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Top Ten List of Analytical Inadequacies in IND and BLA Submissions
Alfred Del Grosso
Team Leader, Analytical Chemistry
FDA/CBER

Regulatory Perspective on Comparability Assessments of Biotechnology Products
Audrey Jia, M.D., Ph.D.
Division of Monoclonal Antibodies
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Well Characterized Biologicals

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Ensure CMC Success through Novel Characterization Strategies and Regulatory Guidance

November 09-10, 2015 · Hyatt Regency Reston · Reston, VA

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Agenda

Agenda

Monday, November 9, 2015

7:00
Registration and Coffee

8:00
Opening Remarks John Alvino, Senior Manager, Global Regulatory CMC, AstraZeneca

Keynote Presentations

8:15
Zuben Sauna
New Data
Predicting and Circumventing the Immunogenicity of Therapeutic Coagulation Proteins Zuben Sauna, Principal Investigator, Laboratory of Hemostasis, Division of Hematology, CBER, FDA

9:00
Cara Fiore, Ph.D. Points to Consider for Serologic Assays Cara Fiore, Ph.D., Microbiologist, Master Reviewer, Division of Vaccines and Related Products Applications OVRR, CBER, FDA

Technology Workshops

9:45
Multiplexing Complementary Stability Measurements to Characterize and Screen Candidates and Formulations The stability and characterization of biologics are crucial steps in the development of modern medicines. Screening for and optimizing conditions used by biologics can increase long-term stability and manufacturability. Bringing these measurements into the pre-formulation stage de-risks development and aids in the selection of the optimum candidate. However, achieving this has been challenging for many years due to the lack of high-throughput, low sample consumption analytical tools. The Unit, a unique and pioneering stability platform from Unchained Labs, overcomes these inadequacies and allows researchers to develop stable proteins in optimal formulations which can be more easily manufactured and stored for longer. Daniel Lund, Product Manager, Unchained Labs

Improved De Novo Identification and Profiling of Disulfide Bonds in Biopharmaceuticals Including Analysis of DSB Scrambling The determination of disulfide bridges in biopharmaceuticals is a time-consuming process. The location of disulfide bridges (DSBs) in biologics, such as antibodies, affects their spatial structures and can impact their safety and efficacy. DSB analysis is therefore indispensable during the characterization of biologics. It is often performed by a time- intensive, data-processing approach, involving the comparison of peptide maps of reduced and non-reduced samples. In order to avoid this differential approach, a workflow analyzing non-reduced protein digests by LC-MALDI-MS/MS was investigated where the disulfide bonded peptides are reduced in the mass spectrometer. These Innovations in LC-MALDI MS and new processing software make it possible to determine disulfide linkages much faster and without prior knowledge about their positions (de novo). This method was applied to adalimumab, a likely target for biosimilar development. Additionally, a disulfide scrambling experiment was performed on adalimumab, and the results presented. Jason S. Wood, Ph.D., Market Manager, Pharmaceuticals and Biopharmaceuticals, Bruker Daltonics

10:15
Networking and Refreshment Break in Poster and Exhibit Hall

Track A

Analytical Methods
for Protein Therapeutics

10:55
Chairman's Opening Remarks Chris Barton, Senior Scientist, Analytical Biotechnology, MedImmune

11:00
Pall ForteBio Presentation Speaker TBD

11:30
Characterization of Poly-N-acetylactosamine Repeats in Biotheraputic Protein N-Glycosylation N- and O-glycosylation are common post-translational modifications on therapeutic proteins, and their characterization is an important part of product development. We present comprehensive glycosylation characterization of a therapeutic protein with 4 N- and 2 O-glycosylation sites, and evidence for poly-N-acetylactosamine (Gal - GlcNAc) repeats on N-glycosylation in this protein. The protein glycosylation profile was characterized by a range of techniques, including site specific analysis by peptide mapping and total glycan analysis with exoglycosidase sequencing by MALDI-TOF-MS/MS and HILIC-MS/MS. The protein was found to have a heterogeneous range of N-glycosylated structures, including bi-, tri- and tetra- antennary fucosylated cores. Extended Hex-HexNac additions on these cores, indicative of poly-N-acetylactosamine repeats, were also detected and further characterized by MS/MS analysis. This study thus represents a comprehensive analysis of N-glycosylation on a therapeutic protein, and describes a rare glycosylation motif which may decorate N-glycans. The potential implications of this motif will be considered. Chris Barton, Senior Scientist, Analytical Biotechnology, MedImmune

12:00
Analytical Methods for Protein Therapeutics Product quality attributes such as glycosylation, size and charge variants are critical characteristics for the development of biotherapeutics in mammalian cell culture processes in order to target a desired product profile. In an attempt to characterize the entire time-course of a fed-batch culture, a bioreactor autosampling system integrated with sample preparation and at-line instruments such as UPLC was developed to rapidly analyze the product quality changes in real time. This information can be rapidly translated for process control and enable process optimization based on desired product quality profiles. Ying Zhu, Associate Director, Cell Culture, Boehringer-Ingelheim

Track B

Assay Development Strategies
for Vaccines

10:55
Chairman's Opening Remarks Tara Stauffer, Senior Scientist, Bioassay Center of Excellence, Molecular and Analytical Development (MAD), Bristol-Myers Squibb

11:00
Measurement of Molecular Size Distribution of Glycoconjugate Vaccines by SEC-MALLS-RI
New Data
Bacterial polysaccharides conjugated to protein carriers (glycoconjugates) have been demonstrated to be effective to protect humans from invasive diseases. Molecular size of glycoconjugate vaccines is an important quality attribute that needs to be monitored during vaccine development, release and on stability. Size exclusion chromatography (SEC) with multiangle laser light scattering (MALLS) and refractive index (RI) detection has been used to measure molecular size of polysaccharides and glycoconjugates replacing the kD assay. Weight-average molecular mass (Mw), polydispersity, and the radius of gyration can be measured by this method with the most common reportable being Mw for molecular size distribution. Development of SEC-MALLS-RI methods is similar to the development of common SEC-UV methods with focus on the selection of SEC columns and mobile phases, while consideration of the compatibility of the column and the mobile phase with the MALLS detector is also important. In the cases of large glycoconjugates exceeding the upper limit of dynamic range of SEC columns, Asymmetric Flow Field Flow Fraction (AF4) with MALLS detection can be used for Mw measurement. Additionally, SEC-MALLS-RI can be extended to a three detector system with MALLS, RI and UV detection (SEC-MALLS-RI-UV) offers the possibility of calculating the concentrations of carrier protein and polysaccharide. This SEC-MALLS-RI-UV method has the potential to be an on-line and multi-attribute analytical tool for glycoconjugate vaccine analysis. Qian Wang, Principal Scientist, Analytical Research & Development, Pfizer

11:30
Bioassays for Immuno-Oncology: Unique Molecules, Unique Considerations
Case Study
Immuno-oncology therapeutics present unique challenges when developing QC suitable bioassays due to complex mechanisms of action. The translation of these challenges into workable solutions spans the lifetime of a molecule from assay development through commercial transfer. In this talk, we will focus on how the unique nature of immuno-oncology bioassays are addressed from a practical perspective. Tara Stauffer, Senior Scientist, Bioassay Center of Excellence, Molecular and Analytical Development (MAD), Bristol-Myers Squibb

12:00
Assay Development of Adjuvant Vaccine Formulation
Case Study
Characterization of vaccine candidates gets further complicated in presence of adjuvants. Case studies demonstrating approaches and lessons learned in assay development for adjuvant vaccines will be discussed. Kunal Bakshi, Senior Scientist, Pfizer

Luncheon Roundtable Discussions in Poster and Exhibit Hall

12:30
New!
Take a break from PowerPoint slides to discuss current challenges with your peers. Have one on one access to industry experts as you discuss the hottest topics. Sign-up sheets will be available at the registration desk on site. Each table is first come, first serve until each table is full.
  • Table A: How Similar is Similar Enough: Strategies for Proving Comparability
  • Table B: Predicting Immunogenicity for Biosimilars: What can be Correlated from the Originator Biologic
  • Table C: Assessing How Protein Aggregates and Sub-visible Particles Impact Immunogenicity
  • Table D: Strategies for Developing Bioassays Capable of Handling Complex Mechanisms of Action
  • Table E: Improving the Characterization of Proteins with Glycosylation
*Schedule subject to change

