case
Study
Challenges Encountered during the External Transfer of Potency MethodsStudy
The transfer of potency methods to production sites, partners, or Contract Manufacturing Organizations can be particularly challenging due to the reliance of these methods on analyst technique, critical equipment and/or reagents and the use of cell cultures. This presentation will discuss the challenges and lessons learned from the transfer process of several molecules.
Carl Co, Ph.D., Associate Scientist, Biological Technologies, Genentech, Inc.
3:00
Networking Break in Exhibit/Poster Hall
Transfer of Analytical Methods
3:30
Case
Study
Successful Transfers of Analytical Methods - Case Studies on Assay TransfersStudy
The successful transfer of analytical methods for in-process, release and stability testing is a generally structured process and is well defined. The process includes the development and execution of a transfer plan, training plans, transfer protocols, and finally transfer reports. This talk will focus on the approach to method transfer to and from HGS. Particular attention will be given to the tactics for navigating unexpected detours and managing the traffic of the transfer.
Michael S. Lemar, Senior Scientist I, Analytical Sciences, Human Genome Sciences, Inc.
4:00
Case
Study
Transfer of Analytical Methods - Experience and Lessons Learned from 20 Years as a Contract ManufacturerStudy
Reliable analytical method transfer is critical to the success of a contract manufacturing organization (CMO). In an environment where methods from multiple customers laboratories are employed, the transfer process must be effective. It is imperative that both transferring and receiving laboratories understand the process and their responsibilities. Experience of method transfers, including lessons learnt, has determined our current approach.
Adam Mott, Director of Quality Control, Lonza Biologics
4:30
Case
Study
Approach and Challenges for Analytical Methods Transfer to Multiple Testing SitesStudy
Transfer of analytical methods is required at various points during the development of pharmaceuticals and biopharmaceuticals. The impetus for analytical method transfers include: a change in internal manufacturing sites, load sharing across the company, a change in testing methods, a need for increased analytical capacity or transfer to an external manufacturer. Independent of the reasons for transfer, it is important to perform analytical methods transfers using a solid scientific basis to ensure results are consistent with historical values and across sites. For this presentation, a mAb project will be used as a case study to illustrate method transfer challenges and practical approaches to mitigate them as the project progressed from early stage development through commercial launch. Strategies for the transfer of methods to other company sites, CMOs and CROs, for in-process, release and stability testing will be presented.
Roberto Rodriguez, Principal Scientist, Analytical Research and Development, Pfizer Inc.
5:00
Close of Conference
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