Claremont BioSolutions LLC (CBIO) is an innovative biotechnology company specializing in advanced sample preparation solutions for molecular biology and clinical diagnostics. The company focuses on developing compact, user-friendly technologies that streamline nucleic acid extraction, cell lysis, and protein purification, enhancing the efficiency of research and diagnostic workflows. With a strong emphasis on quality and compliance, CBIO integrates cutting-edge microscale cell disruption and enzymatic technologies within a compact fluidic cartridge to deliver high-performance solutions tailored for diverse applications, including biopharmaceutical research, gene therapy, and microbial contamination testing. The company’s proprietary technologies are designed to improve laboratory efficiency, reduce processing time, and minimize resource consumption while maintaining high accuracy and reliability.

Claremont BioSolutions is in the process of expanding its global market presence through the launch of its RUO SimplePrep® X8 (SPX8) system via international business partners who operate under an ISO-certified quality management system (QMS). As an automated nucleic acid extraction solution for low-copy microbial contamination testing for bioprocessing applications, the modified SPX8 system and cartridge reduce DNA extraction time to one-third of Qiagen’s QIAamp® UCP kit while delivering improved qPCR results. An initial launch strategy is in place, and the company seeks to align its manufacturing and quality management processes with international standards to ensure compliance with the quality requirements of its partners. To facilitate this expansion, CBIO aims to develop ISO-compliant QMS documentation that enhances operational efficiency, strengthens regulatory compliance, and solidifies its reputation as a trusted provider in the nucleic acid testing and microbial contamination detection markets.

The Claremont BioSolutions TMP team was tasked with developing critical QMS documentation to support the international expansion of the SPX8 system. The team drafted a Quality Agreement to formalize expectations with international partners, ensuring alignment in manufacturing and quality standards. A Feature Description Document was created to define key product attributes for marketing and regulatory submissions. Additionally, a Verification and Validation Overview was compiled to consolidate existing testing documentation, streamlining compliance efforts. Lastly, to safeguard intellectual property and facilitate the ordering process, Product Specification documents were developed, and Assembly Instructions for the SPX8 system were produced to ensure consistency in manufacturing and product quality.