Track A

Analytical Strategies
for Diverse Products

1:25
Chairman's Opening Remarks Peter Day, Scientist, ADQC, Genentech

1:30
Analytical Characterization of Biologics for CEBR Diagnostic Products Testing, analysis, and process monitoring of pharmaceutical biologicals have been well discussed at these and other symposia. In contrast, biologics utilized in diagnostic assays have not been as well covered. These biologics are reviewed by regulatory bodies with similar requirements as pharmaceutical biologics. Diagnostic assays have additional challenges; for example in the pharmaceutical industry a product will have a single API biologic, whereas a diagnostic product can have as many as 24 unique biologics. Kevin Rupprecht, Ph.D., Principal Research Scientist, Core R&D, Analytical Chemistry, Abbott Diagnostics Division, Abbott Laboratories

2:00
Specific Gamma-Carboxylation Sites of a Recombinant Blood Factor are Critical for Coagulant Activity
Case StudyNew Data
Factor II (also called prothrombin) is the direct precursor to thrombin, a key enzyme in blood coagulation. Upon injury, factor II (FII) is converted to thrombin which then catalyzes the formation of blood clots. A critical requirement for the conversion of prothrombin to thrombin is the efficient gamma-carboxylation of glutamic acid residues (Gla) at the N-terminus of the protein. In this work the impact of missing Gla on the structure and function of recombinant FII was assessed by generating four site-specific mutants with missing Gla at amino acid positions 6, 14, 29 and 32. Gla content was confirmed by ion exchange chromatography and peptide mapping and coagulant activity, conformation and thermal stability were assessed. The results demonstrate a clear relationship between Gla content and recombinant FII coagulant activity. Further, like its endogenous counterpart, certain Gla sites were demonstrated to be more important for recombinant FII activity than others. David Spencer, Scientist, Biopharmaceutical Development, MedImmune

2:30
Impact of Sialic Acid Content on Potency
Case StudyNew Data
Terminal sialic acid (SA) of an antibody is known/reported to affect biological activity and serum half-life (i.e. PK). In this case study, we observed a strong negative correlation between SA content and in vitro potency of an Fc fusion protein (i.e. higher SA content results in lower potency). The in vitro potency assay developed for the Fc-fusion protein used in early clinical development measures the binding of the Fc fusion protein to a receptor extracellular domain (ECD). The strategy used to address this challenge will be discussed with focus on the impact of the reference standard SA content and the implementation of an SA correction factor for GMP lot release. Peter Day, Scientist, ADQC, Genentech

Track B

Methods for High-Throughput Analysis

1:25
Chairman's Opening Remarks Gloria Li, Manager, Process Development, Bristol-Myers Squibb

1:30
Summary of High Throughput Analytics in Process Development for Monoclonal Antibody and Fusion Protein Harmonized platform approach is the golden standard for monoclonal antibody and fusion protein sample analysis during process development. Sample purity, impurity and charge variants as well as process residuals are closely monitored during the upstream and downstream processes. This review intends to summarize the technique implemented and strategic evaluation of potential future evolution for a few key monitoring analytical methods. Discussion will include automation during purification of upstream samples or samples requiring buffer exchange; purity assays; monitoring of HMW and LMW impurities, aggregates; HCP, DNA, rProA; glycoslation and peptide mapping. Case studies will be shared in cases of LMW and HMW impurities, final product pink color issue as well as host cell protein monitoring et al during process development of IgG1 and IgG4 monoclonal antibodies. Gloria Li, Manager, Process Development, Bristol-Myers Squibb

2:00
Spotlight Presentation Secure your sponsored speaking slot by contacting Patty Rose at (508) 614-1672 or prose@ibcusa.com

2:30
A Platform Approach to Support Development and Lot-Release Testing of Ferritin Nanoparticle-Based Vaccines Jonathan W. Cooper, Ph.D., Staff Scientist, Analytical Development, Vaccine Production Program, Vaccine Research Center/NIAID/NIH

3:00
Networking and Refreshment Break in Poster and Exhibit Hall

Track A (continued)

Characterization of Novel Antibody Constructs

3:30
Analytical Strategies for Glycosylated Structures Alfred Del Grosso, Team Leader, Analytical Chemistry, Division of Biological Standards and Quality Control, CBER, FDA

4:00
USP Standards for Biological Medicines
New Data
USP maintains a broad and growing portfolio of standards in support of biological medicines products, these standards consist of both documentary and reference standards. This presentation will provide an overview of the most recent standard-setting initiatives for biologics with special focus on challenges associated with applying product-specific standards in the development of multi-manufacturer biologics. Fouad Atouf, Ph.D., Director, Biologics and Biotechnology, US Pharmacopeia

