Biologics
Gene Therapy – The Expanding Pipelines and New Draft Guidance Documents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 […]
News
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 […]
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 […]
News
PBL Expands Analytical Capabilities
In the spring of 2018, PBL purchased a SciEx 5600 TripleTOF mass spectrometer. That instrument is now fully validated and […]
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 […]
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 […]
News
FDA’s GLP Inspection of PBL Had No Observations
Between October 25th and 27th, the FDA inspected Pacific BioLabs for GLP compliance. The FDA inspector looked at the following […]
News
Thomas Chambers, Ph.D. Joins Pacific BioLabs as Associate VP of Quality Assurance
Pacific BioLabs is proud to announce the addition of Thomas Chambers as the Associate Vice President of Quality Assurance. Dr. […]
Analytical Chemistry, Toxicology
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 […]
News
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 […]