Stabilization of a hydrophobic recombinant cytokine by human serum albumin

Aggregated Recombinant Human Interferon Beta Induces Antibodies but No Memory in Immune-Tolerant Transgenic Mice

“…described the use of a TSKgel SW2000 HP-SEC column with a mobile phase of 100 mM sodium phosphate and 200 mM NaCl at pH 7.2 to analyze rhIFNβ-1a and rhIFNβ-1b products with large amounts of human serum albumin (HSA) (7). HSA is commonly used in formulations to prevent adsorption of hydrophobic protein products (7,33,34). The absence of HSA in our rhIFNβ-1a formulations may explain the low protein recovery of our samples in this HP-SEC procedure, i.e.…”

Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality

“…8 In a formulation study of a therapeutic cytokine formulated with human serum albumin, more than 90% of subvisible particles were in the 1–2 μm size range, 7–9% were 2–10 μm and less 0.01% were larger than 10 μm. 15 Similarly, subvisible particle counts in a recombinant hemoglobin product documented that particles smaller than 10 μm were approximately two orders of magnitude greater in number than particles larger than 10 μm. 16 As demonstrated by these examples, protein products that contain extremely large numbers of particles smaller than 10 μm might meet the current USP requirement for subvisible particles.…”

“…8,15,16 For example, during filling pump operations, it was found that an IgG formed hundreds of thousand of particles per ml in the 1.5–3 μm size range, but less than 1000 particles per ml in the 8–15 μm size range. 8 In a formulation study of a therapeutic cytokine formulated with human serum albumin, more than 90% of subvisible particles were in the 1–2 μm size range, 7–9% were 2–10 μm and less 0.01% were larger than 10 μm.…”

The Use of Flow Cytometry for the Detection of Subvisible Particles in Therapeutic Protein Formulations

“…10 Samples of therapeutic cytokine formulated with human serum albumin, with 40,000 total particles, had 90% of population in the 1-2mm size range, as determined by averaging a number of light obscuration measurements using a PAMAS system (Bad Salzflen, Germany). 25 Both sensitivity and throughput of FC approach brings a promise of improving the practically achievable detection limit. These light-based particle detection techniques have unrealized potential for improved resolution.…”