Characterization of Monoclonal Antibodies

4:30
The Devil You Know: Look Early, Look Hard And Minimize The Unexpected Developing even "standard" molecules such as monoclonal antibodies involves risk. A single seemingly innocuous point mutation can lead to unexpected behaviors that may not be detected until late in development. For example, high viscosity due a single point mutation introduced during humanization might only be detected in later stages of development, when a known dose and patient convenience requirements make high concentration necessary. Engaging with Research to apply carefully chosen developability assays combined with rigorous risk assessment criteria allows a risk assessment on molecules long before they transition into development. Low risk molecules may allow for expanded dosing options in phase 1 and subsequent trials, while high risk molecules could be re-engineered, mitigation strategies could be tested or the molecule could be treated more conservatively in terms of formulation and dosing strategies. In this talk I will outline some of the risk assessment assays and criteria Biogen has recently adopted. Mark Krebs, Ph.D., Senior Scientist, Protein Pharmaceutical Development, Biogen Idec

5:00
Improving the Degree of Specificity for the Characterization of mAbs James Bautista, Biologics Development Scientist, Bristol-Myers Squibb

Track B (continued)

Cell-Based Potency Assay Development

3:30
A Very Challenging Journey of Cell-Based Potency Assay Development, Transfer and Qualification Case Study
Case Study
Cell-based potency assays are considered to be the closest and most relevant measure of a biological mechanism of action. The current trend in the biopharma industry is to include cell-based potency assays even at earlier stages of product development. Cell-based potency assays are used for lot release and are often the early indicators of problems with product stability, impurities, and decreased potency. However, until current moment there is no clear regulatory guidance available for cell-based potency assays. It is partly because of the complexity of cell-base potency assays and their inherent high variability. As a case study, we will present the practices during one of our cell-based potency assay development, transfer and qualification. This presentation will address both technical and regulatory challenges in the absence of clear guidance for cell-based potency assays during the assay development, maintenance of quality control for the assay performance and establishment of acceptance criteria. Liming Shi, Senior Research Scientist, Eli Lilly and Company

4:00
Strategies for Determining the Right Stage Cell-Based Assay Development Santosh Nanda, Interdisciplinary Scientist, CBER, FDA (Invited)

Assay Development
for ADCs and Bispecifics

4:30
Analytical Challenges in the Development of Antibody-Drug Conjugates (ADCs) Jinhua Feng, Scientist, Biopharmaceutical Development, MedImmune

5:00
Qualification and Validation for the Characterization of ADCs Eric Jin, Senior Analytical Scientist, Pfizer

5:30
Networking Reception in Poster and Exhibit Hall

7:30
Close of Day One

Tuesday, November 10, 2015

7:30
Registration and Coffee

8:00
Opening Remarks Cara Fiore, Ph.D., Microbiologist, Master Reviewer, Division of Vaccines and Related Products Applications OVRR, CBER, FDA

Keynote Presentation

8:15
Shalini Gupta Immunogenicity Testing In an Evolving Industry Landscape This talk will highlight considerations and challenges for immunogenicity testing in the areas of novel biological therapeutics, biosimilars, changing industry business model and global expansion efforts. Shalini Gupta, Director Medical Sciences, Amgen

Regulatory Town Hall

9:00
New!
This town-hall style format gives attendees the opportunity to ask their questions concerning regulations for process variants and impurities, biologicals, biosimilars, and immunogenicity. Invited Speakers:
Cara Fiore, Ph.D., Microbiologist, Master Reviewer, Division of Vaccines and Related Products Applications OVRR, CBER, FDA
Amy Rosenberg, Director, Division of Therapeutic Proteins, CDER, FDA (Invited)
Marjorie Shapiro, Chief, Laboratory of Molecular and Developmental Immunology, FDA (Invited)
Robert Lionberger, Director, Office of Research and Standards, Office of Generic Drugs, FDA (Invited)
Michel Girard, Ph.D., Research Scientist, Centre for Vaccine Evaluation, Biologics and Genetic Therapies Directorate, Health Canada (Invited)

9:45
Networking and Refreshment Break in Poster and Exhibit Hall

Featured Presentation

10:15
Lokesh Bhattacharyya, Ph.D. Novel Approach to SE-HPLC to Characterize Molecular Size Distribution of Therapeutic Proteins Abstract not available at time of print. Lokesh Bhattacharyya, Ph.D., Lab Chief, Laboratory of Analytical Chemistry and Blood Related Products, Division of Biological Standards and Quality Control, CBER, FDA

