IBC Life Sciences
The leading provider of scientific, technological and business information
Main menu
My IBC
Process & Product Validation
CSS
Event Information
Document Title
Agenda
Day One: Monday | Day Two: Tuesday
8:00
Chairperson's Opening Remarks
Siddharth J. Advant, Ph.D., Senior Director, CMC Project Management, ImClone Systems Corp., a wholly-owned subsidiary of Eli Lilly & Co.
Siddharth J. Advant, Ph.D., Senior Director, CMC Project Management, ImClone Systems Corp., a wholly-owned subsidiary of Eli Lilly & Co.
Process Monitoring - Prospective and Retrospective Approaches
8:15
Case
Study
Integration and Practical Approaches to Process Monitoring as Part of Process Validation LifecycleStudy
Recent ICH and FDA guidance documents have highlighted process monitoring as an integral part of the process validation lifecycle. Amongst other benefits, process monitoring is useful to ensure process and product consistency, to enhance process understanding, and to manage risk. This case study will focus on strategies for integrating process monitoring of commercial manufacturing as part of the process validation lifecycle and its application in QbD paradigm. Practical approaches and specific examples to process monitoring will also be discussed.
Meliana Ratna, Process Engineer, Manufacturing Sciences, Genentech, Inc.
8:45
Process Monitoring During and Post Commercialization of Biologics
Process Monitoring is one of the key components of commercialization process and it is interconnected with characterization, validation and in-process controls. The robustness of the manufacturing process is demonstrated through process characterization and the reproducibility of the process for delivering the product within specifications is proven through validation. Process specifications, determined based on characterization and validation data, are included in regulatory filings. Establishment of process monitoring program takes place in stages. In the initial stages, the manufacturing data, representative of current operations, is trended. There are challenges in this stage, especially when the manufacturing data is limited and the data for a given parameter is not normally distributed. In later stages, statistical control limits can be established after evaluating the distribution pattern of the data that contains a statistically meaningful number of manufacturing runs. Process monitoring program can embrace multivariate techniques based on multivariate analysis (MVA) to achieve real-time multivariate statistical process monitoring (RT-MSPM). Process monitoring is very well aligned with QbD Design Space and in-depth process understanding paradigm. Continuous process and product verification through process monitoring is part of QbD control strategy to ensure that the quality attributes are maintained within the acceptable ranges for identity, strength, quality, purity, safety, on a lot to lot basis and the implemented changes within the design space do not impact quality attributes critical to the safety and efficacy.
Neslihan DelaCruz, Principal Engineer, Process Development, Amgen Inc.
Process Monitoring is one of the key components of commercialization process and it is interconnected with characterization, validation and in-process controls. The robustness of the manufacturing process is demonstrated through process characterization and the reproducibility of the process for delivering the product within specifications is proven through validation. Process specifications, determined based on characterization and validation data, are included in regulatory filings. Establishment of process monitoring program takes place in stages. In the initial stages, the manufacturing data, representative of current operations, is trended. There are challenges in this stage, especially when the manufacturing data is limited and the data for a given parameter is not normally distributed. In later stages, statistical control limits can be established after evaluating the distribution pattern of the data that contains a statistically meaningful number of manufacturing runs. Process monitoring program can embrace multivariate techniques based on multivariate analysis (MVA) to achieve real-time multivariate statistical process monitoring (RT-MSPM). Process monitoring is very well aligned with QbD Design Space and in-depth process understanding paradigm. Continuous process and product verification through process monitoring is part of QbD control strategy to ensure that the quality attributes are maintained within the acceptable ranges for identity, strength, quality, purity, safety, on a lot to lot basis and the implemented changes within the design space do not impact quality attributes critical to the safety and efficacy.
Neslihan DelaCruz, Principal Engineer, Process Development, Amgen Inc.
9:15
Case
Study
Risk Based Parameter Selection and Evaluation to Meet FDA's Continued Process Verification RequirementsStudy
The new FDA Process Validation Guidance now clearly extends process validation to include ongoing monitoring or verification. By carefully selecting Continued Verification parameters firms can realize cost savings, achieve more rigorous process evaluation and comfortably enhance regulatory compliance. Examples will be given using both FMEA risk analysis and statistical process control charts to identify and justify Critical Process Parameters.
