This week addressed AI accountability, CPHI award winners, NFC anticounterfeiting, first-in-class FDA approvals, and a shelved FDA voucher pilot lead this week’s roundup.
News|Articles|June 3, 2020
- Pharmaceutical Technology\'s In the Lab eNewsletter-06-03-2020
- Volume 15
- Issue 6
New SARS-CoV-2 Molecular Quality Control
The quality control from ZeptoMetrix is formulated with purified intact viral particles that have been chemically modified to render them non-infectious and refrigerator stable.
Advertisement
On May 5, 2020, ZeptoMetrix announced its new, ready-to-use NATtrol, a SARS-CoV-2 molecular quality control for laboratory QC and test validation.
According to a company press release, the quality control is formulated with purified intact viral particles that have been chemically modified to render them non-infectious and refrigerator stable, including:
- NATtrol SARS-CoV-2 Positive Control
- Product Number: NATSARS(COV2)-ERC
Complementing the release of the positive control is a negative control formulated with human A549 cells:
- NATtrol SARS-CoV-2 Negative Control
- Product Number: NATSARS(COV2)-NEG
"Due to the unprecedented COVID-19 pandemic, we were tasked to develop and deploy reliable, user-friendly commercial solutions for ready-to-use, non-infectious SARS-CoV-2 full process molecular quality controls under accelerated timelines,” said Shawn R. Smith, president and CEO of ZeptoMetrix, in the press release. “Today, I am extremely proud to announce that ZeptoMetrix has launched such controls - containing purified intact viral particles of actual SARS-CoV-2 that provide laboratories, hospitals and research facilities with essential external run controls to help ensure the reliability of COVID-19 testing.”
Source:
Articles in this issue
over 6 years ago
Bio-Rad Launches Anti-Certolizumab Pegol Antibodiesover 6 years ago
Improved Pharma to Expand its Microscopy Servicesover 6 years ago
Good Automation Practices in the Laboratoryover 6 years ago
Contamination Drives a More Concerted Approach to Genotoxinsover 6 years ago
Testing for Nitrosamines in Pharmaceutical Drugsover 6 years ago
Avantor OmniTop Sample Tubes Offers Adjustable Volume SamplingAdvertisement
Related to this article
Cole and Jaenisch explain why defending against AI poisoning in pharma manufacturing calls for a data steward role, immutable instruction ledgers, and automation.
Gloveless isolators don’t end interventions. Learn to assess intervention dependency in robotic aseptic filling and when glove ports are justified.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how the company’s product is worth the investment by protecting products and patients.
The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
Regulators will test pharma companies against their own internal AI policies. Jaenisch, Muraru, and Pandey explain how to build defensible, inspection-ready AI practices.
Terry Katz, CEO and co-founder of ForgeStop Technology Corporation, explains how its connected technology can enhance anticounterfeiting and how data are handled within the product.
Celtic Renewables won the CPHI Award for Sustainable Pharma Excellence for its green chemicals used in pharmaceutical manufacturing. Bettina Brierley, chief commercial officer, talks about the adoption, capacity, and pricing of biosolvents.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Signs Point to FDA Shelving Priority Voucher Pilot, Stalling Fast-Track Drug Reviews
2
France Remains One of Europe’s Leading Biotech Funding Hubs
3
The Impact of Excipients on Continuous Manufacturing and the Risk of Nitrites
4
PharmTech AI Pulse Check: Who's Accountable When a Vendor's AI Model Changes?
5