B.1.1.7, B.1.351, & ...
14th April 2021 Content supplied by: Microbiologics, Inc.
Microbiologics Expands its Virology Services to Support Drug and Vaccine Researchers and Developers
Microbiologics has announced an additional 650 square foot Biosafety Level 3 (BSL-3) facility within its existing building at the company’s global headquarters in St. Cloud, Minnesota. This addition comes just 9 months after announcing the completion of their first BSL-3 laboratory at the company’s San Diego, California facility in August 2020. The additional BSL-3 facility allows for increased capabilities and capacity for Microbiologics to provide anti-infective testing, assay development, and biomaterial production services for highly infectious pathogens, including COVID-19 and other emerging diseases.
Microbiologics is a leading contract research and manufacturing organization (CRMO), partnering with pharmaceutical and diagnostic companies to bring new lifesaving technology, anti-infective drugs, vaccines, and therapeutics to market. Brad Goskowicz, Microbiologics Chief Executive Officer, commented, "Demanding timelines and complex regulatory requirements are prompting pharmaceutical and diagnostic companies to outsource aspects of their R&D and QC functions to a qualified CRMO partner. We’re able to provide end-to-end, highly collaborative support where and when our clients need it, which enables them to bring new products to market rapidly and safely."
Providing a full menu of antiviral testing and assay development services, Microbiologics supports drug, vaccine, and medical device development processes from discovery through post-market surveillance. Examples of these specialized assay services include virus neutralization, hemagglutination, immunoassay development within ELISA platforms, and Single Radial Immunodiffusion (SRID) assays. Microbiologics is currently transferring a SARS-CoV-2 virus neutralization assay for the United States Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, acquired under the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) contract number W911QY-21-C-0012. The company has responded to the COVID-19 global crisis by providing SARS-CoV-2 IVD controls and biomaterials for the development and validation of assays, vaccines, and therapies, as well as providing post-market surveillance testing of COVID-19 vaccines.
Microbiologics has a history deeply rooted in the biological controls industry with highly customizable and scalable manufacturing capabilities and an expansive distribution network. They have extensive expertise in the growth, titration, purification, and production of viruses and microbes in a variety of formats for research, development, and quality control applications. High-titer, highly purified, and inactivated intact virus, as well as synthetic nucleic acid and viral DNA and RNA, are examples of the materials they regularly produce for clients. The company also has a repository of more than 10,000 viral stocks and clinical isolates used for screening antiviral and antimicrobial compounds.
When speaking about the new BSL-3 laboratories, which began construction in February 2021, Goskowicz stated, "Expanding our BSL-3 capacity allows us to continue co-creating and pursuing new ideas alongside our partners without limitation." He added, "At the heart of everything we do is an uncompromising commitment to supporting our partners on the frontlines and creating confidence in science. We care deeply about our clients’ needs and understand the impact their products will have on the lives of people throughout the world. It’s what drives us to continuously push ourselves to find better answers, better solutions, and better ways to serve."
Date Published: 14th April 2021
Source article link: View
B.1.1.7, B.1.351, & P-1 Inactivated Whole