Peter K. Watler, Ph.D., Principal Consultant, Hyde Engineering + Consulting, Inc.
9:45
Networking Refreshment Break in Exhibit/Poster Hall
Advances/Challenges in Drug Product Validation
10:30
Case
Study
A Holistic Approach to Drug Product Process Characterization and Validation for a Monoclonal Antibody Using QbD ConceptsStudy
A holistic approach to drug product process validation is used at Genentech. QbD tools are imbedded in the program design. Scale independent and scale dependent studies are determined using risk ranking and filtering tools. Small scale models have been designed to appropriately test operation robustness and these will be described as well as tools to assess the need for PAT and process verification.
Fredric Lim, Ph.D., Principal Engineer, Late Stage Pharmaceutical & Processing Development, Genentech, Inc.
11:00
Case
Study
Predicting Validation Probability of Success - A Statistical ApproachStudy
A novel statistical approach to assess failure risk during process validation lots will be presented. the approach highlighted the need for an aligned approach across Drug Substance (DS), Drug Product (DP) and analytical functions in definition of final specifications, acceptable analytical variability, and process capability. A case study of how this approach was leveraged to ensure success during process validation will also be presented.
Rajiv Mahajan, Ph.D., Associate Director, Therapeutic Protein Technology, Merck & Co., Inc.
11:30
Biologics Drug Product Development Using a Quality by Design Approach - Results from the CMC Biotech Working Group Case Study
Abstract not available at press date.
Satish Singh, Ph.D., Research Fellow, Global Biologics R&D, Pfizer Inc
Abstract not available at press date.
Satish Singh, Ph.D., Research Fellow, Global Biologics R&D, Pfizer Inc
Technology Workshop
12:00
The impact of Mass Spectrometry analysis on decision making in the Development of Biotherapeutics will be detailed. Topics covered include:
- Sequence Analysis of Intact Proteins and Peptide Digests
- Detection of Protein Modifications
- Truncations
- Mutations
- Identification of Sites of Post Translational Modifications
- Phosphorylation
- Glycosylation
- Analysis of Glycans
- N- and O-Linked Sugars
12:30
Luncheon in Exhibit/Poster Hall
1:45
Chairperson's Remarks
David Reifsnyder, Ph.D., Principal Scientist, Biopharma Development, Genentech, Inc.
David Reifsnyder, Ph.D., Principal Scientist, Biopharma Development, Genentech, Inc.
2:00
Development and Use of Reduced-Scale Chromatography Models as a Tool for Biopharmaceutical Process Validation
Scaled-down laboratory models prove useful for generating prospective validation data in the development of biopharmaceuticals. These models are designed to mimic the manufacturing-scale process step and must be qualified before use. This presentation will discuss qualification of a scaled-down chromatography model and its subsequent use to generate process characterization/validation data including Design of Experiments, viral clearance, and resin lifetime studies.
Michael Spade, Process Scientist, Purification Development, Johnson & Johnson/Centocor
Scaled-down laboratory models prove useful for generating prospective validation data in the development of biopharmaceuticals. These models are designed to mimic the manufacturing-scale process step and must be qualified before use. This presentation will discuss qualification of a scaled-down chromatography model and its subsequent use to generate process characterization/validation data including Design of Experiments, viral clearance, and resin lifetime studies.
Michael Spade, Process Scientist, Purification Development, Johnson & Johnson/Centocor
Importance of Analytics in Process Validation
2:30
Bioanalytical Characterization - A GPS for Effective Therapeutic Protein Process Development
Recombinant glycoproteins intended for therapeutic use may be complex in nature due to the presence of potential post-translational modifications, as well as overall primary, secondary, and tertiary structural features. The diversity of such attributes is defined by the manufacturing process. The earlier an evaluation of specific biochemical characteristics begins during process development, the better the understanding of the process design space, and implications for process refinement or change. Such data are also critical in defining a robust manufacturing process that would ensure product quality and consistency. In this presentation we will discuss applications of selected orthogonal analytical methods, such as carbohydrate profiling, capillary isoelectric focusing, and LC/MS, that may be used to support process development and product characterization.
