Therapeutic Antibodies & Biosimilars
- SPS® protect proteins from aggregation and degradation
- LEUKOCARE’s SPS® technologies stabilize and protect the molecular integrity and functionality of therapeutic antibodies
LEUKOCARE’s SPS® technology platform and expertise speed up your development process and product launch
Based on a large number of formulation development projects during the last 10 years, Leukocare has gained broad experience in the formulation of therapeutic antibodies and biosimilars.
As an example and non-confidential showcase, commercially available trastuzumab was dialyzed and formulated in SPS® and control buffer. Melting temperatures of trastuzumab in both liquid formulations were compared by Differential Scanning Fluorimetry (DSF).
SPS®-formulated trastuzumab demonstrated significantly increased melting temperatures compared to the control buffer, indicating a strong stabilizing effect by SPS®.
The original trastuzumab and the SPS® based formulation were also compared during accelerated aging. After storage at 45°C for 28 days, Size Exclusion Chromatography (SEC) demonstrated significant increase in high molecular aggregates for the original formulation. In comparison, the SPS® formulation preserved the monomeric state of the antibody trastuzumab.
Commercially available trastuzumab was dialyzed and then rebuffered with PBS as negative control, with SPS® and compared with the original formulation. The three different formulations were γ-irradiated in lyophilized form with 25 kGy or 40 kGy. Here, irradiation served as a controlled physical stressor.
After γ-irradiation, Size Exclusion Chromatography (SEC) demonstrated significant aggregation of the antibody for both the PBS and the original formulation (decrease in monomer content and increase in high molecular aggregates).
In comparison, the SPS® formulation almost completely prevented irradiation-dependent aggregation as demonstrated by a maintained monomer content still above 98% even after 40 kGy γ‑irradiation.
Hence, SPS® protect therapeutic antibodies during physical stresses, enable terminal sterilization and open new fields of application.