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Well Characterized Biologicals
Event Information
アジェンダ
7:45
Registration and Coffee
8:40
Chairperson's Welcome and Opening Remarks
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group
Evolving Paradigms in Biopharmaceutical Products: New and Legacy Products
(バイオ医薬品におけるパラダイムの展開：新製品と伝統的製品)
8:45
Common Mistakes Seen in Phase 1/2 CMC Studies
Typically, the primary CMC focus for IND-enabling studies is to minimize product safety risks during first-in-human trials. But in order to best position the CMC package for the end of Phase 2, there are several additional elements that should be considered. Numerous CMC activities performed during Phase 1 and 2 can be strategically designed to efficiently support late phase studies. And, if performed in alignment with ICHQ10 'knowledge management' principles, they add considerable value to late-phase partnering or licensing/acquisitions. This presentation will highlight several common CMC mistakes made during early development, as observed from over two decades of experience with both small and large biotech organizations, and a wide variety of biopharm products.
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group
Typically, the primary CMC focus for IND-enabling studies is to minimize product safety risks during first-in-human trials. But in order to best position the CMC package for the end of Phase 2, there are several additional elements that should be considered. Numerous CMC activities performed during Phase 1 and 2 can be strategically designed to efficiently support late phase studies. And, if performed in alignment with ICHQ10 'knowledge management' principles, they add considerable value to late-phase partnering or licensing/acquisitions. This presentation will highlight several common CMC mistakes made during early development, as observed from over two decades of experience with both small and large biotech organizations, and a wide variety of biopharm products.
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group
9:15
Case
Study
An Integrated Assessment for Early Product DevelopmentStudy
Early identification of the potential risks associated with the development of protein therapeutics can result in significant time and cost savings. This talk will show how an integrated assessment early in product development has identified key degradation pathways and the related risks. This early assessment is used to develop the most viable drug candidates and inform future development work.
David Spencer, Scientist I, Analytical Biochemistry, MedImmune, Inc.
New, Unpublished Data
9:45
Detecting and Quantifying Low Level Sequence Variants and Post-Translational Modifications
Abstract not available at time of print.
Dingyi Wen, Ph.D., Principal Scientist, Analytical Biochemistry, Biogen Idec, Inc.
Abstract not available at time of print.
Dingyi Wen, Ph.D., Principal Scientist, Analytical Biochemistry, Biogen Idec, Inc.
10:15
Networking Refreshment Break
New, Unpublished Data
10:45
Case
Study
A Case Study: Characterization of a Legacy Protein Therapeutic to Meet 21st Century RequirementsStudy
The challenges involved in characterizing a legacy protein therapeutic, with a manufacturing process originally developed 30 years ago, will be discussed. Fermentation of the native microorganism is followed by multiple purification steps. In order to obtain licensure in new territories, new state of the art analytical methodologies were required to clearly define the role of purification steps, and to confirm that the process, although utilizing older technologies, was able to generate highly consistent drug substance high purity.
John Brehm, Ph.D., Scientific Program Manager, Centre for Emergency Preparedness, Health Protection Agency, United Kingdom
11:15
Modernizing Assays for Legacy Products
Abstract not available at time of print.
Ashutosh Rao, Ph.D., Product Quality Reviewer, Division of Therapeutic Proteins, CDER, US FDA
Abstract not available at time of print.
Ashutosh Rao, Ph.D., Product Quality Reviewer, Division of Therapeutic Proteins, CDER, US FDA
11:45
Q&A Panel Discussion with Morning Speakers
12:15
Networking Luncheon
Strategic Discussion Sponsorship Opportunity
Does your company have an exciting technology or approach for protein product characterization? Would you be interested helping to shape a discussion session or workshop at this conference on a topic of your choosing related to characterization strategies for biologicals? Please contact Jennifer Thebodo at jthebodo@ibcusa.com for more information on sponsoring a strategic discussion or workshop during this lunch break and other times during the conference.
Does your company have an exciting technology or approach for protein product characterization? Would you be interested helping to shape a discussion session or workshop at this conference on a topic of your choosing related to characterization strategies for biologicals? Please contact Jennifer Thebodo at jthebodo@ibcusa.com for more information on sponsoring a strategic discussion or workshop during this lunch break and other times during the conference.
Characterizing Complex Antibody Products - Brave New Worlds
(複合抗体製品の特性化：勇敢な新しい世界)
New, Unpublished Data
1:30
Analytical Challenges Characterizing Size Variants of an Auristatin Based Antibody-Drug Conjugate
Abstract not available at time of print.
Adam Fung, Ph.D., Scientist, Analytical Biochemistry and Formulations, Seattle Genetics
Abstract not available at time of print.
Adam Fung, Ph.D., Scientist, Analytical Biochemistry and Formulations, Seattle Genetics
New, Unpublished Data
2:00
Characterization Strategies for Antibody-Maytansinoid Conjugates
Antibody-Maytansinoid Conjugates (AMCs) are immunoconjugates that consist of antibodies with multiple molecules of a maytansinoid cytotoxic agent attached. By using well-designed processes, AMCs can be manufactured very consistently. However, these manufacturing processes inherently introduce additional heterogeneity into the immunoconjugate, beyond that already present in the antibody. Process, analytical and regulatory strategies for addressing this heterogeneity will be discussed.
Godfrey Amphlett, Ph.D., Vice President, Process and Analytical Development, ImmunoGen, Inc.
Antibody-Maytansinoid Conjugates (AMCs) are immunoconjugates that consist of antibodies with multiple molecules of a maytansinoid cytotoxic agent attached. By using well-designed processes, AMCs can be manufactured very consistently. However, these manufacturing processes inherently introduce additional heterogeneity into the immunoconjugate, beyond that already present in the antibody. Process, analytical and regulatory strategies for addressing this heterogeneity will be discussed.
Godfrey Amphlett, Ph.D., Vice President, Process and Analytical Development, ImmunoGen, Inc.
New, Unpublished Data
2:30
Case
Study
Characterization of Sym004: a Combination of Two Monoclonal Antibodies Targeting the Egf ReceptorStudy
Combinations of antibodies and antibody mixtures are presently being evaluated as drug candidates to treat serious indications especially within the oncology field. We have developed an antibody mixture, Sym004, a product consisting of two monoclonal antibodies targeting EGFR, which is currently being evaluated in clinical trials. This presentation will outline the characterization strategy that has been established to address analytical challenges of antibody mixtures relative to monoclonal products.
Frank Nygaard, Ph.D., Senior Scientist, Symphogen A/S, Denmark
3:00
Networking Refreshment Break
New, Unpublished Data
3:30
Case
Study
Ang2-VEGF CrossMAb: Development and Characterization of a Novel Bispecific Human IgG1 Antibody to Treat Solid TumorsStudy
The talk describes the successful expression of a new format for a 1+1-bi-specific antibody called CrossMab. The combination of the knob-into-hole technology and the crossover of the CH1 and CL domain on one side of the bispecific antibody allows the generation of cell lines producing the CrossMab with high titer and excellent quality. Development of the production process and analytical characterization of the CrossMab will be presented.
Kay Stubenrauch, Ph.D., Senior Scientist, Biologics Research, Roche, Germany
4:00
Characterization Strategies for Complex Biologics
Abstract not available at time of print.
Jee Chung, Ph.D., Biologist, Division of Therapeutic Proteins, CDER, US FDA
Abstract not available at time of print.
Jee Chung, Ph.D., Biologist, Division of Therapeutic Proteins, CDER, US FDA
4:30
Characterization of Cell and Gene Therapy Products
Abstract not available at time of print.
Lilia Bi, Ph.D., Biologist/Reviewer, Division of Cellular and Gene Therapies, CBER, US FDA
Abstract not available at time of print.
Lilia Bi, Ph.D., Biologist/Reviewer, Division of Cellular and Gene Therapies, CBER, US FDA
5:00
Q&A Panel Discussion with Afternoon Speakers
5:30
Close of Day One
8:10
Chairperson's Remarks
Carl Co, Ph.D., Scientist, Genentech, Inc.
Carl Co, Ph.D., Scientist, Genentech, Inc.
New Approaches with Functional Assays for Biologicals
(生物製剤の機能的アッセイによる新たなアプローチ)
New, Unpublished Data
8:15
Case
Study
Design of Experiments (DOE) for Potency Assay OptimizationStudy
Abstract not available at time of print.
Abhishek Mathur, Ph.D., Senior Scientist, Biological Characterization, Amgen, Inc.
New, Unpublished Data
8:45
Case
Study
A Strategy for Assessing Fc Effector Functionality and Novel Bioassays for Monitoring of Antibody Effector FunctionsStudy
Abstract not available at time of print.
Kendall D. Carey, Ph.D., Scientist II, Analytical Biochemistry, MedImmune, Inc.
9:15
Case
Study
Assessment of Functional Activity of Monoclonal AntibodiesStudy
Abstract not available at time of print.
Tatjana Matejic, Ph.D., Associate Research Fellow, Analytical Research and Development, Pfizer, Inc.
9:45
Networking Refreshment Break and Exhibit/Poster Viewing
New, Unpublished Data
10:30
Case
Study
Use of AlphaScreen and OCTET Red to Assess FcγR(s) and FcRn BindingStudy
Several case studies will be presented which highlight the relative merits and use of FcγRs and FcRn binding assays based on AlphaScreen and OCTET Red technologies. A correlation between FcγRs binding and ADCC activity will also be presented.
Carl Co, Ph.D., Scientist, Genentech, Inc.
Vaccine and Protein Characterization and Comparability
(ワクチンとタンパク質の特性化と比較可能性)
11:00
Serological Assessment of Vaccine Effectiveness
Abstract not available at time of print.
Cara Fiore, Ph.D., Microbiologist, Regulatory Scientist, Division of Vaccines and Related Products Applications, Office of Vaccines Research & Review, CBER, US FDA
Abstract not available at time of print.
Cara Fiore, Ph.D., Microbiologist, Regulatory Scientist, Division of Vaccines and Related Products Applications, Office of Vaccines Research & Review, CBER, US FDA
11:30
Characterization of Therapeutic Vaccines
Elena Gubina, Ph.D., Reviewer and Expert Biologist, Division of Cellular and Gene Therapies, CBER, US FDA
Elena Gubina, Ph.D., Reviewer and Expert Biologist, Division of Cellular and Gene Therapies, CBER, US FDA
12:00
Networking Luncheon and Exhibit/Poster Viewing
1:10
Chairperson's Remarks
Steven L. Giardina, Ph.D., Director, Process Analytics/Quality Control, Biopharmaceutical Development Program, SAIC-Frederick, Inc.
Steven L. Giardina, Ph.D., Director, Process Analytics/Quality Control, Biopharmaceutical Development Program, SAIC-Frederick, Inc.
New, Unpublished Data
1:15
Case
Study
Biophysical Characterization of Vaccines: In Reference to Chikungunya Virus VLP VaccineStudy
We develop vaccines against different diseases caused by pathogens such as HIV, Influenza, Chikungunya, Ebola and Marburg using a variety of state-of-the-art analytical tools for vaccine characterization and assay development. Some of these assays can also be used for accelerated stability testing, stress studies, and forced degradation studies of the vaccines. These assays can help in performing in-depth biophysical characterization and may be used for screening optimal formulation conditions for a given vaccine. We will present data on the characterization of CHIKV VLP vaccine using some of these techniques.
Indresh K. Srivastava, Ph.D., Director, Purification and Analytical Development, Vaccine Production Program Laboratory, Vaccine Research Center, NIAID,National Institutes of Health
New, Unpublished Data
1:45
Case
Study
Comparability Assessment of a MAb after Clone and Process ChangesStudy
To improve cell culture consistency and cell productivity, the clone and cell culture processes of a recombinant MAb product were changed between Phase I/II and Phase III manufacturing. These changes introduced marked differences in product size and charge variant distribution. A new size variant was observed in both SEC and non-reduced CE-SDS methods. The characterization results suggested that the new size variant was an antibody fragment. This talk will present the characterization of the differences between products produced from different processes and the assessment of product comparability.
Connie Lu, Ph.D., Scientist, Protein Analytical Chemistry, Genentech, Inc.
New, Unpublished Data
2:15
Case
Study
Assessment of Process Residuals using Commercial AssaysStudy
The National Cancer Institute has been developing a chimeric monoclonal antibody, ch14.18, for over a decade for the treatment of pediatric neuroblastoma. Multiple lots of product using hollow-fiber technology have been manufactured to keep pace with demand, making lot-to-lot comparability a continuing product quality issue. This case study focuses on the challenges associated with using commercially available kits for tracking the removal of product-related impurities, in particular host cell proteins and bovine serum albumin.