John Harrahy, Ph.D., Senior Scientist, Bioanalytical Development, Genzyme Corporation
Recombinant glycoproteins intended for therapeutic use may be complex in nature due to the presence of potential post-translational modifications, as well as overall primary, secondary, and tertiary structural features. The diversity of such attributes is defined by the manufacturing process. The earlier an evaluation of specific biochemical characteristics begins during process development, the better the understanding of the process design space, and implications for process refinement or change. Such data are also critical in defining a robust manufacturing process that would ensure product quality and consistency. In this presentation we will discuss applications of selected orthogonal analytical methods, such as carbohydrate profiling, capillary isoelectric focusing, and LC/MS, that may be used to support process development and product characterization.
John Harrahy, Ph.D., Senior Scientist, Bioanalytical Development, Genzyme Corporation
3:00
Case
Study
Analytical Challenges for Process ValidationStudy
This talk will provide an overview of the strategies and infrastructure needed to achieve good analytical results for Process Validation. By demonstrating impurity clearance over the design space of the process we can minimize the need for testing of individual lots for impurities. Case studies on small scale purification models, protein carryover, sample tracking and stability, and information management will be given.
Martin Vanderlaan, MBA, Ph.D., Director, Analytical Operations, Genentech, Inc.
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 CMCBiotech 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 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 andTransfer 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 technolgy. 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 Facility and Logistical Challenges for Process Validation
Chairperson: Joydeep Ganguly, Associate Director, Manufacturing Sciences, Biogen Idec
10:15
Case
Study
Developing a Training Program for a New Facility and Linking it to Validation PracticesStudy
A well-trained and qualified workforce is one of the best ways for ensuring reproducible and consistent production in a complex biopharmaceutical facility. In this case study, we will discuss a structured learning program that was developed for a new large scale cell culture facility. The goal of this program was to provide staff with extensive hands-on experiences, as well as, detailed knowledge of the equipment, facilities, automation, and scientific/validation fundamentals. A major highlight of the program was the design and construction of a state-of-the-art process automation lab to provide staff with the opportunity to practice on real-life production scenarios.
Mayo Pujols, M.S., Director, Manufacturing, MedImmune, LLC.
10:45
The Evolution of Validating Process Transfers
Genentech's approach to process validation has evolved to meet the latest requirements and support transfers to our expanding internal and external manufacturing network. This talk will compare our historical approach to validating process transfers with the current practice and provide examples of both.
Amy Webb, Engineer, Late Stage Purification, Genentech, Inc.
Genentech's approach to process validation has evolved to meet the latest requirements and support transfers to our expanding internal and external manufacturing network. This talk will compare our historical approach to validating process transfers with the current practice and provide examples of both.
Amy Webb, Engineer, Late Stage Purification, Genentech, Inc.
11:15
Validation Challenges for an International Technology Transfer to a New Facility
Genentech recently completed the transfer of a commercial E. coli drug substance process to a new manufacturing facility in Singapore. Significant business drivers demanded an accelerated project timeline. The team overcame unexpected facility and logistical challenges to start GMP production less than 20 months after groundbreaking for the facility. Resolutions to issues encountered and lessons learned will be shared.
Judy Chang, M.S., Engineer II, Global Manufacturing Science and Technology, Genentech, Inc.
Genentech recently completed the transfer of a commercial E. coli drug substance process to a new manufacturing facility in Singapore. Significant business drivers demanded an accelerated project timeline. The team overcame unexpected facility and logistical challenges to start GMP production less than 20 months after groundbreaking for the facility. Resolutions to issues encountered and lessons learned will be shared.
Judy Chang, M.S., Engineer II, Global Manufacturing Science and Technology, 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
Amit Banerjee, Ph.D., Research Fellow, Global Biologics, Pfizer Inc.
Amit Banerjee, Ph.D., Research Fellow, Global Biologics, Pfizer Inc.
