Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Emerging Therapies Drive Analytical Advancements

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Analyzing Exabytes

Effective analytics will eliminate failures, deviations, and non-conformances.

AQbD Adds Rigor to Method Development

November 15, 2014

Analytical procedures and method validation should be developed with a structured and rigorous approach.

Validation of a Multiplex Bead-Based Assay

November 15, 2014

The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.

Rapid Screening for Elemental Impurities using ICP-MS

November 15, 2014

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

Standardizing Data Management

November 15, 2014

Industry players form Allotrope Foundation to solve analytical data management problems.

Advances in Analytical Technology

November 15, 2014

Recent technology introductions demonstrate that accuracy, efficiency, and usability are top of mind for pharmaceutical industry professionals for analytical instruments.

MedImmune Acquires Definiens

November 04, 2014

MedImmune enters into an agreement to acquire the image analysis and data mining company.

Analytical and Precision Balance Performs Common Weighing Applications

October 10, 2014

A range of balance models cover a weighing capacity from 60 to 8200 grams.

Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach

October 02, 2014

A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

Marrying Big Data with Personalized Medicine

October 02, 2014

Data analytic strategies can help companies capitalize on personalized medicine.

The Role of Normal Data Distribution in Pharmaceutical Development and Manufacturing

October 02, 2014

Review challenges in the use of normality testing situations and recommendations on how to assess data distributions in the pharmaceutical development manufacturing environment