Last week, FDA issued its latest draft guidance on biosimilar products and implementation of the BPCIA. The draft guidance, titled Statistical Approaches to Evaluate Analytical Similarity, “describes ...

Since the COVID-19 pandemic has forced some members of the U.S. Intelligence Community (IC) to change the nature of their work into a more open environment, it is an opportune time to not only learn ...

The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes. The design of accurate ...

Biotherapeutics require extensive characterization and quality control (QC) testing prior to product release. These tests are resource intensive, time-consuming, and require updating as manufacturing ...

One of the fundamental purposes of biotherapeutic research, development, and production is to assure the safety and efficacy of medicinal products in clinical settings. Analytical tools are critical ...

Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates. The success of the messenger RNA (mRNA) vaccines against the SARS-CoV-2 virus brought ...

Mass spec is poised to fulfill its potential in the QC lab, say researchers who claim that a new intact protein analysis method overcomes challenges that have up to now limited adoption. Growing ...

It is an unfortunate result of being human that we are biased by our first impressions. For example, we are often blinded when we encounter a subject area’s data for the first time. The initial data ...