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Food and Drug Administration has provided regulatory guidance in the publication Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing available at: which is incorporated herein by reference in its entirety

Cells were lysed with 500 L of RIPA lysis buffer containing 150 mM NaCl, 1% NP-40, 0.5% sodium deoxycholate, 0.1% SDS, 25 mM Tris-HCl, supplemented with protease and phosphatase inhibitors at a 1:100 dilution

Reconstitution B: 10 mg vial + 3 mL BAC water (3.33 mg/mL) more BAC water for larger, easier-to-measure draws