Keynote Presentation

Jan 1, 2020 1:30pm ‐ Jan 1, 2020 1:30pm

Identification: R106

Analytics play a critical role in assuring product quality through release testing, process control, deep characterization, defining critical quality attributes, comparability and analytical similarity. A framework that would facilitate the use of this information and allow for effective knowledge management will enhance quality control strategies and drug development. This concept is explored. Bioassays are a key part of analytics for quality; Such assays and biological models in general can also facilitate effective clinical development of drugs. Communication and structures that leverage biology across disciplines may enhance drug development.

Taking Your Bioassay to the Next Level: Phase Appropriate Validation of Bioassays for Use in GMP Sample Analyses

Apr 27, 2020 7:00am ‐ Apr 27, 2020 7:00am

This session is only available to those who purchased it in advance

Technical Aspects of Bioassays throughout the Product

Apr 27, 2020 9:45am ‐ Apr 27, 2020 1:30pm

Identification: MondayGS

The technical aspects of bioassay strategies are essential as ever while the biotech industry launches new biologics including modified proteins, DNA, RNA and cell-based therapeutics. The focus of this session will reinforce the importance of those bioassay technical features that contribute to the successful performance of a bioassay from assay development through to the post-marketing stage. Some of the common threads intersecting bioassay applications and strategies that will be discussed during this session include bioassay design considerations, critical reagents (e.g. reference standards), data analysis approaches, and control measures used throughout the product lifecycle.

Welcome and Introduction

Apr 27, 2020 10:00am ‐ Apr 27, 2020 10:10am

Identification: M101

Robo Meets DoE

Apr 27, 2020 10:10am ‐ Apr 27, 2020 10:35am

Identification: M102

DoE is a crucial part during the development of potency assays at the Potency Assay Skill Center of Boehringer Ingelheim. The DoE approach is accelerating assay development as it allows the combination of several development experiments in one set. Therefore the total number and extend of assay runs needed is significantly reduced. Furthermore, it increases assay quality as it e.g. helps to identify 2-factor interactions which are only hardly detectable with the OFAT (one factor at the time) approach. Automation of DoEs is done to reduce variability of potency assays which improves the output of the DoEs. The process of DoE automation was split into two parts: Semi-automation of pipetting steps have been introduced in DoE experiments by using automated electronic multichannel pipettes. To further minimize handling time and to improve the assay throughput, fully automation of DoE by using an automation workstation is being established. Opportunities and challenges of the semi and fully automated DoE approaches will be shown.

Critical Reagents in Bioassay: Their Importance, Characterization and Storage

Apr 27, 2020 10:35am ‐ Apr 27, 2020 11:00am

Identification: M103

The technical aspects of bioassay strategies are essential as ever while the biotech industry launches new biologics including modified proteins, DNA, RNA and cell-based therapeutics. The focus of this session will reinforce the importance of those bioassay technical features that contribute to the successful performance of a bioassay from assay development through to the post-marketing stage. Some of the common threads intersecting bioassay applications and strategies that will be discussed during this session include bioassay design considerations, critical reagents (e.g. reference standards), data analysis approaches, and control measures used throughout the product lifecycle.

Biological Reference Standards for Multivalent Vaccines: Qualification Strategies and Challenges from a National Control Lab Perspective

Apr 27, 2020 11:15am ‐ Apr 27, 2020 11:40am

Identification: M104

Experience shows that the handling of compendial and especially non-compendial and in-house reference standards and materials are often a challenge for OMCLs (Official Medicines Control Labs). The qualification of biological reference materials by the manufacturer and the OMCL has a direct influence on the final results of analytical tests and is thus of extremely high importance. The replacement of the reference vaccine’ case study highlights the difficulties encountered by the manufacturers and National Control Labs dealing with biological materials and methods(e.g. :In vivo, ELISA), and how to overcome them.

A Curve Similarity Index for Testing Parallelism in Bioassay

Apr 27, 2020 11:40am ‐ Apr 27, 2020 12:05pm

Identification: M105

Potency determination via bioassay is a relative measure that requires an evaluation of parallelism between the dose-response relationships of a reference standard and sample material. Typical approaches for assessing parallelism include difference (p-value) and equivalence tests. These traditional methods rely on a statistical assessment of model parameters as opposed to direct evaluation of the similarity of the dose response curves. A simple and intuitive curve similarity approach is proposed that tests the hypothesis that the sample material is a dilution or concentration of the reference standard. The test is achieved by quantifying the total area between the two curves and provides a single composite measure of parallelism that ranges from 0 to 1. Both a frequentist and a Bayesian approach to the test are provided. A simulation study shows that the curve similarity approach overcomes the drawbacks of the typical methods and is effective at detecting parallelism and non-parallelism for bioassays.

Vendor Showcase - Catalent, Inc.

Apr 27, 2020 12:05pm ‐ Apr 27, 2020 12:15pm

Identification: M106

Catalent Biologics provides advanced technologies and solutions for protein and gene therapy development, manufacturing and clinical supply. With technology platforms including GPEx® cell line engineering, SMARTag® bioconjugation and AAV viral vector expression combined with comprehensive analytical services and fill/finish supply, Catalent Biologics is your premier partner for clinical and commercial success.

Panel Discussion

Apr 27, 2020 12:30pm ‐ Apr 27, 2020 1:30pm

Identification: M107