Analytical Chemistry, Medical Device, Microbiology, Toxicology

FTIR – A Helpful Tool to Determine Chemical Composition

Fourier-transformed infrared spectroscopy, also known as FTIR, is a method of analyzing both organic and inorganic materials, and can provide […]

Analytical Chemistry, Medical Device, Microbiology, Toxicology

Updates to EU’s New Medical Device Regulation (MDR)

As you may be aware from our previous blog post, the European Union published the new Medical Device Regulation (MDR) […]

Medical Device

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 […]

Analytical Chemistry, Medical Device, Microbiology, Toxicology

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 […]

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Gene Therapy – The Expanding Pipelines and New Draft Guidance Documents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 […]

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 […]

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 […]

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 […]

Biologics, Medical Device, Pharmaceuticals

Insulin and Glucagon Bioassays

With the prevalence of diabetes increasing worldwide at unprecedented rates in recent decades, the development of relevant drug therapies have […]