Subcutaneous Anti-PD-1 Formulation With Enzyme-Mediated Absorption
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Solution Overview
Problem
Current methods of delivering anti-PD-1 and/or anti-PD-L1 antibodies for cancer treatment are inconvenient and invasive, necessitating improvements for subcutaneous administration to enhance patient compliance.
Innovation Solution
A pharmaceutical composition comprising an antibody that binds PD-1 or PD-L1 and an endoglycosidase hydrolase enzyme is administered subcutaneously in various dosing schedules and volumes, potentially with a wearable device, to treat tumors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If intravenous administration is used to deliver anti-PD-1 and/or anti-PD-L1 antibodies, then treatment efficacy is maintained, but patient convenience and compliance deteriorate due to invasiveness and clinic/hospital requirement
Solution Approach 1:
The patent changes the physical parameters of the antibody formulation by adding specific excipients (sucrose at 250 mM, polysorbate 80 at 0.05% w/v, and endoglycosidase hydrolase enzyme at 2000 U/mL) to enable subcutaneous administration. This parameter modification allows the formulation to be delivered via less invasive subcutaneous route while maintaining therapeutic efficacy, directly resolving the contradiction between patient convenience and treatment reliability
2Ease of operation
If subcutaneous delivery is implemented to improve patient compliance, then convenience improves, but formulation suitability and delivery reliability worsen without proper formulation optimization
Solution Approach 1:
The patent creates a composite pharmaceutical formulation by combining anti-PD-1 or anti-PD-L1 antibodies with multiple excipients including sucrose, polysorbate 80, and endoglycosidase hydrolase enzyme. This composite material approach ensures the formulation is suitable for subcutaneous delivery by providing necessary stability, solubility, and bioavailability, thereby resolving the contradiction between ease of administration and formulation reliability
Solution Approach 2:
The endoglycosidase hydrolase enzyme acts as an intermediary component in the formulation, facilitating proper antibody processing and stability in the subcutaneous tissue environment. This intermediary substance enables reliable subcutaneous delivery by mediating between the antibody drug and the biological environment, resolving the formulation suitability issue
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The method provides a more convenient and patient-friendly approach to cancer treatment by enabling subcutaneous delivery of anti-PD-1 or anti-PD-L1 antibodies, potentially improving treatment compliance and efficacy.
Implementation Method 1
an endoglycosidase hydrolase enzyme
Data Source
AI summary
The disclosure provides pharmaceutical compositions comprising an anti-PD-1 antibody or an anti-PD-L1 antibody. In some aspects, the pharmaceutical compositions are formulated for subcutaneous delivery. In some aspects, the pharmaceutical compositions further comprise an endoglycosidase hydrolase enzyme. Other aspects of the present disclosure are directed to methods of subcutaneously delivering a pharmaceutical composition comprising an anti-PD-1 antibody or an anti-PD-LI antibody.