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

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Articles

Standardized testing protocols are crucial for acceptance of single-use systems.

Building Consensus for E&L Testing Standards

The Spark 20M multimode microplate reader has the ability to read 6- to 1536-well microplates and includes a high-frequency xenon flash lamp that can be combined with detection modules.

Multimode Microplate Reader Improves Sensitivity

The Zeiss Smartproof 5 wide-field confocal microscope is designed for applications in quality assurance and quality control, production, and R&D laboratories.

Confocal Microscope for Surface Analysis

There are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).

Statistical Tools to Aid in the Assessment of Critical Process Parameters

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

The US Drug Enforcement Agency (DEA) has granted permission for the import of pharmaceutical-grade cannabidiol to Catalent Pharma Solutions for a feasibility study in conjunction with Kannalife Sciences, according to a company press release.

US Regulators Permit Kannalife Sciences to Import Cannabidiol for Feasibility Studies

The advanced capillary electrophoresis system, Maurice, from ProteinSimple is used for the quantitative analysis of identity, purity, and heterogeneity profiles of biopharmaceuticals.

Capillary Electrophoresis System Optimizes IgG Purity Analysis

The Tacta range of pipettes handle a range of volumes and liquids.

Mechanical Pipettes Have Ergonomic Design

The Medifuge small benchtop centrifuge from Thermo Scientific provides versatility within a compact footprint.

Benchtop Centrifuge Features Hybrid Rotor

Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.

FDA Cites Three Ipca Facilities for Multiple Violations

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes