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:
* All trademarks, logos and brand names are the property of their respective owners. All company, product and service names used in this website are for identification purposes only. Use of these names, trademarks and brands does not imply endorsement.
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.”