Steven L. Giardina, Ph.D., Director, Process Analytics/Quality Control, Biopharmaceutical Development Program, SAIC-Frederick, Inc.
2:45
Networking Refreshment Break and Exhibit/Poster Viewing
3:15
Regulatory Perspectives on Comparability of Biotechnology Products
Ruth Cordoba-Rodriguez, Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies, CDER, US FDA
Ruth Cordoba-Rodriguez, Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies, CDER, US FDA
Biosimilars and Similarity
(バイオシミラーと類似性)
3:45
Challenges in Establishment of Biosimilarity: An Approach with Rational Scientific Justification
Abstract not available at time of print.
Kimberly May, Ph.D., Associate Director, Merck & Co.
Abstract not available at time of print.
Kimberly May, Ph.D., Associate Director, Merck & Co.
New, Unpublished Data
4:15
Case
Study
Assessment of Protein Structure Similarity by Nuclear Magnetic Resonance Spectroscopy: Applications to Biosimilars and ManufacturingStudy
Demonstration of structural comparability for biologics and biosimilars is a requirement for product submissions to regulatory agencies. Analytical techniques that examine the overall fold and chemical integrity of biomolecules are commonly used. Additional high order structural information with atomic resolution can be obtained through NMR spectroscopy. The use of NMR methods to compare protein structures to support development of biosimilars and to determine the impact of manufacturing process changes will be discussed.
Carlos Amezcua, Ph.D., Research Scientist, Technology Resources, Baxter Healthcare Corporation
4:45
Q&A Panel Discussion with Afternoon Speakers
5:15
Close of Day Two
8:10
Chairperson's Remarks
Dirk Chelius, Ph.D., Head of Mass Spectrometry, Process Sciences & Production, Novartis Pharma AG, Switzerland
Dirk Chelius, Ph.D., Head of Mass Spectrometry, Process Sciences & Production, Novartis Pharma AG, Switzerland
Novel Analytical Technology Implementation
(新規の分析技術の導入)
8:15
Quantification of Posttranslational Modifications in Recombinant Proteins Using Stable Isotope Labeled Internal Standard and Mass Spectrometry
With the implementation of Quality by Design concept to biopharmaceutical drug development, there is a demand for accurate quantification of Critical Quality Attributes during the product lifecycle. We have developed a method to quantify the posttranslational modifications in recombinant proteins using Stable Isotope Labeled Internal Standards (SILIS) and MS. Several examples using microbial and mammalian expressed recombinant proteins will be shown to demonstrate the advantages of this approach, which include superior accuracy and precision.
Gang Huang, Ph.D., Principal Scientist, Process and Product Development, Amgen, Inc.
With the implementation of Quality by Design concept to biopharmaceutical drug development, there is a demand for accurate quantification of Critical Quality Attributes during the product lifecycle. We have developed a method to quantify the posttranslational modifications in recombinant proteins using Stable Isotope Labeled Internal Standards (SILIS) and MS. Several examples using microbial and mammalian expressed recombinant proteins will be shown to demonstrate the advantages of this approach, which include superior accuracy and precision.
Gang Huang, Ph.D., Principal Scientist, Process and Product Development, Amgen, Inc.
8:45
Fully Automated N-glycoslyation Analysis of Monoclonal Antibodies
The standard method for the analysis of glycosylation of monoclonal antibodies at Novartis includes enzymatic cleavage by PNGase F of 2AB labeled glycans followed by liquid chromatography and fluorescence detection. This time consuming method was compared to a high-speed fully automated analysis of N-glycans on a microfluidic LC-MS chip device. Validation parameters of this new technology will be presented and compared to the standard method.
Dirk Chelius, Ph.D., Head of Mass Spectrometry, Process Sciences & Production, Novartis Pharma AG, Switzerland
The standard method for the analysis of glycosylation of monoclonal antibodies at Novartis includes enzymatic cleavage by PNGase F of 2AB labeled glycans followed by liquid chromatography and fluorescence detection. This time consuming method was compared to a high-speed fully automated analysis of N-glycans on a microfluidic LC-MS chip device. Validation parameters of this new technology will be presented and compared to the standard method.
Dirk Chelius, Ph.D., Head of Mass Spectrometry, Process Sciences & Production, Novartis Pharma AG, Switzerland
Technology Workshop
9:15
Early prediction of how a candidate therapeutic protein will behave during manufacture and storage over extended periods has always been highly desirable to help identify optimum candidates and reduce development risks. As the biopharmaceutical industry begins to move beyond relatively well understood protein formats like mAbs this is becoming increasingly critical as many of the exciting new formats are proving 'troublesome' or at the very least less predictable. This presentation will review some of the analytical 'clues' to a protein's suitability for subsequent manufacture and long term storage. This will include some commonly used stability indicators and some more speculative ideas with a particular focus on measurements which can be made rapidly and early in development.
Simon Webster, Ph.D., Chief Scientific Officer, Avacta Limited, United Kingdom
9:45
Networking Refreshment Break and Exhibit/Poster Viewing
Technology Workshop
10:15
Enabling Technologies for Characterization of Biologicals: Label-Free Analysis of Active Concentration and Stability
Biacore™ and MicroCal™ systems enable label-free protein interaction analysis, generating unique data on the interactions between proteins and other biomolecules. Biacore™ systems enable elucidation of the speed (kinetics) and strength (affinity) of protein interactions, as well as active concentration with or without a reference standard. MicroCal™ DSC systems enable measurement of the stability of biotherapeutics. Together these systems provide comprehensive characterization of biotherapeutics enabling critical decisions needed for confident lot release.
Michael B. Murphy, Ph.D., Senior Application Scientist, GE Healthcare Life Sciences
Biacore™ and MicroCal™ systems enable label-free protein interaction analysis, generating unique data on the interactions between proteins and other biomolecules. Biacore™ systems enable elucidation of the speed (kinetics) and strength (affinity) of protein interactions, as well as active concentration with or without a reference standard. MicroCal™ DSC systems enable measurement of the stability of biotherapeutics. Together these systems provide comprehensive characterization of biotherapeutics enabling critical decisions needed for confident lot release.
Michael B. Murphy, Ph.D., Senior Application Scientist, GE Healthcare Life Sciences
New, Unpublished Data
10:45
An Examination of LC/MS-Based Approaches for Host Cell Protein Characterization
While traditional HCP ELISA allows relative quantification of bulk HCPs, the technique offers no information on quantities or identities of individual HCPs. This presentation details efforts to apply methods including online 2-D LC/MSn, as well as offline HCP enrichment to better inform the impurity profiles of biological products.
Matthew R. Schenauer, Ph.D., Postdoctoral Fellow, Analytical and Formulation Sciences, Amgen, Inc.
While traditional HCP ELISA allows relative quantification of bulk HCPs, the technique offers no information on quantities or identities of individual HCPs. This presentation details efforts to apply methods including online 2-D LC/MSn, as well as offline HCP enrichment to better inform the impurity profiles of biological products.
Matthew R. Schenauer, Ph.D., Postdoctoral Fellow, Analytical and Formulation Sciences, Amgen, Inc.
11:15
A Regulatory Perspective on Reference Standard Establishment and Life-Cycle Management
Abstract not available at time of print.
Carla SR Lankford, M.D., Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies, CDER, US FDA
Abstract not available at time of print.
Carla SR Lankford, M.D., Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies, CDER, US FDA
11:45
Lunch on your own
1:10
Chairperson's Remarks
Joseph Kutza, Ph.D., Director, CMC Regulatory Affairs, MedImmune, Inc.
Joseph Kutza, Ph.D., Director, CMC Regulatory Affairs, MedImmune, Inc.
Visible/Subvisible Particulates and Aggregates
(肉眼で見える／見えない粒子と凝集体)
New, Unpublished Data
1:15
Understanding and Correcting Biases in Optical Detection of Subvisible Particles
The optical measurement of protein particulates is challenging because of their low optical contrast and unusual morphology. I will discuss measurement biases that occur for dynamic microscopy and light obscuration methods, as well as the development of new standards and methods to measure and correct for these biases.
Dean C. Ripple, Ph.D., Leader, Bioprocess Measurements Group, National Institute of Standards and Technology
The optical measurement of protein particulates is challenging because of their low optical contrast and unusual morphology. I will discuss measurement biases that occur for dynamic microscopy and light obscuration methods, as well as the development of new standards and methods to measure and correct for these biases.
