BEBPA PRESENTS:

2nd Annual US BEBPA Bioassay Conference

March 7-9, 2018
San Diego, CA

SPEAKERS

Abstracts (Alphabetical by Speaker/Presenter)

Converting an Enzymatic Potency Assay to a Relative Potency Assay

  • Speaker: Yeeling Chong, aTyr Pharma Inc.
  • Abstract: (Pending)
  • (Day 2: Bridging Assays Session)

Thaw-and-Use Target Cells Pre-Labeled with Calcein AM for Antibody Dependent Cell-Mediated Cytotoxicity Assays

  • Speaker: Shan Chung, Genentech
  • Abstract: (Pending)
  • (Day 2: New & Improved Technologies Session)

Reproducible, MoA-reflecting Reporter Based Bioassays to Enable Drug Development of Biosimilars and Biobetters

  • Speaker: Mei Cong, Promega
  • Abstract: (Pending)
  • (Day 1: Bioassays for BioSimilars Session)

Does it or Doesn’t it? Only the Assay Control Samples Know for Sure

  • Speakers: Stan Deming, Statistical Designs and Mike Sadick, Catalent
  • Abstract: (Pending)
  • (Day 1: Bioassays for Product Characterization Session)

Reference Materials, A Moving Target?

  • Speaker: Cindy Grant, Janssen R&D
  • Abstract: (Pending)
  • (Day 1: Reference Materials Session)

Bioassay Basics – What We (Should) Do in the Lab and Why

  • Instructors: Bassam Hallis, PHE and Jane Robinson, Consultant
  • Abstract: (Pending)
  • (Workshop1-AM)

The Role and Requirement of Bioassays in Assessing Analytical Similarity of Biosimilar Products to Reference Products

  • Speaker: Xu-Rong Jiang, AstraZeneca BioVentures
  • Abstract: (Pending)
  • (Day 1: Bioassays for BioSimilars Session)

An MOA Reflective Bioassay for a Bi-Specific Immuno-Oncology Product

  • Speaker: Hyun Jun Kim, AstraZeneca BioVentures
  • Abstract: (Pending)
  • (Day 2: Product Specific Bioassays Session)

AR BioAssay© – Clinically-Enabled Live Cell Assay for Pan-Androgen Measurement

  • Speaker: Irina Krylova, Xcellassay
  • Abstract: Living cells are exquisitely sensitive and accurate devises that constantly access their internal and external environment. However, they are rarely considered as tools for highly sensitive and reproducible measurements. Here we discuss a case study of a live cell assay, AR BioAssay that exhibits exquisite sensitivity, repeatability, accuracy, reproducibility, as well as inherent specificity, in measurement of androgenic compounds in human urine. We validated AR BioAssay against industry’s golden standard, mass-spectrometry, by conducting a limited clinical trial using urine from hypoandrogenic testosterone-supplemented men. This trial showed outstanding concordance between mass-spectrometry and AR BioAssay results, with correlation coefficient R2=0.98. Evaluation of the potency of AR BioAssay against a panel of 51 steroids showed outstanding specificity of AR BioAssay for intact androgens, either natural or synthetic. Unlike mass-spectrometry that can only measure a known compound in question, such as testosterone, AR BioAssay reports on the cumulative action of androgens that is of particular interest when assessing pan-androgenic status in children, women (in particular women diagnosed with polycystic ovary syndrome, PCOS), and prostate cancer patients. To our knowledge, this is the first example of highly accurate and reproducible clinically enabled live cell assay for measurement of biologically active compounds.
  • (Day 2: New & Improved Technologies Session)

Combining Run Results to Calculate Reportable Values

  • Speaker: Laureen Little, BEBPA
  • Abstract: (Pending)
  • (Day 2: Interactive Survey)

From Continuous to Thaw & Go….What’s in YOUR Bioassay

  • Instructors: Mike Merges and Mike Sadick, Catalent
  • Abstract: (Pending)
  • (Workshop 1-PM)

Development, Validation, and Implementation of an ELISA for Determining Potency of an Influenza Vaccine

  • Speaker: Michael Murphy, Medicago
  • Abstract: Medicago has developed a biomanufacturing platform that utilizes expression of recombinant proteins in the plant Nicotiana benthamiana. Our lead clinical product, quadrivalent seasonal influenza vaccine, consists of virus like particles (VLP) containing the influenza antigen hemagglutinin anchored in a plant lipid bilayer. Historically, the potency of seasonal influenza vaccine has been determined by the Single Radial Immunodiffusion (SRID) assay; however, this assay does not accurately predict the potency of the plant based seasonal influenza vaccine. Therefore, Medicago sought an alternative potency assay that was more predictive of immunogenicity. This objective led to the development of a strain specific Competitive ELISA potency assay that is stability indicating as shown by accelerated stability studies performed with Medicago’s vaccine and from an egg-based commercial vaccine. Upon transfer of the assay to the Quality Control organization, the assay was validated for potency determination of monovalent VLP Drug Substance and quadrivalent VLP Drug Product vaccine. Subsequently, the Competitive ELISA was successfully implemented for release, formulation, and stability testing of Medicago’s seasonal influenza vaccine.
  • Contributing Authors: Dan Hastings and Michael Murphy
  • (Day 2: Product Specific BioAssays Session)

Introduction to Statistics for Potency Bioassays

  • Instructors: Nancy Niemuth, Battelle and Ann Yellowlees, Quantics BioStatistics
  • Abstract: (Pending)
  • (Workshop 2)

