USP 787 Test for Visible Particulate Matter in Therapeutic Protein Injections

EUROLAB laboratory provides testing and compliance service within the scope of USP 787 standard. This standard was developed to address the limitations of the USP for therapeutic proteins and provides a smaller volume testing framework to address proteinaceous particles and the immunological effects of particle load below 10 µm.

USP 787 requires manufacturers of injecting and infusing pharmaceuticals and biopharmaceuticals to comply with strict guidelines regarding the amount of particles present in final drug products. This arrangement focuses specifically on the development of more costly protein formulations and the unique sensitivities that exist in producing protein-based therapeutics.

This standard specifies the following:

• Especially for protein-based therapeutics (not all injectable forms),
• Final dose and packaging analysis,
• Smaller test product volumes,
• Smaller test aliquots
• Defines the "natural" form of particulate matter,
• Explains preparation and test methods,
• Defines maximum particle load limits.

EUROLAB assists manufacturers with USP 787 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.