gChem Launches PROCIPIENT® Sterile

gChem Launches PROCIPIENT® Sterile, Extending the Industry’s Trusted Standard for Pharmaceutical-Grade DMSO
Building on the purity of PROCIPIENT®, delivering sterility, traceability, compliance, and confidence for advanced biologic applications.

gChem today announced the commercial launch of PROCIPIENT® Sterile, a manufacturer-produced sterile DMSO solution developed to meet the increasing demands of biologics, cell and gene therapy, cryopreservation, parenteral formulations, and other advanced pharmaceutical applications.

For decades, PROCIPIENT® has served as a trusted pharmaceutical-grade DMSO platform recognized for exceptional purity, regulatory compliance, and product consistency. PROCIPIENT® Sterile builds upon that legacy by combining the trusted quality of the PROCIPIENT® brand with sterile processing, enhanced traceability, comprehensive documentation, and the technical support required by today’s most advanced therapies.

As biologics become increasingly sensitive to their formulation environment, developers are placing greater emphasis on controlling every aspect of the manufacturing process, including excipients. Once considered passive components, excipients have evolved into functional elements of formulation design. They are now critical process inputs that can influence product consistency, process reproducibility, and confidence in manufacturing outcomes.

Designed for Advanced Therapeutic Applications

PROCIPIENT® Sterile is manufactured to support organizations seeking greater control, accountability, and regulatory readiness throughout development and commercialization.

Key product attributes include:

99.99% purity
Alignment with USP/NF and European Pharmacopoeia standards
USP sterility testing, including endotoxin, bioburden, and particulate assessments
Quality documentation and regulatory support
Enhanced supply chain transparency and traceability
Available in convenient 50 mL sterile vial presentations

Regulatory expectations surrounding raw material quality, documentation, and traceability continue to evolve. PROCIPIENT® Sterile was developed to help manufacturers address these challenges by providing a sterile DMSO solution supported by robust quality systems, controlled manufacturing processes, and detailed technical documentation.

By building directly upon the PROCIPIENT® platform, customers gain access not only to a high-purity excipient but also to the documentation, safety information, and technical expertise required to support quality-by-design initiatives, process validation activities, technology transfers, and regulatory submissions.

PROCIPIENT® Sterile reinforces gChem’s commitment to delivering safer, compliant, and high-performance solutions that help customers reduce risk, improve consistency, and accelerate innovation.

To learn more about PROCIPIENT® Sterile visit: PROCIPIENT® Sterile