Dean C. Ripple, Ph.D., Leader, Bioprocess Measurements Group, National Institute of Standards and Technology
1:45
Protein Particulates - Recent Advances and a Case Study
This talk will discuss recent advances in detection of protein particulates, and characterization techniques in efforts to understand mechanism of particulate formation. A case study will also be presented.
Tapan K. Das, Ph.D., Senior Principal Scientist, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.
This talk will discuss recent advances in detection of protein particulates, and characterization techniques in efforts to understand mechanism of particulate formation. A case study will also be presented.
Tapan K. Das, Ph.D., Senior Principal Scientist, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.
New, Unpublished Data
2:15
Case
Study
Sorting Subvisible Protein Particles from Silicone Oil in the 500 nm to 5 µm RangeStudy
Characterizing subvisible particles in the entire size range remains a challenge. Here, a novel method that relies on differences in particle buoyant mass is used to count and size particles in the 500 nm - 5 mm range demonstrating its ability to distinguish between silicone oil droplets and protein particles in a size range that is especially challenging. In addition, light obscuration and flow microscopy are used as complementary methods to evaluate high concentration mAb in prefilled syringes on accelerated stability.
Ankit R. Patel, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.
2:45
Networking Refreshment Break and Last Chance for Exhibit/Poster Viewing
New, Unpublished Data
3:15
The Use of Flow Cytometry for the Detection of Subvisible Particles in Therapeutic Protein Formulations
The amount, identity and size distribution of particles in parenteral therapeutic protein formulations is of immense interest due to potential safety and efficacy-related implications. Application of a flow cytometer, equipped with forward- and side-scattering as well as fluorescence detectors, to determine the number of subvisible particles in monoclonal antibody formulations will be described. This approach is characterized by protein aggregate selectivity, sub-micron detection limit, small sample amounts and high throughput. The use of the method to minimize purity and immunogenicity concerns will be discussed, and challenges of further analytical advancements outlined.
Henryk Mach, Ph.D., Senior Investigator, Vaccine Formulation and New Technology Development, Merck Research Laboratories
The amount, identity and size distribution of particles in parenteral therapeutic protein formulations is of immense interest due to potential safety and efficacy-related implications. Application of a flow cytometer, equipped with forward- and side-scattering as well as fluorescence detectors, to determine the number of subvisible particles in monoclonal antibody formulations will be described. This approach is characterized by protein aggregate selectivity, sub-micron detection limit, small sample amounts and high throughput. The use of the method to minimize purity and immunogenicity concerns will be discussed, and challenges of further analytical advancements outlined.
Henryk Mach, Ph.D., Senior Investigator, Vaccine Formulation and New Technology Development, Merck Research Laboratories
New, Unpublished Data
3:45
Case
Study
Characterizing Stability Changes in a Human Monclonal IgG Antibody That Result in an Increase in OpalescenceStudy
A significant increase in opalescence was observed for a human monoclonal IgG2 antibody manufactured at Pilot scale. Stability results showed an acidic shift in the charge profile from time zero and a significant decrease in potency after 6 months. Peptide mapping revealed the acidic variants contain a higher level of a deamidated light chain peptide. In this study, the physical and chemical changes occurring in the antibody on stability that could result in an increase in opalescence are investigated.
Esohe Idusogie, Ph.D., Associate Director, Process Development Analytical, OncoMed Pharmaceuticals
New, Unpublished Data
4:15
Case
Study
Approaches for Evaluating the Impact of Mechanical Stress on Therapeutic ProteinsStudy
This talk will present a case study on the identification, optimization, and characterization of an appropriate mechanical stress methodology for comparability studies. A wide range of analytics, with a focus on sub-visible particles and solution turbidity, were employed to evaluate the stability impact and determine the variability of the mechanical stress methodology.
Nicholas Guziewicz, Staff Scientist, BioFormulations Development, Genzyme Corporation
4:45
Analytical Techniques for Detection, Quantification and Characterization of Protein Aggregates in Biological Products
Abstract not available at time of print.
Ewa Marszal, Ph.D., Chemist, Laboratory of Plasma Derivatives, Division of Hematology, CBER, US FDA
Abstract not available at time of print.
Ewa Marszal, Ph.D., Chemist, Laboratory of Plasma Derivatives, Division of Hematology, CBER, US FDA
5:15
Close of Conference
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