Life Science and Medicine News & Articles | Contract Laboratory's Outsource! e-magazine

Life Science and Medicine

Endotoxin Testing: Methods, USP <85> Requirements, and Industry Implications

By Trevor Henderson | May 6, 2024

Endotoxin Testing performs a crucial role in the pharmaceutical and medical device industries for ensuring product safety and regulatory compliance.

his image shows a scientist working with a Limulus Amebocyte Lysate (LAL) kit, pipetting a clear liquid into test tubes, set against a backdrop of a well-equipped lab.

Proteins and Peptide Testing: Methods, Applications, Safety and Quality

By Swathi Kodaikal | May 6, 2024

Accredited third-party protein testing labs uphold the highest QA standards, ensuring the safety and efficacy of food, drugs, and biotherapeutics

Female researcher wearing PPE examines a test tube filled with liquid.

Roche Receives FDA Approval for Molecular Test to Screen for Malaria in Blood

By Science Technology | Apr 9, 2024

Intended for screening blood, organ, and tissue donors, the new test will improve blood safety and availability Roche announced FDA approval of cobas® Malaria test for use on cobas® 6800/8800 Systems. The test aids in reducing risks of patient infection from...

Computer image of red blood cells and a pathogen

Webinar: Preformulation Coming Soon to a New Compound Entity (NCE) Designed by You

By Editorial Team | Apr 9, 2024

Join us as Brent Hilker, Manager, Preformulation CoreRx explains the techniques and challenges associated with today's drug development

Laboratoy glassware filled with clear liquids

Sterility Testing: Ensuring Safety in Critical Industries

By Trevor Henderson | Apr 4, 2024

Ensuring product sterility is vital for patient safety, regulatory compliance, and quality assurance across pharmaceutical, medical device, and biotech sector

a laboratory scene where scientists are focused on conducting sterility testing

CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs

By Pam Wertalik | Feb 20, 2024

FOR IMMEDIATE RELEASEJanuary 31, 2024 The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) As CDRH moves into 2024 and beyond, the Center intends to initiate the reclassification process for...

FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made

By Science Technology | Feb 20, 2024

In recent years, the FDA has identified several concerns with laboratory developed tests ( LFTs)

A Comprehensive Guide to AAMI Medical Device Testing

By Pam Wertalik | Jan 18, 2024

Learn more about the rigorous assessment processes defined by AAMI standards to ensure that medical devices meet the necessary safety, efficacy, and performance benchmarks

2 scientists working in an analytical lab

ASK THE LAB EXPERT: The Complex Nature of Drug Formulation: Stories from a Formulation Lab

By Marnie Willman | Oct 18, 2023

Drug formulation is and continues to be challenging. Every product is different. Every drug behaves differently based on its physicochemical properties. Understanding those properties through preformulation and in vitro permeability testing is important in designing an appropriate dosage form.

Therapeutic Goods Administration (TGA): Ensuring the Safety and Quality of Therapeutic Products in Australia

By Trevor Henderson | Sep 27, 2023

The Therapeutic Goods Administration, or TGA is a division of the Australian Government Department of Health. The TGA is responsible for regulating therapeutic goods, like prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.