Bioassays: the Past, the Present and the Future

  • Speaker: Jane Robinson, Consultant
  • Abstract: (Pending)
  • (Day 1: Opening Keynote Talk)

The Use of Surface Plasmon Resonance for Extended Biological Characterization

  • Speaker: Jeongsup Shim, Genentech
  • Abstract: (Pending)
  • (Day 1: BioAssays for Product Characterization Session)

USP Bioassay Chapters: Changes Afoot

  • Speaker: Robert Singer, R. Singer Consulting
  • Abstract: The suite of USP bioassay chapters has now seasoned for a few years. The chapters have been generally well-received and broadly implemented. Some of the bloom is off the rose now, though, and attention is being directed to some small thorns along the stem. Work on the chapters has been initiated at the USP, and this presentation will address that.
  • (Day 1: Pharmacopeia and the BioAssay Session)

Review of the New USP <1210>: Challenge and Opportunities

  • Speaker: Perceval Sondag, Pharmalex
  • Abstract: (Pending)
  • (Day 1: Pharmacopeia and the BioAssay Session)

Potency Assays for Immuno-Oncology Products

  • Speaker: Tara Stauffer, Bristol-Myers Squibb
  • Abstract: Bioassays are a critical component of immuno-oncology product development. Whether used for release and stability, biological characterization or to inform CMC development, the bioassay must reflect inherently complex systems and serve as a surrogate measure of the biological effect of the product. A high degree of bioassay accuracy and precision is required for product control strategy, in addition to the ability to discern molecular changes that influence structure-function relationships. The complexity of immuno-oncology mechanisms of action presents additional analytical challenges. Case studies addressing these challenges associated with the integral role of bioassay in immuno-oncology product development will be presented.
  • (Day 2: Product Specific Session)

Visualization and Assay Simulation Tools for the Verification of Equivalence Test Systems

  • Speaker: Ralf Stegmann, Stegmann Systems
  • Abstract: (Pending)
  • (Day 2: New & Improved Technologies Session)

Strategies for Bridging Late Phase Cell-Based Potency Assays

  • Speaker: Amy Teale, Regeneron Pharmaceuticals
  • Abstract: (Pending)
  • (Day 2: Bridging Assays Session)

Strategies for Functional Characterization of an IgG with Effector Function

  • Speaker: Max Tejada, Gilead
  • Abstract: (Pending)
  • (Day 1: BioAssays for Product Characterization Session)

Development of a Guinea Pig Potency Assay for a Next-Generation Anthrax Vaccine Candidate: Generation of a Stabilized Vaccine Reference Standard

  • Speaker: Daniel Tishkof, Emergent Biosolutions
  • (Day 1: Reference Materials Session)

Application of Droplet Digital PCR in Gene Therapy – A Case Study on Infectious Titer and Residual Host Cell DNA

  • Speaker: Yu Wang, Biogen
  • Abstract: (Pending)
  • (Day 2: New & Improved Technologies Session)

Statistical Approaches for Bridging Reference Lots

  • Speaker: Ann Yellowlees, Quantics Biostatistics
  • Abstract: (Pending)
  • (Day 1: Reference Materials Session)

Comparison of Recombinant Human FSH Produced by Ferring (REKOVELLE®) using In vivo Bioassay and In vitro Cell-based Assay

  • Speaker: Avi Zrachya, Bio-Technology General Ltd.
  • Abstract: Human follicle stimulating hormone (hFSH) stimulates the growth and recruitment of immature ovarian follicles in the ovary. Traditionally, therapeutic FSH preparations are calibrated by the Steelman-Pohley rat in vivo bioassay (Steelman and Pohley, 1953) and their activity is expressed in international units (IUs). However, the clinical program of the recombinant hFSH produced by Ferring (REKOVELLE®) is based on dosing by mass (in conjunction with AMH levels and body weight) and not on international units determined by the Steelman-Pohley rat bioassay.
    During the development of REKOVELLE®, the potency was determined by the in vivo bioassay to demonstrate consistency between batches (together with other quality attributes). Glycan profiling and capillary zone electrophoresis (CZE) were used for confirmation of consistency in glycosylation patterns and charged isoform distribution in the rFSH drug substance (DS).
    The potency of REKOVELLE® can be also determined by an in vitro cell-based assay developed by Ferring, using human embryonic kidney 293 (HEK 293) cells stably expressing the human FSH receptor (hFSH-R). In this model, REKOVELLE® activity is determined by direct measurement of intracellular cyclic adenosine mono phosphate (cAMP) accumulation upon binding of REKOVELLE® to the hFSH-R in reporter cells. The potency of REKOVELLE® is then determined as a function of the intracellular cAMP accumulation and relative to the assigned potency of the in-house reference standard. The in vitro cell-based assay was validated for REKOVELLE® drug product (DP) and DS.
    As part of the justification to replace the in vivo bioassay with the in vitro cell-based assay, the methods were compared by determining the potency of stressed-samples of REKOVELLE® and samples containing various levels of product-variants; several product-variants and stressed-samples act differently in both methods.
    In view of the results of this study and others the in vitro cell-based assay will replace the in vivo bioassay as a release test for determination of REKOVELLE® DS and DP potency; glycan profile and CZE will continue to confirm glycosylation and charged isoform distribution in REKOVELLE® DS.
  • (Day 2: Bridging Assays Session)

Case Study: Automating and Miniaturizing Cell-Based Assays

  • Speaker: TBA
  • Abstract: (Pending)
  • (Day 2: New & Improved Technologies Session)