Safety and lot release testing

Viral safety testing is an essential part of the pharmaceutical and biotechnology industries, particularly for products such as vaccines, antibody-based medications, and gene therapies. The purpose of these tests is to ensure that any product administered to patients is free from viral contamination, which could pose serious health risks. These tests help prevent the transmission of infectious agents, and ensure compliance with regulatory standards set by agencies such as the FDA and EMA.

 

The COVID-19 pandemic had a profound impact on viral safety testing. The urgency and scale of the pandemic highlighted the importance of robust viral safety measures, driving several changes and innovations in the way viral testing is conducted for pharmaceutical products.

At hylabs we perform a variety of viral safety tests based on EP and USP, including viral clearance assays, PBRT for the detection of retroviral contamination, detection of specific viruses using real-time PCR, In-Vitro Adventitious Virus detection assay in cell cultures. Tests involving live viruses are performed in our Virology lab, which is ISO 9001 and ISO 17025 accredited, cGMP-compliant and operates at a BSL-2+ facility.

 

Viral safety tests	Microbiological tests	Genetic assays	Other key assays
In vitro adventitious agents Retroviral infectivity assays Retroviruses detection (PBRT) Specific virus detection (Real-Time PCR)	Sterility Endotoxin (LAL) Mycoplasma	Sequencing Gene copy number Gene expression Cell identity (BARCODE)	Residual DNA Residual Protein Next Generation Sequencing Biodistribution

For more information:

Natalie Orlovetskie: natalie-mbc@hylabs.co.il | 052-6474969

Hadas Alisar Varshavski: hadas@hylabs.co.il  | 073-733705256

Nurit Blum: nuritb@hylabs.co.il  | 073-2524550