Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products - Live Online Training

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. Case studies 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.

 

The active components in biotechnological/biological products are typically proteins and/or polypeptides. They have distinguishing characteristics to which consideration should be given in any well-defined testing program designed to confirm their stability during the intended storage period. The products are particularly sensitive to environmental factors such as temperature changes, oxidation, light, ionic content, and shear. In order to ensure maintenance of biological activity and to avoid degradation, stringent conditions for their storage are usually necessary.

The evaluation of stability may necessitate complex analytical methodologies. Appropriate physicochemical, biochemical and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products should also be part of the stability program.

In order to get the approval to conduct a clinical trial data have to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Product (IMP). In the new Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials particular provisions are laid down on how to document stability and other quality related data within the CTD structure.