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Antibody-Drug conjugate Manufacturing Techniques (La Vague 49)

Monoclonal Antibodies (mAbs) with selectivity towards antigens located on the surface of cancer cells have been successfully developed. Nonetheless, mAbs alone are generally not potent to kill the cancer cells and are therefore used in combination with classical chemotherapies.

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Robust and Convenient Single-use Processing (La Vague 49)

The implementation of single-use addresses the main challenges of the biopharmaceutical industry, e.g. fast and straightforward capacity adaptation, cost savings, risk mitigation as no cleaning is required. Because single-use bags offer multiple technical and economic benefits (1) they are broadly adopted by the entire biopharmaceutical industry to achieve rapid and flexible development and commercial production of monoclonal antibodies, recombinant proteins and vaccines.

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Mass spectrometry as a powerful tool for the characterisation of monoclonal antibodies in the context of comparability studies (La Vague 49)

Due to their mode of production, monoclonal antibodies are complex and heterogeneous molecules.
When changes 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 Q5E guidance[1]. These studies usually require the use of many orthogonal analytical techniques in order to fully characterise the different variants.

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Cahier Pratique - Quality by design applied to viral safety of Biologicals: Case studies & workshop discussion summary (La Vague 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 of processes while providing a design space where variations can be acceptable. While numerous QbD studies have been initiated to assess the process performances, limited publications are available on QbD application to viral safety. In this article we use examples of virus filtration and chromatography to discuss how knowledge base and industry experience can help design a risk assessment and a QbD approach for virus removal steps in a biological process.

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Chromatographie Continue : Solution d’amélioration des performances de procédés et "debottlenecking" des capacités de Bioproduction (La Vague 49)

La Bioproduction d’actifs pharmaceutiques nécessite l’emploi de procédés permettant d’assurer leur qualité et leur sécurité ainsi que d’en maîtriser les coûts de fabrication. L’augmentation de la demande et l’apparition des biosimilaires mettent une pression supplémentaire sur ces coûts. L’accroissement de l’échelle de production peut être atteint sans augmentation significative des coûts spécifiques. En effet, l’ingénierie des lignées cellulaires, l’optimisation de la composition des milieux de culture et le développement de nouvelles méthodes de culture en bioréacteur (i.e. culture à haute densité en continu) ont permis d’augmenter la productivité spécifique.

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