Early Detection of Viruses in Biopharma

Researchers in Carnegie Mellon University’s Department of Chemical Engineering (ChemE) are collaborating with leading biotechnology company Genentech, a member of the Roche Group, and LumaCyte, a biotechnology instrumentation company based in Charlottesville, VA, to develop an advanced biomanufacturing technology for adventitious agent testing, or testing for unexpected viral infections during the production of biopharmaceuticals.

The research recently received funding from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to develop and test technologies for improving the safety testing of biologic medicines during production and prior to release. This project, which aims to rapidly and accurately detect viral infectivity in biopharmaceuticals, was one of the first four proposals funded by NIIMBL. The team, which includes Carnegie Mellon, Genentech, and LumaCyte, will receive $1.5 million in funding from NIIMBL over 18 months.

When using biological materials such as mammalian cell lines to produce pharmaceuticals, manufacturers face the risk of viruses infecting the batch. Currently, testing for adventitious agents such as viruses happens late in the manufacturing process—but the research team, which includes ChemE Professor Jim Schneider and Adjunct Professor Todd Przybycien, are developing technologies to test biopharmaceutical batches while they are being produced.

“If you don’t find out about infection until very late in the process, you will have wasted a lot of time and money as more downstream equipment and product becomes infected,” says Schneider. “Current infection detection techniques, such as cell-based assays and polymerase chain reaction, can take days to complete. Our methods can provide readout in less than 15 minutes, which enables a routine, continuous type of testing that could detect infections almost as soon as they take hold.”

Rapid DNA analysis has been in development for a number of years by Schneider and Przybycien, who is also a professor of chemical and biological engineering at Rensselaer Polytechnic Institute. Using a rapid DNA analysis technique developed in Schneider’s lab, the team is detecting viruses and bacteria in process streams used to make biologic pharmaceutical projects. By performing rapid electrophoresis, the researchers can separate tagged and untagged DNA in a sample, indicating the presence of virus or bacteria in biologic process streams.

The researchers aim to combine their method with LumaCyte’s LFC and Radiance technology for a faster, more reliable, and more cost-effective solution. LumaCyte’s Radiance and Carnegie Mellon’s patented rapid DNA analysis platform will combine to rapidly detect the presence of virus and/or bacteria in bio process streams.

“The focus of NIIMBL is to translate existing technologies into biomanufacturing contexts,” said Schneider. “One of the top priorities that the industry has identified is rapid adventitious agent screening. As one of the first four projects funded by NIIMBL, this research with LumaCyte and Genentech shows our commitment to collaboration between academia and the pharmaceutical industry."

NIIMBL is an Innovation Institute designed to revolutionize domestic biopharmaceutical manufacturing. Funded through a $70 million cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce, NIIMBL funds and collaborates on innovative manufacturing technologies that bring life-saving and life-enhancing products to market faster and at reduced cost, while maintaining safety and efficacy.

LumaCyte is an analytical instrument development company headquartered in Charlottesville, VA. LumaCyte produces a label-free cell analysis and sorting instrument called Radiance that does not require the use of antibody or genetic labelling for analysis of cells. Applications of LumaCyte’s label-free platform technology include viral infectivity for vaccine manufacturing, cell and gene therapy, cancer biology, infectious disease, and pre-clinical drug discovery.

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New Diagnostics to be Highlighted at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam

A number of companies will be highlighting their new technologies at the 29th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). ECCMID is being held on April 13 – 16, 2019 in Amsterdam, Netherlands. Below you will find prep releases from some of these companies.

Mesa Biotech to Introduce Expanded Molecular POC Testing Portfolio at the European Congress of Clinical Microbiology and Infectious Diseases

Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced it will demonstrate its expanded, novel Accula™ Test System at the 29th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). ECCMID is being held on April 13 – 16, 2019 in Amsterdam, Netherlands and the Accula System will be on exhibit in Booth 1.1C. Mesa Biotech has obtained CE Mark in the European Union (EU), as well as 501(k) clearance and CLIA Waiver from the U.S. Food and Drug Administration (FDA) on both its Accula Flu A/Flu B and RSV tests.

The Accula System, recently named 2019 Frost & Sullivan Price/Performance Global Value Leader, is a palm-sized, reusable dock with disposable test cassettes. The novel molecular test system offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Test results are available in approximately 30 minutes to guide same day treatment decisions. Both the Accula Flu A/Flu B and RSV tests are indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.

