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

Biologics Quality Control: The Growing Need for Accessible Proteomics

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

Emerging Therapies Drive Analytical Advancements

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

 Analyzing Exabytes

Topic

Feliza Mirasol is the science editor for 

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Articles

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 

The partnership between Waters and Sartorius aims to accelerate speed and increase accuracy in bioprocessing analysis.

Waters and Sartorius Enter Partnership to Improve Bioprocessing Analysis

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

Gentronix Expands Lab Facilities, Increases Testing Capacity

Thermo Fisher Scientific showcases its new mass spectrometry and chromatography solutions at the ASMS Conference on Oct. 31–Nov. 4, 2021. 

Thermo Fisher Launches New Mass Spectrometry and Chromatography Solutions

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

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Part two of this article series shows how traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data of pharmaceutical processes with a reduced number of false alarms. 

Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 2. Practical SPC Rules to Apply on Pharmaceutical Process Data

Meg Rivers is the former senior editor for 

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

Visual Inspection: Seeing Room for Improvement?

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.

Detecting and Determining Quantitation Limits for Impurities

MilliporeSigma’s newly launched Millicell DCI Digital Cell Imager quickly and objectively assesses common cell culture parameters and growth trends for more consistent cell cultures.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes