Abstracts (Alphabetical by Speaker/Instructor/Presenter)

How Does an Antibody Drug Conjugate (ADC) Work In Vitro? Development & Validation of Cell-Based Methods to Measure its Cytotoxic Activity and Internalization

• Speaker: Martina Antonelli, Merck KGaA
• Abstract: Antibody-Drug Conjugates (ADCs) are innovative, complex and unique molecules, composed of a monoclonal antibody conjugated to a potent cytotoxic payload via a chemical linker, each of which contribute to the pharmacokinetics, immunogenicity, efficacy and toxicity profile. Due to the relevance of the biological activity as critical quality attribute, Health Authorities require the validation of bioassay mimicking the mechanism of action (MoA). The mechanism of action is based on the ability of the ADC to bind the specific target on the cell surface, initiating the cytotoxic process through the internalization of the complex and the intracellular release of the toxin. Ultimately the effect is selective cancer cell death. This work demonstrates the applicability of cell-based assays to mimic the MoA of the ADC in vitro, developing a specific cytotoxic assay in a human cell line, supported by live imaging that shown the internalization process.
• (Day 2, Interest Group 2: Monoclonal Ab)

AAV: A Holistic Approach to Development

• Speaker: Lisa Blackwood, Sartorius Stedim BioOutsource
• Abstract: Adeno-associated virus (AAV), an emerging therapeutic, comes with more complexities than more traditional therapies such as monoclonal antibodies. Manufacturing even non-therapeutic samples comes with its own issues. We use an orthogonal approach to develop the methods to determine the identity, purity, potency and safety of AAV therapies.
• (Day 2, Interest Group 1: Gene Therapy)

Is (Cell) Banking Enough to Save Your Investment (in Your Potency Assay)?

• Speaker: Paola Cecchini, Lonza
• Abstract: The presentation will highlight the importance of cell bank qualification using flow cytometry to assess a constant expression of receptor expression during cell culture. Cells expressing the relevant target receptor represent the fundamental starting substrates for potency, therefore, the availability of well-characterized cell banks capable of supporting the potency assay testing is imperative to ensure uninterrupted drug product testing and supply to patients. To support the potency assay master cell banks (MCBs) and working cell banks (WCBs) are generated. To prove banks are fit-for-purpose for the potency assay, most of the time cells are tested using the same potency assay they have been generated for. However, the receptor expression assay is the appropriate method to prove the cells are fit-for-purpose and constantly expressing the receptor during the maintenance in culture. Case studies will be presented to illustrate the receptor expression assay as an investment to also 1) prove WCB is comparable with MCB and any subsequent WCB are equivalent, 2) increase the understanding and control over the potency assay, 3) support quality event investigations if assay is underperforming, and 4) Indicate assay robustness.
• (Day 3, Session 3: From Animals to Molecules: Simplifying the Potency Assay Session)

Developing a Network. Supporting SARS-CoV-2 Vaccine Clinical Trials Through the CEPI Centralized Laboratory Network

• Speaker: Sue Charlton, UKHSA
• Abstract: This talk will be about the establishment of the CEPI centralised lab network with a focus on the work done to support COVID vaccine development. It will cover the methods available, the general approach used for transfer and the lessons learnt from this. Finally, a look at how the work of the lab network is developing as we move on from COVID.
• (Day 1, Session 1: Current Trends in Bioassays Session)

Improving Assay Performance through Trending and AI Prediction

• Speaker: Jon Christensen, Novo Nordisk
• Abstract: Potency is a critical quality attribute of biological products. It gives insights into the efficacy of the product, which standard analytical techniques can’t provide. Due to the increased complexity of biological products and the cellular systems used, control and trending of potency assays are becoming ever more important. However, laboratory procedure data and analysis data are often located in disparate systems and thus complicating data aggregation and trending.
  To overcome this barrier, a data pipeline was developed to extract, curate and join the data sources. This new dataset served as the foundation for two paths to improve potency assays:
  1) Develop of an assay prediction tool based using the Random Forest algorithm. The tool can, predict the likelihood of a given sample to pass the assay system suitability tests. Using this tool, we identified critical assay step, and hence an optimal laboratory procedure was established leading to a significant decrease reruns.
  2) Establish of an assay trending dashboard where the influence of critical assay parameters, like cells and instrumentation, on system suitability tests can be visualized and tracked.
• Contributing Authors: Christensen, J. H.¹, Schleicher, S. R.¹, and Amstrup, J.^{1
  1} Novo Nordisk, Maaleov. Denmark
• (Day 1, Session 1: Current Trends in Bioassays Session)

How Much Can We Reduce the Complexity of Bioassays?

• Speaker: Florian Cymer, F. Hoffmann-La Roche
• Abstract: Bioassays used for QC lot release and stability assessment are typically quite expensive per reportable result and are often performed with a standardized setup with a predefined number of points in the dose-response curve (DRC), predefined number of replicates on a plate and a predefined number of plates. This standardization yields benefits when defining processes in QC labs but can be detrimental to sample throughput, costs and overall efficiency.To address this challenge, we created a tool developed in Excel with Visual Basic and macros, which determines the minimum number of concentration points necessary for a reliable DRC based on predefined acceptance criteria from method validation. The tool also examines the usefulness of data replicates on a single plate as well as the usefulness of three plates versus two to generate a reportable result. The case study focuses on three monoclonal antibodies in late stage clinical development and demonstrates the possibility to reduce the resources required per reportable result while still producing reliable and accurate data. Furthermore, it provides recommendations on the minimum number of plates necessary to achieve a reliable level of accuracy in the assays investigated. The tool can be used for any set of validation data and can therefore help to streamline sample throughput, reduce costs of Bioassays and increase overall efficiency.
• Contributing Authors: Florian Cymer and Annie Pham
• (Day 3, Interest Group 3: Data Analysis)

Potency Assay Strategy from Early to Late Clinical Development: A Bispecifics Case Study

• Speaker: Simone De Haij, Genmab
• Abstract: This presentation will be a product specific case study and will discuss the following topics:
  – evolution of potency assay strategy from first in human study to BLA filing
  – develop fit for purpose assay using primary cells
  – comparison bioassay data to primary cell assay
• (Day 3, Interest Group 4: Stage Appropriate Potency Assays)

Potency Assays Using Targeted Mass Spectrometry

• Speaker: Moreno Di Marco, Solvias
• Abstract: A potency assay based on targeted mass spectrometry shall be presented as alternative for ELISA and as readout for cell-based bioassays.
• (Day 3, Session 3: From Animals to Molecules: Simplifying the Potency Assay Session)

Robo meets DoE: Using Fully Automated Design of Experiments Approach (DoE) for Potency Assay Development

• Speaker: Karoline Eppler, Boehringer Ingelheim Pharma GmbH & Co.KG
• Abstract: DoE is a crucial part during the development of potency assays at the Potency Assay Skill Center of Boehringer Ingelheim Pharma. The DoE approach is accelerating assay development by 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 helps to identify interactions of factors which are only hardly detectable with the “one factor at the time” approach (OFAT). However, manual execution of a potency assay DoE is very complex, elaborate and prone to human errors. By using a fully equipped robotic system in combination with a scheduling tool planning and execution is much easier and more efficient. Furthermore, the approach reduces the hands-on time significantly and increases the assay throughput. Thus, the combination of DoE with a fully automated robotic systems provides a major benefit for development of potency assays.
• Contributing Authors: Tanja Gaissmaier, Dr. Katharina Kuenzel, Dr. Caterina Giorno, Dr. Matthias Kania
  Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach (Riss), Germany
• (Day 1, Session 1: Current Trends in Bioassays Session)

Care and Feeding of a Late-Stage Potency Assay

• Leaders: Siân Estdale, Labcorp, Alex Knorre, Eurofins Biopharma Product Testing, and Bassam Hallis, UKHSA
• Abstract: This two-part workshop covers 2 critical topics for the debut of late-stage potency assay into a commercial environment: Method Transfer and the establishment of potency assay product reference material. Specifically, we will discuss:
  Assay Transfer
  ● Assay preparedness for method transfer
  ● Types of method transfer including co-validation, transfer protocol and other approaches
  ● Assay monitoring data and the interim system suitability criteria to ease transfer.
  Reference Material
  ● Selection of Reference Material for BLAs and initial years of product approval
  ● Qualification of Reference Material
  ● Requirements for Monitoring the Reference Material
• Contributing Authors: Siân Estdale¹, Alex Knorre², Bassam Hallis³, and Laureen Little^{4, 5
  1} Labcorp Drub Development; ² Eurofins BioPharma Product Testing; ³ UK Health Security Agency; ⁴ BEBPA; ⁵ Quality Services
• (Day 1, Workshop 2: Care and Feeding of a Late-Stage Potency Assay)

