Comparative study of therapeutic antibody candidates derived from mini‐pool and clonal cell lines

The long journey of developing a drug from initial discovery target identification to regulatory approval often leaves many patients with missed window of opportunities. Both regulatory agencies and biopharmaceutical industry continue to develop creative approaches to shorten the time of new drug de...

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Veröffentlicht in:	Biotechnology progress 2017-11, Vol.33 (6), p.1456-1462
Hauptverfasser:	Fan, Lianchun, Rizzi, Giovanni, Bierilo, Kathleen, Tian, Jun, Yee, Joon Chong, Russell, Reb, Das, Tapan K
Format:	Artikel
Sprache:	eng
Schlagworte:	Biopharmaceuticals Biotechnology Cell culture Cell lines CHO cell clonal‐derived cell line Comparative studies Drug delivery systems Drug development Feasibility studies GS knockout Immunoglobulin G Industrial development mini‐pool Monoclonal antibodies Patients Productivity Quality management Regulatory agencies Regulatory approval sequence variant Target recognition therapeutic monoclonal antibody Toxicology
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