Blog - Page 3 of 8 - Pacific BioLabs

The Quick Program speeds up 510(k) Reviews

The FDA recently launched a new pilot program called Quality in 510(k) or Quik that allows manufacturers of moderate risk medical devices to use the eSubmitter software program to submit […]

Analytical Chemistry, In Vivo Services, Medical Device, Microbiology

The EU’s Medical Device Regulation (MDR)

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Gene Therapy – The Expanding Pipelines and New Draft Guidance Documents

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 […]

News | July 20, 2018

PBL Purchases QuickPlex SQ 120 MSD Platform

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 […]

Analytical Chemistry, Biologics, Medical Device, Pharmaceuticals

Pacific BioLabs Purchases SciEx TripleTOF 5600 High Resolution Mass Spec System

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 […]

News | June 27, 2018

PBL Expands Analytical Capabilities

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 […]

Medical Device

Reusable Device Cleaning Validation – Three Cycles or One Cycle?

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 […]

Medical Device

FDA Decision to Exempt Certain Class II Devices from 510(k) Premarket Notification

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 […]

Analytical Chemistry, In Vivo Services

Maximum Tolerated Dose (MTD) – An effective preclinical dose determination strategy

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 […]

News | April 17, 2017

PBL Featured in ODT Magazine

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, […]