Monoclonal Antibodies (mAbs) with selectivity Towards antigens Located on the area of cancer cells-have-been successfully Developed. Nonetheless, mAbs alone are not Generally potent to kill the cancer cells and are used in combination with The Therefore classical chemotherapies.
The implementation of single-use hand addresses the challenges of the biopharmaceutical industry, eg fast and straightforward adaptation capacity, cost savings, risk mitigation have no cleaning is required. Because single-use bags offer multiple technical and economic benefits (1) They Are Broadly adopté by the Entire biopharmaceutical industry to accomplish achieve rapid and flexible development and business generation of monoclonal antibodies, recombinant proteins and vaccines.
Mass spectrometry as a Powerful tool for the characterization of monoclonal antibodies in the context of comparability studies (La Vague 49)
Due to Their Mode of Production, monoclonal antibodies are heterogeneous and complex molecules.
When exchange rates are made to the manufacturing process of a therapeutic monoclonal antibody, an extensive comparability study Has to be Performed to comply-with the requirements of ICH guidance Q5E . These studies usually require the use of Many orthogonal analytical technologies in order to fully characterise the different variants.
Notebook Practice - Quality by Design Applied to viral safety of Biologicals: Case studies & workshop discussions summary (The Wave 49)
Applying Quality by Design (QbD) to Viral Safety of Biologicals HAS started to be discussed and Implemented to evaluate-the robustness of the viral clearance processes while providing good of a design space Where changes can be acceptable. While QbD Numerous studies-have-been for Assessment Initiated to the process performance, limited publications are available on QbD applied to viral safety. In this article we use examples of virus filtration and chromatography to how the Chat knowledge base and industry experience can help design a risk assessment and a QbD approach for virus removal steps in a biological process.
Continuous Chromatography: The solution for improved process performance and de-bottlenecking of bio-production capacities (La Vague 49)
The bio-production of pharmaceutical active principles requires the use of processes enabling the assurance of their quality and safety together with the control of manufacturing costs. Increased demand and the emergence of bio-similars are adding further pressure on those costs. Production can be scaled up without any significant increase in specific costs. Cell line engineering, optimisation of the composition of the culture media and the development of new culture methods in bioreactors (i.e. continuous high density culture) have enabled an increase in productivity.