Every course listed below is available for on-site or teleconference based training in your company. We can tailor the training according to your specific needs. If you would like to set-up a training or have questions, please reach us at mylene.talabardon@biotechnologyconsultant.com
(ENTRY LEVEL)
This training introduces participants to quality by design (QbD) concept, process validation and CMC regulatory requirements, and provides as well keys to successfully drive your product to market authorization.
(ADVANCED LEVEL)
The training provides a deep understanding on how process validation for biotechnological processes would be appropriately designed and executed to establish scientific evidence that a manufacturing process is capable of consistently delivering quality product.
The training addresses the qualification of the cell bank system, which comprises identity testing, phenotypic & genotypic characterization, and safety testing. It also addresses potential issues encountered when establishing cell banks and discusses operational aspects for ensuring good quality cell banks.
The training gives an overview of the sources and impacts of viral contaminations of biotherapeutics, how to prevent those risks and how to evaluate the capability of the process to remove and/or inactivate potential viruses through viral clearance studies.
The training focuses on ICH M4Q, providing guidance on the format and content of a registration application for drug substances and their corresponding drug products, as defined in the scope of the ICH Guidelines Q6B for biotechnological products.
The training delineates potential adaptations to the traditional approach to product development, product characterization, specification setting, process validation, stability setting, manufacturing and timepoint for full completion of certain quality data packages.
The training addresses the new technologies in cell separation and automatization of chromatography-based processes, showing that continuous manufacturing becomes a valid option for improving manufacturing productivity, flexibility and COGS.
The training addresses the understanding of quality attributes, the purpose of assessing their criticality and how to select critical quality attributes. It is illustrated by a review of physico-chemical variants, process- and product-related impurities and their impact on the product efficacy and safety.
The potency is a mandatory critical quality attribute that manufacturers must evaluate to ensure it conforms to specifications for releasing drug substance and drug product batches. This training addresses common bioassay formats, as well as the development and validation of bioassays to evaluate the potency.