Viral Clearance Studies

In the rapidly evolving biopharmaceutical industry, ensuring product safety and efficacy is paramount. With the increasing risk of viral contamination, particularly during the production and preparation of biopharmaceuticals, effectively eliminating potential viral contamination has become a focal point for the industry and regulators. Virus Clearance Studies (VCS), as a key process for ensuring the safety of biopharmaceuticals, are undeniably crucial.

HyQure Biotech has been deeply involved in VCS for biopharmaceuticals for over 5 years. Leveraging its extensive experience with over 100 successful IND/BLA applications (including those from the US FDA, EU EMA, China NMPA, and Japan JPMA), we can provide comprehensive VCS services for your drug products.

We have extensive experience in VCS for various types of biopharmaceuticals, including recombinant proteins, gene therapy, antibodies, vaccines, and blood-derived products. Whether your product is in early or late-stage clinical trials, or in the market application stage, we can design the best validation protocol to meet regulatory requirements, ensuring a successful application.

Regarding process selection, we possess extensive data and, based on orthogonal design principles and past data accumulation, will provide you with a process selection solution that aligns with your current process status and regulatory requirements.

Regarding process selection, we possess extensive data and, based on orthogonal design principles and past data accumulation, wllprovide you with a process selection solution that aligns with your current process status and regulatory requirements.

Regarding virus selection, we will provide indicator virus selection advice based on your product's risk profile, considering factors such asdifferent physicochemical properties, resistance levels, and contamination risks.