Upstream and Downstream Approaches to Process Validation
1:30
Case
Study
Development of a Design Space with Focus on Process Robustness for a Pre-Clinical Monoclonal Antibody Production ProcessStudy
A design space for an upstream cell culture process was developed at 2L bioreactor scale using using design of experiments. Critical process parameters were identified and linked to critical quality attributes of the drug substance post ProA purification. The data generated during design space development along with input from large scale manufacturing was used to determine acceptable process ranges.
Balrina Gupta, M.S., Associate Principal Scientist, Biological and Sterile Product Development, Schering Plough Research Institute
2:00
Case
Study
Selection of Critical Process Parameters and Identification of Proven Acceptable Ranges of an Upstream Process for a Monoclonal AntibodyStudy
The case-study provides an overview of the strategy and concepts of Roche for application of Quality by Design principles according to ICH Guidelines Q8, Q9 and Q10 in the process validation of an Upstream Process for a monoclonal antibody. The following main steps of this process and their advantages and limits are described and example data are given: * Scale down model application, focusing on engineering principles for developing scale down models and acceptance criteria for their qualification * Risk analysis according to FMEA principles for the selection and ranking of potential critical process parameters regarding * Process Characterization for the Selection of critical process parameters (CPPs) by DoE screening designs * Range Studies for the identification proven acceptable ranges (PARs) for critical process parameters by multivariate response surface designs.
Christian Hakemeyer, Ph.D., Manager, Fermentation/Pharmaceutical Biotech Development, Roche Diagnostics GmbH, Germany
2:30
Case
Study
Process Understanding - The Key to Successful Process ValidationStudy
Process understanding is derived from many sources including early process design experiments, process characterisation studies, technology transfer and scale-up activities. By leveraging process understanding and operational experience, effective control strategies can be developed for successful manufacture. In this presentation, approaches to gain process understanding will be discussed in the context of the application of risk management activities, the rational use of statistical experimental design and the integration of learning from previous Process Validation campaigns.
Mahesh Shivhare, Ph.D., Statistician, R&D, Avecia Biologics Ltd., United Kingdom
Graham McCreath, Ph.D., Head of Process Design, Avecia Biologics Ltd., United Kingdom
3:00
Networking Break in Exhibit/Poster Hall
Viral Validation Approaches
3:30
Virus Validation Using a Quality by Design (QbD) Strategy
Virus clearance is a Critical Quality Attribute (CQA) to Genentech antibody purification process. The presentation will discuss formal risk assessment leveraging platform viral clearance knowledge and characterization of the parameter ranges using Design of Experiment (DOE) approach, to support the Design Space of the purification process.
Bin Yang, Scientist, Late Stage Purification, Process Research & Development, Genentech, Inc.
Virus clearance is a Critical Quality Attribute (CQA) to Genentech antibody purification process. The presentation will discuss formal risk assessment leveraging platform viral clearance knowledge and characterization of the parameter ranges using Design of Experiment (DOE) approach, to support the Design Space of the purification process.
Bin Yang, Scientist, Late Stage Purification, Process Research & Development, Genentech, Inc.
4:00
Systematic Evaluation of Virus Removal by Parvovirus Nanofilters
Naonofiltration technology is routinely used in biotech industry to remove potential viral contaminants. We report here a systematic study in an attempt to better understand the technology and thus effectively mitigate the risk of virus breakthrough. The potential power of using information derived from scaled down lab model to obtain useful information is discussed.
Dayue Chen, Ph.D., Research Advisor, Bioproduct Research & Development, Lilly Research Laboratories, Eli Lilly and Company
Naonofiltration technology is routinely used in biotech industry to remove potential viral contaminants. We report here a systematic study in an attempt to better understand the technology and thus effectively mitigate the risk of virus breakthrough. The potential power of using information derived from scaled down lab model to obtain useful information is discussed.
Dayue Chen, Ph.D., Research Advisor, Bioproduct Research & Development, Lilly Research Laboratories, Eli Lilly and Company
4:30
Close of Conference
Bottom menu
Copyright IBC Life Sciences, a part of Informa Life Sciences Group. | Phone: 800.390.4078 | Email: reg@ibcusa.com