-- Prolytix, a bioscience manufacturer, has recently announced that it has developed and validated a single method that can simultaneously measure plasma and five distinct tissue matrices. This approach streams the process of analysis and improves its efficacy and precision.
The development of the new method was announced on Prolytix’s LinkedIn account, with a link to the case study containing details about the announcement.
The work was conducted on behalf of one of Prolytix’s clients, who needed a “unique assay” to detect their drug product in plasma, along with five different biological tissues. Each assay needed to be validated with a sensitivity five times lower than the concentration of interest, and the client required an assay to pass on to regulatory agencies to enable them to move into the next phase of drug development.
“This innovative method represents a significant advancement in bioanalytical science,” said John Moriarty, Vice President of Business Development at Prolytix.
“By developing a single assay capable of measuring drug concentration across multiple matrices, we have not only streamlined the analytical process but also provided our client with a robust and reliable solution that accelerates their drug development program.”
The bioanalytical CRO worked within a limited amount of time to quickly develop and validate an assay that could be used to measure the concentration of the drug in plasma, ready to be used in an animal study. The assay would then need to be modified with small adjustments from one tissue to the next. The client was keen for the assay to be robust, with the potential to be developed, validated, and used for other challenge studies in the run-up to their regulatory valuation.
The challenge came from the fact that the drug product produced by the client wasn’t compatible with traditional ELISAs. As a result, scientists at Prolytix were tasked with adapting a commercial activity assay to evaluate the drug product in plasma. The team used similar scientific concepts to transform the commercial assay into a de novo activity assay, which could be used to indirectly measure the client’s drug product in five separate biological tissues. The assay had a lower sensitivity and provided a solution for the client to exceed the requirements needed for their discussions with regulatory authorities.
“This project exemplifies our team’s ability to overcome complex scientific challenges,” said John Moriarty. “We thrive on tackling difficult client requests as it pushes the boundaries of our scientific capabilities and ultimately leads to innovative solutions that benefit the industry as a whole.”
About Prolytix
Prolytix (formerly Haematologic Technologies (HTI)) is a primary manufacturer specializing in the characterization and isolation of plasma proteins that play a role in the regulation of bone metabolism and the coagulation cascade for in vitro research use.
The company’s portfolio includes more than 150 well-characterized, highly-purified proteins, including enzymes, zymogens, inhibitors, and co-factors, along with a complementary selection of polyclonal and monoclonal antibodies, an extensive line of bovine, murine, and human-source plasma proteins (including coagulation factors, platelet and bone proteins, and initiators), and factor-deficient plasmas.
Contact Info:
Name: Andrew Jackson
Email: Send Email
Organization: Goprolytix
Website: http://goprolytix.com
Release ID: 89143008
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