"We are excited to introduce our expanded PCR test platform at ECCMID," said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. "As our product offerings continue to increase, we are carefully selecting additional strategic distributors to add to our growing international network."

About Mesa Biotech Inc.

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech's Accula™ System consists of a portable, palm-sized dock and disposable, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. The Accula Flu A/Flu B and the Accula RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). Both products are distributed in the US by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia.

T2 Biosystems and Clinicians to Share Clinical Data in Integrated Symposium and Poster Presentations at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID)

T2 Biosystems, Inc., an emerging leader in the development of innovative medical diagnostic products for critical unmet needs in healthcare, announced today that the Company will host an integrated symposium highlighting key clinical data about the T2Bacteria® and T2Candida® panels at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam on Monday, April 15, at 16:00-18:00 Central European Time (CET). ECCMID will take place April 13-16 at the Amsterdam RAI Exhibition and Convention Center.

Additionally, seven leading clinicians and users of T2Direct Diagnostics™ will offer scientific presentations during ECCMID that will highlight the most recent scientific data on the Company’s FDA-cleared T2Bacteria and T2Candida Panels. The Company will also present the first patient case studies with the T2Resistance™ Panel, which recently received FDA Breakthrough designation and is pending CE mark for commercial availability in Europe. All presentations will demonstrate the potential for these panels to significantly improve infectious disease management for patients in real clinical settings.

“I have seen firsthand how the rapid detection of bacterial and fungal pathogens with T2Direct Diagnostics can improve patient outcomes, better manage broad-spectrum antimicrobial usage and combat antibiotic resistance,” said Neil Clancy, MD, University of Pittsburgh Medical Center, who is one of the integrated symposium speakers.

The T2Bacteria and T2Candida Panels are able to identify sepsis-causing pathogens within 3 to 5 hours directly from whole blood, instead of days required with blood culture based diagnostics. This gives clinicians actionable information much earlier than was previously possible, allowing them to make more informed treatment plans for escalation or de-escalation of antimicrobial therapy.

Dr. Clancy continued, “When diagnosing and treating infectious diseases, time is of the essence. I am proud to be one of the clinicians here at ECCMID using T2Direct Diagnostics and believe that we must continue to spread awareness about this rapid diagnostic technology to improve patient care.”

T2 Biosystems will showcase its latest innovations at Booth #1.22. The Company will also host an educational event, “Rapid Diagnostics Direct from Whole Blood: A Solution for Fast and Appropriate Antimicrobial therapy,” which will be co-chaired by Prof. Karsten Becker, MD, University Hospital Münster and Prof. Emmanuel Roilides, MD Aristotle University of Thessaloniki; and it will include the following presentations:

Integrated Symposium

-- “Rapid Diagnostics Direct from Whole Blood: A Solution for Fast and Appropriate Antimicrobial Therapy,” on Monday, April 15 from 16:00-18:00 CET in Hall D; presenters include: • Prof. Michael Bauer, MD, Jena University (Jena, Germany) • Dr. Cornelius (Neil) Clancy, University of Pittsburgh Medical Center (Pittsburgh, PA) • Dr. Giulia De Angelis, Institute of Microbiology, UniversitàCattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli (Rome, Italy) • Dr. Thomas Walsh, New York Presbyterian Hospital (New York, NY)

Poster Presentations

-- Development of a highly sensitive assay for the detection of carbapenem-resistance genes from whole blood by T2 magnetic resonance, on Sunday, April 14, from 13:30-14:30 CET (Tom Lowery) -- Real-life diagnostic performance of T2Candida among ICU patients with risk factors for invasive candidiasis, on Tuesday, April 16 from 12:30-13:30 CET (Maiken Arendrup) -- The T2Bacteria assay is a sensitive and rapid detector of bacteraemia that can be initiated in the emergency department and has potential to favourably influence subsequent therapy, on Tuesday, April 16 from 12:30-13:30 CET (Christopher Voigt) -- The T2Bacteria Panel is a rapid detector of bacteraemia and has potential to guide therapy in patients with haematological malignancies and haematopoietic stem cell transplantation: a pilot study of non-culture molecular diagnosis, on Tuesday, April 16 from 12:30-13:30 CET (Thomas J. Walsh) -- Evaluation of a molecular technology magnetic resonance for the direct identification of pathogens from blood samples in paediatric patients with suspected sepsis, on Tuesday, April 16 from 12:30-13:30 CET (Paola Bernaschi)

About T2 Biosystems

T2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, and T2Bacteria® Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.

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