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Case Study

The Project Situation

A top pharmaceutical company with a growing portfolio of monoclonal antibodies and other biopharmaceuticals was faced with new challenges in pharmaceutical analysis. The traditional approach of using neat materials as reference materials was no longer the best alternative due to their instability, as many biomolecules are hygroscopic, air sensitive, highly potent, and difficult to isolate without degradation. Although lyophilization is an option and the materials are generally stable, the process can be quite costly and the variability in vial-to-vial materials content presents a higher failure rate which is an issue with high value biologics.

Our Operational Support

Through our Cerilliant brand, we offered an alternative format - a solution-based reference standard that mitigates the handling issues associated with these materials and promotes consistency in analysis. The ampouled format, called Snap-N-Shoot®, protects from air, maintains concentration, and can promote stability.

The Customized Solution

The pharmaceutical company saw significant benefits of conversion to Snap-N-Shoot® standards for use in pharmaceutical assays, including the elimination of weighing and dilution errors, time spent investigating Out of Trend (OOT) or Out of Specifications (OOS) results, efficiency of analytical resources, consistency of assay results across locations, material savings, elimination of safety risks related to handling of hazardous/potent neat materials in the analytical lab and convenience of use.

The development process included solvent studies, production of pilot and commercial batches, development of custom packaging, stability studies, and method transfer activities. Certification was performed using client approved methods. For compounds still in development, the pharmaceutical company is developing analytical methods and planning regulatory filings that specify the use of solution standards.

Results

We were chosen for the development and manufacture of the pharmaceutical company’s private-label compounds because of our expertise and successful development in solution based standards for a wide range of compounds. Our commitment to quality, robust documentation and regulatory compliance, as well as a full range of capabilities from organic synthesis to inventory management, enable a long-term relationship approach when working with companies that need OEM or custom manufacturing services and solutions.