Track A

Controlling Variants and Impurities

Testing the Impacts of Protein Variantson Immunogenicity

11:00
Comparability Assessment of Biotechnology Products
Case StudyNew Data
Forced degradation is a degradation of drug substance (DS) and drug product at conditions more severe than the accelerated conditions. It demonstrates the specificity of stability indicating methods and provides the insights into degradation pathways and degradation products. Comparability assessment demonstrates the quality and consistency of pre- and post-changes in products. Forced degradation study has been conducted on four different batches (batch# DS1, DS2, DS3, and DS4) of drug substance produced at three different manufacturing sites. DS batches were exposed to various stress conditions including agitation, heat, light, peroxide and high pH. These stresses were selected based on health authority's recommendation and our previous probing study on the molecule. Extensive analysis of the stressed samples indicate that all DS were sensitive to the light, peroxide, and high pH under the stress conditions applied in this study. Moderate degradation was observed upon heat stress. All DS were stable upon agitation stress. Santosh Yadav, Ph.D., Associate Principal Scientist, Sterile Product and Analytical Development, Merck

11:30
Orthogonal Measurements of Subvisible Particles
New Data
We compare measurements of subvisible particles using light obscuration, flow microscopy, electrical sensing zone (Coulter), and fluorescence photography. Using a custom microfluidic device that can perform the latter three simultaneously on each particle, we show that protein aggregates will result in very different sizes by the different methods if typical calibration beads are used to calibrate the measurement. The largest effect is due to the high degree of porosity of aggregates, which we measure and report, as well as particle shape, focus, and orientation effects. Results include measurements on stir-stressed NIST recombinant IgG1κ monoclonal antibody, microfabricated shape-controlled particles, and forthcoming reference fluoropolymer particles (ethylene tetrafluoroethylene, ETFE.) Results on conventional instruments will be reported and discussed in light of the findings from the microfluidic device measurements. Richard Cavicchi, Ph.D., Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology

12:00
Technology Workshops Opportunity to present the latest solutions and technologies for the characterization of biologicals. Please contact Patty Rose at 508-614-1406 or prose@ibcusa.com

Track B

Strategies for Proving Comparability

Strategies for Proving Comparability

11:00
Developing a Characterization Strategy for Proving Comparability with Biosimilars
Panel Discussion
As the first approved biosimilars hit the market, it is critical to understand how to establish comparability and strategies for demonstrating a high degree of similarity. This panel discusses the challenges with proving comparability and helps develop strategies to overcome those challenges Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
Athena Nagi, Director, Biologics Analytical Sciences, Merck
Jennifer Liu, Director, Analytical Sciences, Amgen

11:30
Carbohydrates Containing Biosimilars and Some of Our Future Challenges
New Data
The analysis of the glycoconjuagtes has become important for all comparability studies and in the quality control of therapeutic recombinant glycoproteins and polysaccharides. We will describe challenges in chromatography and new mass spectrometry methods and procedures that are used for glycoprotein and polysaccharide biosimilar analysis in order to obtain regulatory approval. Details will be given on the pros and cons of certain methods from regulatory stand point. We will discuss procedures necessary for the complete structural elucidation of heparin, low molecular weight heparin and antibody products. Challenges in comparability study of low molecular heparin will be discussed. Examples of the methodologies will include data needed in different phases and currents analysis of biosimilars. Parastoo Azadi, Ph.D., Technical Director, Complex Carbohydrate Research Center, University of Georgia

12:00
Technology Workshops Opportunity to present the latest solutions and technologies for the characterization of biologicals. Please contact Patty Rose at 508-614-1406 or prose@ibcusa.com

Luncheon Roundtable Discussions in Poster and Exhibit Hall

12:30
New!
Take a break from PowerPoint slides to discuss current challenges with your peers. Have one on one access to industry experts as you discuss the hottest topics. Sign-up sheets will be available at the registration desk on site. Each table is first come, first serve until each table is full.
  • Table A: Tactics for Identifying and Characterizing Contaminants
  • Table B: Handling Immunogenicity Concerns with Biosimilars
  • Table C: Streamlining the Approval Process: What Techniques are Most Useful in Minimizing the Time from Concept to Approval
  • Table D: De-Risking Immune Responses: How Much Risk Can Be Mitigated
  • Table E: Strategies for Minimizing the Occurrence of Variants and Contaminants
*Schedule subject to change

