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CDC issues permit to handle and analyze COVID-19 Biohazard Safety Level-2 clinical trial samples
March 10, 2020
By: Kristin Brooks
Managing Editor, Contract Pharma
QPS, a global CRO providing discovery, preclinical and clinical drug development services, has announced the readiness of an access restricted bioanalysis lab prepared to analyze COVID-19 clinical trial samples. According to the World Health Organization (WHO), there are more than 20 vaccines for COVID-19 in development globally, and several therapeutics are in clinical trials. The WHO guidance classifies COVID-19 as Biohazard Safety Level-2 (BSL-2), which puts it in the same category as other viruses such as the hepatitis B virus (HBV), human immunodeficiency viruses (HIV) and the human papillomavirus (HPV). On March 4th, QPS received a permit from the US Centers for Disease Control and Prevention (CDC), Department of Health and Human Services, for the QPS bioanalysis laboratories in Delaware Technology Park, Newark, DE. This “Permit to Import Infectious Biological Agency, Infectious Substances and Vector” covers the following material: human blood/blood products, other bodily fluids, and tissues that may contain novel coronavirus (severe acute respiratory syndrome coronavirus SARS-COV-2). “In the fight against coronavirus, drug companies need ready access to laboratories equipped to safely manage and analyze samples from ongoing and new clinical trials focused on COVID-19,” said Benjamin Chien, CEO of QPS. “We’ve assembled an isolated, restricted access laboratory ready and available to support the life sciences community in determining the safety and efficacy of potential vaccines and treatments for COVID-19 as quickly as possible.” QPS has taken the proper protective steps to safeguard its employees and sponsorsleveraging rigorous safety and containment procedures for the handling of clinical trial samples, standard operating procedures to ensure safe disposal of infectious wastes, and adequate supplies of personal protective equipment for lab technicians.
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