At a basic level, Venture Capital (VC) funding can be described as financing provided to startups or other relatively early-stage business that are perceived to have significant growth potential. VC […]

Here at PBL, we work with many medical device companies, and no matter whether these companies are new or established, there still seems to be common questions among them. Namely: […]

FDA Registration, New Regulations, and GMP Standards Historically, pharmacies have been able to compound drugs for individual patients or in small batches. These compound pharmacies create and mix drugs customized to […]

  At PBL we hear a lot of questions from medical device clients regarding FDA material and chemical characterization requirements. To address, and hopefully alleviate some of this confusion, we’ll be […]

PBL is offering support to biocompatibility clients through assistance with test and method selection for biocompatibility testing. As regulatory bodies, such as the FDA, push for more complex testing, it […]

The USDA performed an annual facility inspection of PBL on June 11. The inspection went smoothly, with no findings issued. Congratulations to the Pacific BioLabs IACUC and everyone involved. […]

According to the ICH guideline Q1A(R2) adopted by the FDA and EMA, the goal of stability testing is to demonstrate “how the quality of a drug substance or drug product varies with […]

Immunogenicity, defined as the ability of a substance to produce an immune response, is key to a successful and safe biopharmaceutical drug development program. Therapeutic Antibodies, enzyme therapies, peptides and […]

According to the ISO standard 10993, a medical device should be biocompatible i.e. not induce any adverse effects when it comes in contact with the patient. The standard provides a […]

Pharmacokinetic (PK) and Toxicokinetic (TK) analysis is an important aspect of drug development.  These studies may be exploratory in nature or more extensive and formal.  Understanding the bioavailability, exposure, half-life, […]