Stage-Appropriate Bioassays for Assessing ADCP Activity of Therapeutic Antibodies

• Speaker: Julia Gilden, Promega Corporation
• Abstract: Antibody-dependent Cellular Phagocytosis (ADCP) is an important mechanism of action (MOA) of therapeutic antibodies designed to deplete diseased cells such as tumor cells. ADCP can be mediated by a variety of effector cell types, including monocytes and macrophages, and is induced via simultaneous binding of antibodies to FcγRIIa, FcγRI, or FcγRIIIa on effector cells and a specific antigen on target cells. Traditionally, flow cytometry assays are used for direct measurement of ADCP, but these methods are laborious and highly variable, relying on the extended ex vivo culture of primary human cells, with the inherent donor-to-donor variation that entails. To address this, we have developed two plate-based bioassays for measuring the ADCP activity of therapeutic antibodies, with utility at different stages in the drug development process.For early phase programs, we have created an ADCP assay based on NanoBiT split luciferase technology. Here, primary macrophages are incubated with engineered HiBiT-expressing target cells. At the end of the incubation period, cells are lysed and HiBiT retained in the target cells is released to complement LgBiT in the detection reagent, producing light in proportion to the number of target cells present. Lysosomal degradation of HiBiT following ADCP results in a robust loss of luminescence in the presence of ADCP-inducing antibody. The assay is highly reproducible and easy to execute with little hands-on time. Target cells and primary macrophages are both supplied in a Thaw and Use format, making the assay simple to execute while maintaining high physiological relevancy.For later phase programs, we have developed an ADCP reporter bioassay in a naturally phagocytic cell background, THP-1, where NanoLuc luciferase reporter activity is driven by signaling through endogenously expressed Fc receptors. This bioassay has been prequalified according to ICH guidelines and is suitable for potency and stability studies in quality-controlled settings.
• (Day 3, Interest Group 4: Stage Appropriate Potency Assays)

Co-implementation and Co-validation of Potency Methods

• Speaker: Matthias Hofmann, Lonza
• Abstract: Even if DS and DP manufacturing sites are often situated at geographically distant locations, both sites need to use the same potency method for DS and DP release purposes.Historically, after successful implementation of a potency method at the DS site, the method is transferred to the DP site. However, laboratory setup of those sites may differ with respect to, for instance, instrumentation and processes. This poses risks to a smooth method transfer, particularly of more complex potency assays, such as cell-based assays.
  In order to avoid such challenges, Lonza introduced the concept of method co-implementation and co-validation. In short, the lead site and the partner site collaborate early on, starting with the feasibility check, extending to set-up assays, and finally to method co-validation. This helps reduce method performance mismatches between sites and enables the efficient creation of robust potency methods early on, reducing the risk of delays.
• (Day 2, Session 2: Validation of Potency Assays Session)

The Matrix Approach for Potency Testing of ATMPs

• Speaker: Sascha Karassek, Charles River Laboratories
• Abstract: Potency testing for advanced therapy medicinal products (ATMPs) is both a guideline requirement and a challenge.Often the mechanism of action (MoA) is very complex and may not be fully understood and the reflection with in vivo fate is difficult to demonstrate.With a matrix approach, various aspects of product characteristics can be assessed. On the one hand, transcriptional, translational, and functional levels can be covered, and, on the other hand, various potential MoAs can be addressed.Brief case studies on bioactivity determination for AAV and lentivirus products, a CAR-T product and a plasmid product using the matrix approach are presented.
• (Day 3, Interest Group 4: Stage Appropriate Potency Assays)

Case Study: Investigation on High Assay Repetition Rate during Otherwise Successful Validation

• Speaker: Marja Kornhuber, Richter-Helm Biologics GmbH
• Abstract: Prior to validation of a cell-based proliferation assay, the assay and sample acceptance criteria were amended and tightened, with the aim to better control the assay. During validation, all validation acceptance criteria were fulfilled, but an extremely high assay repetition rate was observed. Assay and sample failure rates amounted to 29 % and 21 %, respectively. Based on this observation the robustness of the assay in general was called into question. A detailed investigation of the high failure rates was started based on the whole data set, also including the formal robustness study data. During robustness testing, the failure rate was also high but generally lower. The investigation showed that too many and too tight SSTs were set, especially regarding the acceptance criteria for the measures of precision: intra- and inter-assay precision. The validation data were re-assessed with redefined acceptance criteria, and the assay repetition rate could be significantly reduced without affecting the overall validation result itself. Finally, robustness and validity of the assay could be demonstrated by applying suitable SSTs.
• (Day 2, Session 2: Validation of Potency Assays Session)

