As devices become more complex, biocompatibility and material evaluations must necessarily become more complex and thorough as well. Allergic and immunogenic reactions are a serious safety concern not only for […]

For anyone in the medical device or pharmaceutical fields, it's important to stay up to date on current Good Good Manufacturing practices.In January, the US FDA published a draft guidance […]

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 […]