The European Union published the new Medical Device Regulation (MDR) on May 5th, 2017 and it is expected to be enforced starting May 25th, 2020.  This new regulation repeals the […]

Gene therapy has broken out of its chains. In 2017 alone, Kymriah (Novartis), Luxturna (Spark), and Yescarta (Kite Pharma/Gilead) received FDA approval.  The number of small gene therapy companies is […]

Pacific BioLabs has purchased and validated a QuickPlex SQ 120 MSD instrument and we are now accepting requests for MSD studies.  The instrument will be used for immunogenicity testing, biomarker […]

The SciEx TripleTOF 5600 Mass Spectrometer is known for delivering excellent sensitivity and linear dynamic range. In highly complex matrices, the TripleTOF 5600 provides high-resolution of low- abundance analytes which is just […]

In the spring of 2018, PBL purchased a SciEx 5600 TripleTOF mass spectrometer. That instrument is now fully validated and ready to use for regulated studies. Please see PBL's blog […]

Pacific BioLabs have been performing reusable device cleaning validations for over a decade.  Traditionally, PBL has performed cleaning validations by testing three devices over three different cleaning cycles giving a […]

On July 11th, 2017 the FDA announced that they have determined that certain class II device will no longer meet the premarket notification requirements under section 510(k) of the Federal […]

The path to drug approval involves drug discovery and drug development. In drug discovery, compounds are screened for favorable biological activity against a target(s) and lead compounds are chosen to […]

Orthopedic Design and Technology Magazine featured Pacific BioLabs in their recent March/April issue.  The article discussed new medical device technologies and the testing challenges incurred with these more advanced devices.  PBL explains the cleaning, […]

With the prevalence of diabetes increasing worldwide at unprecedented rates in recent decades, the development of relevant drug therapies have expanded as well. Medications for regulating blood glucose levels are […]