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In-use physicochemical and microbiological stability of biological parenteral products

2015; Oxford University Press; Volume: 72; Issue: 5 Linguagem: Inglês

10.2146/ajhp140098

1535-2900

Margaret Speed Ricci, Michelle Frazier, Jamie Moore, Mary Cromwell, William J. Galush, Ankitkumar Patel, Michael Adler, Ulrike Altenburger, Ulla Grauschopf, Pierre Goldbach, J Fast, Irene Krämer, Hanns‐Christian Mahler,

Protein purification and stability

Pharmaceutical scientists in the biotechnology industry have traditionally focused on achieving acceptable shelf lives of drug products in their original, unopened product unit configuration (e.g., two years stored at 2–8 °C). However, it is now clear that stability considerations extend beyond