Contamination & Impurity Testing
Safety testing is essential to the pharmaceutical and biotechnology industries, particularly for products such as vaccines, antibody-based medications, and gene therapies. These tests aim to ensure that any product administered to patients is free from microbial and 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.
At hylabs we perform a variety of safety tests based on EP and USP, including microbial and viral clearance assays, PBRT for the detection of retroviral contamination, microbial and viral detection based on advanced technics and In-Vitro Adventitious Virus detection assay in cell cultures. Designed to meet the rigorous demands of industrial and regulatory standards, our facility is accredited under GMP, ISO 9001 and ISO 17025, ensuring the highest levels of quality and technical competence.
Viral Clearance & Viral Disinfection
Our virology laboratory is ISO 9001 and ISO 17025 accredited, cGMP-compliant and operates at a BSL-2+ facility. We perform tests and design unique projects, based on ASTM and ISO standards, for our variety of customers […]
Cell Culture
Hylabs provides GMP assays and custom cell culture services to our customers upon request. For custom experiments, we may assist in planning the requested experiments in order to meet your goals. Among the services offered […]
Viral Detection
Specific viral detection (GMP certified) Our method for detection of specific viral targets using Real-time PCR is based on TaqMan technology so that each virus is detected using a specific set of primers and probe […]
Water tests
Water is widely used as raw material, inactive ingredient, active pharmaceutical ingredients (APIs) as well as in cleaning applications. The testing of water samples from a water system is critical to the ongoing control […]
Mycoplasma Testing
Mycoplasma is the smallest free-living, self-replicating organism, found mostly on the outer surface of the cell membrane and rely on their hosts for nutrients. Consequently, mycoplasma has adverse effects on the characteristics of a contaminated […]
Disinfectant Efficacy
The purpose of this study is to determine the efficacy of the disinfectant reagents used for the sanitization of surfaces in controlled manufacturing facilities and performed according to USP <1072>. The disinfectants efficacy is evaluated […]
Cleaning & Disinfection
The manufacturing of reusable medical device must accompany detailed instructions on how to reprocess the device between patient uses in the hospitals. Cleaning of the device is a critical step in reprocessing of any device […]
Bioburden
Materials and products that are to be sterilized should be examined to determine the level of bioburden (microbial load/count) in the article, prior to its final sterilization. Monitoring of in-process bioburden of pharmaceutical components and […]
Sterility & LAL
Sterility test: We are considered to be the most critical lab in Israel for sterility test product release. That specialty in sterility testing is due to our vast experience in adopting rapid methods for sterility […]
qPCR testing
Gene expression (GMP certified) Reverse transcription-quantitative PCR (RT-qPCR) is considered the gold standard for accurate, sensitive, and fast measurement of gene expression. The RT-qPCR method for gene expression determination is based on relative or absolute […]