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Quality From the Start: Preparing for a Successful Transition From Late Stage Discovery to the Clinic

OR, United States

Abdelaziz Toumi, PhD; Senior Director, Head of Commercial Solutions Ibex™ Design & Develop Noel Smith, PhD; Head of Immunology, Applied Protein Services Advancing an innovative drug from late stage discovery into the clinic is the most-critical step in drug product development. While drug developers would like to gain as much information on the product as […]

Free

Biologics Drug Product Development: Challenges at the Interface of Formulation, Primary Packaging and Application

OR, United States

As we see pipelines moving to progressively complex biologics—for example, antibody drug conjugates, bispecific antibodies, fusion proteins and other antibody derivatives—the question of a well designed drug product becomes even more pertinent. Within the drug product field, pre-filled syringes and other combination products have been receiving increasing attention as the container closure system of choice […]

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De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools

OR, United States

Rebecca Michael, PhD; Senior Group Leader, Cell and Molecular Biology Group There is a high attrition rate during the development of biotherapeutics impacting the high cost of development. Early identification of the preferred expression host for manufacturing, along with lead candidate screening and material supply can help to reduce both attrition rates and cost. Due […]

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