Method for Detection of Aggregates of Biotherapeutic Substances in a Sample

Simple SummaryContent extracted from patent full text and abstract with AI.

This patent describes a highly sensitive method for detecting and quantifying aggregates (clusters) of biotherapeutic substances, such as proteins or antibodies, in a sample. The process involves applying the sample to a substrate, adding specially labeled probes that specifically bind to the aggregates, and detecting these labeled aggregates using advanced microscopic or optical techniques. The patent also covers a kit designed to carry out the described method.

Use CasesContent extracted from patent full text and abstract with AI.

• Quality control during the manufacturing of biopharmaceutical drugs (proteins, antibodies, etc.)
• Detection of unwanted aggregates in final biotherapeutic products prior to patient administration
• Monitoring stability and shelf life of therapeutic protein formulations
• Clinical studies and therapy monitoring to ensure safety of biological drugs in patient samples
• Early-stage development and formulation optimization in biotech and pharmaceutical research

BenefitsContent extracted from patent full text and abstract with AI.

• Enables highly sensitive and specific detection of aggregates, including very small ones, that are difficult to detect with existing methods
• Improves safety by helping identify aggregates that could cause immune reactions or reduce drug effectiveness
• Allows both qualitative (composition/type) and quantitative (amount, size) analysis of aggregates
• Reduces risk of product recalls and regulatory issues by ensuring better product quality control
• Compatible with high-throughput and automation, which supports large-scale or routine applications in the industry

Technical Classifications (CPCs)

Inventors & Applicants

Patent Abstract

The invention relates to a method for detecting aggregates of biotherapeutic substances in a sample, said method involving the following steps: a) applying the sample to be examined to a substrate; b) adding probes which are labeled for the detection and which mark the aggregates of biotherapeutic substances by specifically binding thereto; and c) detecting the labeled aggregates of the biotherapeutic substances wherein step a) can be carried out prior to step b). A kit for carrying out said method is also disclosed.