Analytical Testing

SCALE-UP & MANUFACTURING – Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact

Anil Kane, PhD, MBA, explains how many smart formulation process or engineering solutions can be applied to overcome challenges of the material properties to successfully manufacture quality products at the development and commercial scale with minimum to no clinical or regulatory impact.

ASSAY VALIDATION – Biomarker Assay Validations – A Time for Change?

John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.

SAMPLE PREPARATION MARKETS – Automation & Application Trends Drive Growth in Sample Preparation Markets

Christi Bird indicates sample preparation remains a critical task in many research and testing workflows across biopharmaceutical, basic research, clinical, and industrial applications. While the market lacks the hype and excitement of NGS, CRISPR/Cas9, or the microRNA and epigenetics boom several years ago, the sample preparation market will always be a slow and steady gainer on an already large market size.

BIOMARKERS – FDA’s Design Control Requirements for Biomarkers in Drug Development

Kaiser J. Aziz, PhD, says the availability of validated biomarker-drug companion products will enable the molecular diagnostics and pharmaceutical industries to develop and rely on new genomic biomarkers in order to elucidate disease pathways, stratify patient populations, and monitor safe and effective use of these products.

EXCLUSIVE ONLINE CONTENT

8/7/2019

Cambrex to be Acquired by the Permira Funds

Cambrex Corporation recently announced it has signed a definitive agreement to be acquired by an affiliate of the Permira funds in a transaction valued at approximately……