The Importance of Target Cell Membrane Complement Regulatory Proteins (mCRPs) on CDC Assay Development

• Speaker: Rok Kosir, Novartis Pharmaceutical Manufacturing LLC
• Abstract: Complement dependent cytotoxicity (CDC) plays a vital role in the efficacy of monoclonal antibody (mAb) therapy. The activation of the complement cascade by mAbs leads to the formation of the membrane attack complex, resulting in the lysis of target tumor cells. However, the efficacy of CDC can be downregulated by the overexpression of membrane complement regulatory proteins (mCRPs), such as CD46, CD55 and CD59) on malignant cells. These proteins inhibit activation of the complement cascade, reducing in vivo efficacy of CDC but can also influence the development of in vitro CDC potency assays. In-vitro CDC assays provide important information both for the development of originator and biosimilar mAb as well as for ongoing release and stability testing. We have observed that in addition to the selection or generation of appropriate target cell lines the choice of the complement source also has a critical impact on CDC assay development. To this end we investigated the effect of two common complement sources, target cell type and amount of mCRP proteins on the development of a CDC potency bioassay. We will present our data on the effect and difference between the use of human and rabbit complements on mAb CDC efficiency.
• Contributing Authors: Rok Kosir¹, Aleksandra Uzar¹, and Irena Oven ^{1
  1} Novartis Pharmaceutical Manufacturing LLC, Kolodvorska cesta 27, 1234 Mengeš, Slovenia
• (Day 2, Interest Group 2: Monoclonal Ab)

Using Mixed Models to Reduce Relative Potency Bias From Allowed Non-Similarity

• Speaker: David Lansky, Precision Bioassay Inc.
• Abstract: This course develops a comprehensive approach to bioassay using statistically efficient designs and nonlinear mixed model analyses. In combination, these support narrow similarity equivalence bounds (reducing bias), improve the precision of potency, and yield quantitative monitoring tools.
• (Day 1, Workshop 1: Mixed Models and Similarity)

Discussion of Repeat Analysis Approaches for Invitro Bioassay Analysis and Reporting

• Speaker: Prerna Maheshwari, Lonza
• Abstract: For most biopharmaceuticals, potency is assessed in a bioassay by comparing the dose -response curve of the test material and a reference standard. Bioassay systems are complex and tend to be sensitive to a greater variety of factors that are most physicochemical techniques. Some factors like pipetting controls, temperature, critical incubation time, serial dilutions errors can be controlled, but cell response, cell clumps cannot be controlled. Variation in these factors affects the response of a bioassay system to a test product, so its potency measurement is not an absolute value. Bioassays are therefore comparative, with the biological activity of a test material measured relative to that of a reference preparation. If the reference preparation is very similar to the test product, then their measured biological dose–response relationships should be affected equally by any variation in the system. Relative potency should, therefore, remain constant even though the measured response may vary among assays.When the inherent variability of a biological response, or that of the log potency, precludes a single assay data set’s attaining a value sufficiently accurate and precise to meet an assay specification, the assay may consist of multiple blocks or complete replicates needed depends on the assay’s inherent accuracy and precision and on the intended use of the reported value. It is practical to improve the precision of the reported value by reporting the geometric mean potency from multiple assays.The purpose of this paper is to provide guidance on various approaches to bioassay data analysis and reporting of results.
• (Day 3, Interest Group 3: Data Analysis)

Replacing Animal Testing: A Successful Journey to the Approval of an In Vitro Potency Assay for FSH