Track A (continued)

Analytical Methods for Identifying Product-Related Variants and Contaminants

1:40
Chairman's Opening Remarks Christopher Chumsae, Senior Scientist II, AbbVie Bioresearch Center

1:45
Host Cell Proteins: Nowhere to Run, Nowhere to Hide from Mass Spectrometry Detection Controlling for Host Cell Proteins (HCPs) in biotherapeutics is increasingly seen as critical to product quality, market perception, and faster product approval. Additionally, mass spectrometry and bioinformatics technology now available allows us to dig deeper and profile more extensively the content of a biotherapeutic product. In this presentation we show new work with large Biotechnology organizations on generic methodology for HCPs, and the process understanding and economic benefits that result. We also show how biopharmaceutical organizations have been able to adopt new technology without difficulty to complement their existing processes. We will also highlight new separations capabilities to help reduce sample preparation needs, providing faster method development and more robust assays. Eric Johansen, Ph.D., Global Scientific Manager, BioPharmaceutical Applications, AB Sciex

2:15
Optimizing Identification while Minimizing the Appearance of Contaminants Christopher Chumsae, Senior Scientist II, AbbVie Bioresearch Center

Technology Workshop

2:45
Comprehensive Identification and Quantification of Host Cell Proteins by Mass Spectrometry New advances in mass spectrometry allow for the direct identification and quantification of low levels of host cell proteins that copurify with biologics. Proteins in the low ppm range can be detected without removal of the drug substance, the use of antibodies or gel separation after manufacture in CHO, E. coli or yeast. Quantitative assays with labeled reference standards for each protein can then be rapidly constructed and used to monitor process improvements and consistency, as well as the effect of culture conditions, host strain and scale up. Case studies will be presented that demonstrate the utility of the approach and the importance of a dedicated assay for each biologic. Daniel Chelsky, Chief Scientific Officer, Research & Development, Caprion Sponsored by

3:15
Networking and Refreshment Break in Poster and Exhibit Hall

Characterization of Product
Variants and Impurities

4:00
Understanding the Impact of Product Variants Joseph Kotarek, Ph.D., ORISE Fellow, Office of Blood Research and Review, Division of Hematology, Laboratory of Plasma Derivatives, CBER, FDA (Invited)

4:30
Aggregation after administration of biotherapeutics in human plasma: possible implications for immunogenicity and toxicity
Development of not-aggregated formulations of biopharmaceutics is currently based on studies in the application container (e.g., vials, syringes). However, large aggregates may form when such not-aggregated formulations are mixed with human serum or blood. Thus, the formulation carries a definitive risk of adverse events due to sub-micron and micron-size aggregates, such as blocking of blood capillaries and increased immunogenicity.
Tudor Arvinte, Professor of Biopharmaceutics, University of Geneva, Switzerland and CEO, President, Therapeomic Inc.

Track B (continued)

Extrapolation of Indications

1:40
Chairman's Opening Remarks Jonathan Schiel, Research Chemist, National Institute of Standards and Technology

1:45
Supporting Bio IQs: Potential role of NIST Reference Materials During Biosimilarity Asessement
Case StudyNew Data
The target range for a given assay is often set based on data that have been collected from marketed lots of originator material, which typically encompass production history over multiyear time frame. Current best practices therefore focus on reverse engineering a molecule highly similar to the originators manufacturing capabilities. The availability of highly characterized, longitudinally available, and representative class-specific Reference Materials (e.g. NISTmAb RM 8671) may be a valuable tool for evaluating method performance during biosimilarity assessments. Recent development of qualified identity, quality, and stability-indicating methods for the NISTmAb RM 8671 will be discussed. Jonathan Schiel, Research Chemist, National Institute of Standards and Technology

2:15
Spotlight Presentation Secure your sponsored speaking slot by contacting Patty Rose at (508) 614-1672 or prose@ibcusa.com

2:45
Establishing Comparability Across Indications Athena Nagi, Director, Biologics Analytical Sciences, Merck

3:15
Networking and Refreshment Break in Poster and Exhibit Hall

Overcoming Challenges
with Interchangeability

4:00
Assessing How Comparability Affects Interchangeability Jennifer Liu, Director, Analytical Sciences, Amgen

4:30
Understanding the Impact of Interchangeability, Where Do We Go From Here? Graham McPherson, Head of Analytical, Biosimilar Drug Products, Sandoz

5:00
Close of Conference

Charles River