Analytical Chemistry, Medical Device
Chemical Characterization of Medical Devices: An Overview
At PBL we hear a lot of questions from medical device clients regarding FDA material and chemical characterization requirements. To […]
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Analytical Chemistry, Pharmaceuticals
What is Stability Testing?
According to the ICH guideline Q1A(R2) adopted by the FDA and EMA, the goal of stability testing is to demonstrate “how the […]
Biologics
The Importance of Immunogenicity Testing in Biotherapeutic Development
Immunogenicity, defined as the ability of a substance to produce an immune response, is key to a successful and safe […]
Analytical Chemistry, Medical Device
A Note on Chemical Characterization
According to the ISO standard 10993, a medical device should be biocompatible i.e. not induce any adverse effects when it […]
Analytical Chemistry, Pharmaceuticals
PK Studies at PBL
Pharmacokinetic (PK) and Toxicokinetic (TK) analysis is an important aspect of drug development. These studies may be exploratory in nature […]
Medical Device
Toxicologists Weigh in on Biocompatibility
Medical Device biocompatibility, once considered just a "box-checking" activity, continues to become more complex. This was the focus of a […]
Biologics
Botulinum toxin A versus B. What is the Difference?
Have you ever wondered what the difference is between the different types of botulinum toxin?
There are seven distinct variations of […]
Medical Device
Why Device Makers Can Benefit from Increased Use of CROs
Increasingly, device makers are discovering what pharmaceutical companies have known for many years – that using CROs to support regulatory […]
Microbiology
Antibacterial Textile Testing – Prove That Your Product Kills Bugs
Demand in the market for quality textiles that meet consumers’ demands for comfort and freshness has been increasing. Antibacterial performance […]
Analytical Chemistry, Pharmaceuticals
PBL Expands Facility to Increase Stability Chamber Capacity
Recently, there has been much excitement and activity here at Pacific BioLabs regarding the future dedicated stability suite. This long […]