• Speaker: Chiara Modena, Merck KgA
• Abstract: Regulatory authorities are nowadays strongly encouraging the replacement of existing animal testing with in vitro ones, opening the door for companies to switch from in-vivo to in-vitro methods.For more than 20 years, Gonadotropin drugs have been routinely tested with in-vivo potency assay to support batch release.For r-hFSH biopotency, the Steelman–Pohley bioassay, measuring ovarian weight increase in immature rats, is currently the only method published in the pharmacopoeias.The switch from the Steelman–Pohley to an in vitro potency assay was attractive for the company first, and most importantly, for ethical reasons, to replace animal use in quality control activity as recommended by the 3R principles; secondly, to potentially reduce assay time and costs, and increase flexibility.For this aim, an in vitro potency assay was developed and validated to determine biopotency by detecting the increase of cAMP, induced by the dose-dependent FSH receptor activation.In addition, an extended structure-activity relationship (SAR) study was performed to evaluate the capability of the two assays to discriminate chemical structural modifications of critical quality attributes. The final goal was to support the submission package of the in vitro test as alternative to the Steelman–Pohley bioassay.The approach proved to be successful and the in house- in vitro potency assay for r-hFSH received the first approvals to replace the in vivo bioassay DS batch release, in July 2022 by Canada and in October 2022 by the European Medicines Agency (EMA). It is now being performed as QC test following the respective country approvals.
• (Day 3, Session 3: From Animals to Molecules: Simplifying the Potency Assay Session)

Validation and Bridging of a Flow Cytometry-Based Potency Assay

• Speaker: Frances Reichert, Eurofins BioPharma Product Testing Munich GmbH
• Abstract: An in vitro cell based flow cytometry potency bioassay for a therapeutic monoclonal antibody had been established and validated according to ICH Q2(R1). The method was proven to be accurate and precise concerning intra-assay as well as inter-assay variability. After successful validation the method had to be transferred to a different flow cytometer from another vendor. Both the validation results and the subsequent instrument bridging data will be presented in this case study.Eurofins BioPharma Product Testing Munich GmbH, Planegg / Munich, Germany
• (Day 2, Session 2: Validation of Potency Assays Session)

In-Depth Investigation of SPR-Based Kinetic Binding Assays for the Antibody-FcRn Interaction

• Speaker: Bas Rosier, Genmab
• Abstract: The neonatal Fc receptor (FcRn) plays a crucial role in the pharmacokinetic profile of therapeutic antibodies by extending in vivo half life through a pH-dependent binding mechanism. We have performed a detailed investigation into the kinetics of antigen-FcRn interactions using surface plasmon resonance (SPR), which allows us to determine the absolute affinity of the interaction as well as association and dissociation constants. We systematically investigated the effect of experimental conditions (including buffer pH and composition) on FcRn binding using a Design-of-Experiments approach, as well as the mitigation of avidity (bivalent) binding by applying several different assay formats and antibody controls. In addition, we propose a general statistical method of establishing (multivariate) comparability windows for kinetic assays (SPR-based or other) that report absolute experimental quantities instead of relative binding or potency values.
• (Day 2, Interest Group 2: Monoclonal Ab)

Turning Cells into Reagents: A Proof-of-Concept Study to Compare Cultured vs Thaw-Use Cells in Cell-Based Potency Assays

• Speaker: Caroline Seiler, Labcorp
• Abstract: Cell-based potency assays are critical to ensure quality, consistency, and stability of biopharmaceutical products. However, a major challenge for potency assay development is the inherent variability of the cell line, the critical reagent in the assay. Cellular behaviour varies with cell age, cell cycle stage and the accumulation of genotypic changes over time, all of which impact how the cell responds to a drug product. Variability in cell behaviour can result in a lack of assay reproducibility and unacceptable assay failure rates. Additionally, continuous culture of cells is time consuming, carries a constant risk of contamination and is expensive due to the specific laboratory infrastructure and waste disposal routes required. Passaging routines can also put constraints on assay scheduling and lead to delays due to the time lag between cell thaw and first use leading to long development times and failure to meet deadlines.Many of these challenges can be overcome by the use of “assay ready cells” that are simply thawed and used immediately or the following day in the assay. In this study we compared the performance of “assay ready cells” to cultured cells in two different cell-based potency methods. For each method, we assessed assay accuracy, linearity, repeatability, and intermediate precision.Method 1 was a cytotoxicity assay where Daratumumab mediated complement dependent cell death was monitored in Daudi cells using Alamar Blue. Assay accuracy was measured at five target potency levels and no statistically significant difference was observed between the potencies measured using cultured cells vs “assay ready cells” (p value 0.35), the difference between geometric mean potencies for each target level was less than 15%. A linear relationship between potencies measured using cultured cells and assay ready cells was observed with an R2 value of 0.97. Equivalent intermediate precision was observed across cultured and assay ready cells with a maximum % GCV of 16 observed with assay ready cells at the 50% target potency.Method 2 was a cell viability assay where inhibition of TNF-α induced apoptosis by Adalimumab was measured in L929 cells using ATP Lite. No statistically significant difference in assay accuracy was observed between the potencies for cultured cells vs “assay ready cells” (p value 0.29) and the difference between geometric mean potencies for each target level was less than 10%. Assay trending showed less variability in the reference standard and quality control performance across assays. A linear relationship between potencies measured using cultured cells and assay ready cells was observed with an R2 value of 0.97. The thaw and use cell format was highly precise with %GCV of 4% for repeatability and intermediate precision ranging between 1 and 7% GCV at the different potency levels.This study successfully showed assay ready can be used in both cytotoxicity and cell viability potency assays. Both thawing cells and immediately using them in the assay vs thawing them the night before the assay were tested. Additionally, two different freezing down methods for cells were used; cool cells and a cell planar, both methods produced viable working cell banks. Relative potencies were not significantly altered using the “assay ready cells” in either method. Not only are the “assay ready cells” more convenient and cost effective, but improved precision was observed in method 2, likely due to the cells being cryopreserved in an identical functional state.
• (Day 3, Session 3: From Animals to Molecules: Simplifying the Potency Assay Session)

