Qprotyn achieves viscosity of 18cP for 250mg/mL of Trastuzumab using its HILOPRO® technology.
Updated: Aug 10
Upgrading Trastuzumab from IV to Subcutaneous (SubQ) administration may now be possible without expensive, high-volume hyaluronidase injections.
With HILOPRO technology
Without viscosity-reducing excipients
Due to patients’ convenience of at-home administration and reduced number of hospital visits as well as the reduction in treatment costs, SubQ administration of biologics is of increasing interest.
Trastuzumab targets Human IgG1/TNFα and is approved for breast cancer, gastric cancer, stomach and breast neoplasms across various geographies. A popular subcutaneous choice in the market uses recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α, trehalose dihydrate, L-methionine, PS20 with an increase in concentration from 21mg/mL in the IV form, to 30mg/mL in the subcutaneous form. [i]
Herceptin Hylecta or Herceptin SC is available for subcutaneous dosage of 600mg over 5mL. To put it in perspective: While it aims to reduce all the hassles of IV administration, it still does not provide all the benefits that should accompany a SubQ upgrade. The patient still has to visit a center, the administration still has to be done by a healthcare professional and the needle still has to be inserted over 5 minutes under the skin of the patient. Also, while hyaluronidase does not show any significant unwanted side-effects, there is a marked increase in anti-hyaluronidase antibodies post administration. [ii] This significantly reduces the degree of patient convenience and the ability to self-administer Trastuzumab.
Qprotyn’s HILOPRO technology for viscosity-reduction provides a concentration of 250mg/mL at 18 cP viscosity that can be easily administered using a 27G needle using one prefilled syringe of 2.4mL – halving the administration volume and time and avoiding the need for hyaluronidase under the skin of the patient.
The Trastuzumab HILOPRO (High-concentration, low-viscosity, low-volume) formulation has shown non-inferiority in animal trials and comparative stability to the innovator at 4C and 25C over 90 days. Additional test results are available on request.
This presents a great opportunity for Trastuzumab biosimilar manufacturers to leapfrog to SubQ using Qprotyn’s safe and simple platform technology that demonstrates dramtic reduction in viscosity using only 2 GRAS excipients.
Qprotyn is ready to provide a proof of concept using HILOPRO technology to check the viscosity reduction feasibility of your mAb within 8 weeks.
Contact us on BD@qprotyn.com for more details.
List of Trastuzumab Biosimilars in-market and in-approvals:
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Qprotyn is a Delaware biotech corporation that is bringing to market a patented viscosity-reduction, formulation platform called HILOPRO.
HILOPRO enables high-dose, large molecule monoclonal antibodies to move from IV administration to subcutaneous (SubQ) injection.
Using only two GRAS excipients, HILOPRO delivers low-volume formulations with concentrations greater than 225mg/mL while maintaining a viscosity less than 20 cP.
Naturally, this introduces tremendous patient benefits in terms of comfort and convenience and enables innovator and biosimilar mAbs to enhance their marketability.
[i] Bittner, Richter, and Schmidt, “Subcutaneous Administration of Biotherapeutics.” [ii] Rosengren et al., “Clinical Immunogenicity of RHuPH20, a Hyaluronidase Enabling Subcutaneous Drug Administration.”