Bioassays and Bioanalytics - Online Training Recording
Course No. 19184A
Objectives
The Live Online Training includes a general discussion of GMP, GLP and GCLP principles and how they apply to potency assays, limits tests, pharmacokinetics, pharmacodynamics and immunogenicity. Furthermore you will learn the principles of phase specific validation as they relate to potency Bioassays and limits tests. We will outline the industry guidelines on PK assays with an emphasis on the accuracy and precision expectations for biopharmaceuticals, including Incurred Sample Reanalysis. The immunogenicity section helps the participants understand important regulatory expectations by a systematic evaluation of critical portions of the EMA guidance. In addition you become acquainted with the specific challenges of transferring Bioassays between laboratories and you get a checklist to identify and overcome the hurdles in the process. Workshops on writing validation protocols provide hands-on experience to cover these pivotal documents. You will also hear case studies that add relevance to the lecture materials and provide a launch point for class discussion.
Background
The number of biopharmaceutical products is increasing in the clinic and in the market. Their excellent targeting ability is the result of a high complexity that cannot be measured by analytical tests alone. Therefore, the development process of all biopharmaceutical products requires non-analytical tests to fully evaluate their functionality and safety. Biopharmaceutical development is a multi-disciplinary effort that involves many professionals with diverse backgrounds. This course will help team members without the appropriate technical background by clarifying the timelines, requirements and significance of Bioassays based testing. The types of methods that will be addressed are cell-based assays, immunoassays and molecular assays.
Target Group
Manufacturing process professionals
QA/QC staff and regulatory personnel
Clinical staff, pharmacologists and toxicologists
Project managers & outsourcing personnel
Analytical chemists and biochemists
Technical Details:
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
Introduction to Bioassays and Bioanalytical Methods
What is a potency assay?
Product analytics versus Bioanalytics (preclinical & clinical approach)
Why do we need bioassays?
Characterisation of Biopharmaceuticals & Biosimilars
Regulatory Expectations and Requirements on Bioassays and Bioanalytical Methods
Introduction and general aspects
Bioassays and methods – expected data
Guidance documents
GMP & G(C)(L)P Guidelines (EMA & FDA)
Overview and Interpretation
Development of Bioactivity / Potency Assays – selecting Methods and Types of Assays
Assay Types
Feasibility
Preparing the Cell Bank
Optimization Parameters
Replacement methods for primary assays
Readouts
Development of Immunoassays for GCLP Bioanalytics
Standards and controls
Eliminating edge and hook effects
Setting system suitability criteria
Strategies and Techniques to Improve Assays
Improve accuracy and repeatability
Avoid common technical errors
Statistical Analyses & Trending
Development of clinical Assays (PK/PD/ADA)
GMP Validation of Bioactivity (Potency) Assays
Guidelines and Requirements
Validation Parameters
Setting Realistic Sample Specs for Validation
Phase Specific Validation
Validation Report
DOE
DOE versus OFAT
Case Studies on Special Bioassays for Biopharmaceuticals and Biosimilars
ADCC/CDC
RBA mAb
Method Transfer
How to transfer a method?
Transfer tools during product development
Donor and Acceptor
Investigation, calculation and comparison of method Parameters
Recording from 26/27 October 2021
Duration of Recording: approx. 11 h 32 min
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
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