Implementation of SARS-CoV-2 Variants of Concern into a Validated Microneutralization Assay for Clinical Testing

• Speaker: Imam Shaik and Alexandra McEntee, UK HSA
• Abstract: UKHSA have developed, qualified, and successfully validated a live virus Microneutralization Assay (MNA) against B.1 Victoria/1/2020 SARS-CoV-2, for use in vaccine clinical trial research. The SARS-CoV-2 MNA measures virus-specific neutralising antibodies in human serum samples. The data generated from the UKHSA MNA, helps inform JCVI and vaccine developers to make decisions on optimising of current vaccines, addressing variants of concern, and developing next-generation COVID-19 vaccines. Since the outbreak in 2019, there has been a continuous emergence of new SARS-CoV-2 variants and some of them are associated with increased infection rates. To allow vaccine developers to assess vaccine candidates’ efficacy against emerging variants, there is a requirement for UKHSA to implement these variants in the MNA. Due to the validated status of the Microneutralisation assay it is necessary for the SARS-CoV-2 variants of concern to be appropriately characterised, optimised and validated for use in the assay. We describe the process of virus banking, optimisation, characterisation, and validation of the variants for use in the assay.
• (Day 2, Session 2: Validation of Potency Assays Session)

Incomplete Dose-Response Curves – A contribution to the discussion on “allowed” non-similarity in biological assays

• Speaker: Ralf Stegmann, Stegmann Systems
• Abstract: Is some non-similarity of dose-response curves acceptable if the calculated relative potency shows no sensitivity to it? What happens if updated equivalence margins for your system and sample suitability criteria are required to reflect this “allowed” non-similarity? In the talk simulation studies are presented which help understanding the impact and risks of the approach.
• (Day 3, Interest Group 3: Data Analysis)

Statistical Perspectives on Potency Assays for Gene Therapies

• Speaker: Matthew Stephenson, Quantics Biostatistics
• Abstract: The complexity of gene therapy products can result in potency assays with high variability, where the coefficient of variation may be as high as 30% to 50%. When designing a potency assay for gene therapy products, it is important to optimize model fit and replication strategies to reduce the variability, if possible. This talk will explore some of the techniques we have implemented and lessons we have learned through consulting on gene therapy potency assays.
• (Day 2, Interest Group 1: Gene Therapy)

USP General Chapter <1033> Biological Assay Validation Update

• Speaker: Ann Yellowlees, Quantics Biostatistics
• Abstract: USP NF General Chapter <1033>: Biological Assay Validation has been available to industry and regulators since 2013. With its worked example it provides the tools for practitioners to conduct a validation study with confidence. The chapter has now been reviewed and updated. The main aims of the update were to provide clarification, and to add detail on some concepts, including choice of acceptance criteria, total error (as an approach to combining accuracy and precision), assay format and assessment of linearity.The commenting period closed on 31 January 2023 and the comments are being reviewed with a view to finalisation after updates and reviews of the other USP bioassay chapters.This talk will focus on the changes to the guidance and their potential benefits for bioassay validation in practice.
• (Day 1, Session 1: Current Trends in Bioassays Session)