Analytics

David Smith is CMO manager at Glide Pharmaceutical Technologies Ltd.

Courtney LeBlon, PhD, Director of Technical Operations, Ori Biotech.

Stephen Shapka, PhD, Lead Automation Engineer, Ori Biotech.

Articles

Analytical methods need a boost to ensure quality control for cell and gene therapies.

Contamination Control for Cell and Gene Therapies Needs New Analytics

Feliza Mirasol is the science editor for 

Chris Spivey is the editorial director of 

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies: Part 2

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies: Part 1 

Gentronix has expanded it lab facilities and increased capacity for genetic, ocular, and skin toxicology testing.

Gentronix Expands Lab Facilities, Increases Testing Capacity

The increased flow of data from laboratory studies requires a data management strategy to optimize study success. 

Strategic Management is Growing Increasingly Important for Larger Quantities of Generated Data

Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units. 

Visual Inspection: Seeing Room for Improvement?

In spite of perceived similarities, stability testing programs for biologics are far more complex than than those used for small-molecule drugs.

Using Stability Testing Data to Determine Shelf Life

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.

Determining Shelf Life: Reading the Stability Testing Data

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed. 

Sampling and Testing Nomenclature for Pharmaceutical Analysis: A Simplified Approach

Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality. 

Analytical Method Development