Published: March 15, 2020
Source: Corporate News Center
Amid the global COVID-19 outbreak, UTop Pharma mobilized its scientific and production capabilities to launch an emergency program for the development of core peptide materials used in SARS-CoV-2 diagnostic kits. Within three weeks from project initiation to the first qualified lots, our R&D team overcame key challenges in high-yield expression and high-purity purification of diagnostic peptide segments, enabling fast delivery to downstream IVD manufacturers and demonstrating the company’s technical commitment and social responsibility in a public health emergency.
In February 2020, as testing demand surged and reagent shortages emerged worldwide, UTop Pharma’s R&D center immediately formed a dedicated COVID-19 Response Team. Working around the clock, the team screened candidate peptide sequences by aligning and analyzing spike (S) and nucleocapsid (N) protein regions, prioritizing linear peptides with the highest predicted immunoreactivity.
To meet the urgent need for high-throughput synthesis, we deployed multiple parallel automated solid-phase peptide synthesizers and completed lab-scale verification and purification protocol design for core peptide targets within 72 hours.
“Time literally means lives — our goal was to get high-quality materials into testing pipelines as fast as possible.”
— Head of R&D, UTop Pharma
Diagnostic peptide segments for SARS-CoV-2 tend to be relatively large and structurally complex, making them vulnerable to degradation or activity loss during purification and lyophilization. UTop Pharma’s scientists addressed these issues by optimizing protecting-group strategies, refining pH gradients in the synthesis workflow, and applying a proprietary low-temperature lyoprotectant formulation.
The combined improvements produced materials with >99.3% purity and >96% retention of biological activity after processing. In parallel, we established a rapid testing and validation pipeline capable of completing potency, antigen-binding, and lyophilization stability assessments within 24 hours, significantly accelerating batch release and quality assurance.
Multiple IVD manufacturers validated the materials and incorporated them into their assay formulations as critical components.
The project was executed through tight collaboration across the company:
R&D drove sequence selection, process development and sample validation;
Manufacturing scaled the process to pilot production while maintaining robust quality metrics;
Supply chain coordinated logistics and customs, enabling deliveries to partners despite international transport constraints.
By the end of March 2020, UTop Pharma had supplied core peptide materials to 18 IVD companies worldwide, including partners in Europe, South Korea and Southeast Asia.
“As a supplier of biological raw materials, our scientific capability carries a responsibility beyond commerce.”
— CEO, UTop Pharma
The COVID-19 core peptide project not only demonstrated UTop Pharma’s capacity for rapid technical mobilization but also reinforced our role in the global health ecosystem. By applying our peptide expertise to an urgent public need, we progressed from a technology innovator to an active contributor in pandemic response.
Looking forward, UTop Pharma will continue to develop a long-term Public Health Raw Material Strategy, maintain an emergency reserve of critical materials and capabilities, and promote the application of high-quality biological raw materials in global health protection.
Issued by: R&D Center
Editor: Corporate Branding Department
Date of Publication: March 15, 2020
