Case Studies
Analytical Case Studies
Answers to Antifoaming Agent Dilemma
A mid-sized biotechnology company approached EAG Life Sciences (formerly Cyanta) regarding their new large molecule product in late phase development. The company was optimizing the commercial manufacturing process for their new product which included the use of a novel PEG based antifoaming agent. In order to comply with FDA guidance for the new marketing applications, the company needed to quantify the antifoaming agent in final product and demonstrate that any residual presence was not a health concern.
EAG Life Sciences began by developing a method by LC/MS to detect and quantitate the presence of the antifoaming agent at the ppb level. Additionally, EAG Life Sciences coordinated with a toxicologist to determine the potential hazards of the antifoaming agent at a variety of concentrations. In this process EAG was able to demonstrate that its method was able to detect the presence of the antifoaming agent well below the level at which a toxicological event may occur. Subsequently, EAG validated the method per regulatory guidance and was prepared to analyze QC samples when commercial production began.
Expectations are Exceeded on Strict Deadline
A client came to Cyanta with 95 methods that required development using current technologies by GC/MS, LC/MS, replacing antiquated, inefficient analytical techniques due to an audit finding. The client had been working on the finding for 6 months and was in jeopardy of missing the deadline. We developed the methods in 13 months, 5 months before the client's deadline. The client is continuing, to this day, to use Cyanta as their preferred vendor.
Responsiveness Saves Manufacturers Millions
During a routine audit by the FDA, unknown contaminant particles were discovered in a
manufacturer's process. The FDA ordered a temporary shut down of the facility until the
contaminants could be identified. A lengthy shut down would potentially cost the manufacturer millions of dollars a day. Late on a Friday afternoon, the desperate manufacturer contacted Cyanta for assistance in identifying the contaminants. After identifying the full scope and specific needs of the customer, we communicated the possible solutions and our goal of a 3-day turnaround.
More than 20 samples were received late Saturday morning, and the push was on. We put the contaminants through a battery of tests including FT-IR and SEM-EDXA among others. The particle contaminants were quickly identified, and the results reported to the manufacturer by Sunday afternoon.
With the results, the manufacturer was able to identify the source of the contamination and was able to take measures against the problem occurring again. Satisfied with the results and the solution, the FDA permitted the manufacturing to resume. Cyanta's dedication, responsiveness and technical expertise was able to save the manufacturer millions of dollars while minimizing interference with their production.
Elimination of Medical Device Leachables
A medical device company contacted Cyanta regarding a problem with one of their products. It was believed that solvent contact with their device was causing chemicals to leach from the device's foam components into the rest of the device. This problem was preventing the product from being approved for use on the market. It was Cyanta's job to identify and quantify the leachables so that appropriate corrective measures could be taken.
Cyanta developed an appropriate analytical protocol involving soxhlet extraction followed by HPLC, GC/MS, LC/MS and UV-Vis Analysis. Using these techniques, we were able to identify several unexpected impurities and determined that the impurities were present in the drug product at approximately 0.5 ppm.
With this information in hand, we were able to make recommendations to the device manufacturer, who was able to modify the foam to eliminate the presence of the leachables. The modifications allowed the product to be successfully launched on the market.
