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The purpose of the CMC Strategy Forum Europe 2020 is to offer a blend of topics that characterize the challenges facing the biotechnology industry in the next decade…
Antibody drug conjugates unite the specificity and long circulation time of an antibody with the toxicity of a chemical cytostatic drug using smart linkers to reduce systemic toxicity and increase therapeutic index. This combination of a large biological molecule and a small synthetic molecule creates an inherent increase in complexity. Multiple production processes are required to produce the naked antibody, the drug and the linker, followed by conjugation of aforementioned entities to form the final antibody drug conjugate. The connected processes further increase the number of points of control, resulting in necessity of additional specifications and an increased load of analytical characterization. By combining scientific understanding of the production processes with risk-based approaches, quality should be demonstrated at those points where control is required and redundant comparability studies, specifications or product characterization avoided. Over the product development lifecycle, this will allow process qualification to focus on those areas affected by a change and prevent redundant studies. The structure of a module 3 global technical dossier for an ADC needs to reflect each of the production processes and the combined overall approach to quality. Historically, regulatory authorities have provided varied expectations on its structure. An overview is provided of essential information to be included showing that multiple approaches work as long as adequate cross-referencing is included. This talk outlines the content of a white paper soon to be published by a workstream under the Biomanufacturing Working Group by EFPIA.
KBI Biopharma is a leading contract development and manufacturing organization for the biopharmaceutical industry. We accelerate and optimize drug development and manufacturing programs for our client partners…
The EFPIA MQEG Biomanufacturing sub-team has published a number of position papers and is currently progressing industry consensus activities on other key topics…