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

Articles

The new microscope gives fast, deep, and clear images for live observation over long periods and allows scientists to study a larger range of applications.

New GE Healthcare Microscope Offers Enhanced Resolution

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Fumiko Tamura is associate manager, GSK, CMC Regulatory Affairs, Tokyo, Japan

Hatsuki Asahara is department manager with GSK, CMC Regulatory Affairs, Tokyo, Japan

Adam Watkins is scientific leader, GSK, product development and supply, David Jack Research Centre, Ware, UK.

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies. 

Risk-Based Intermediate Precision Studies for Analytical Procedure Validation

Novartis revealed results from two new clinical trials indicating that Entresto (sacubitril/valsartan) significantly improves measures of cardiac structure and function in heart failure with reduced ejection fraction.

New Trial Results Demonstrate Potential of Entresto in Reversing HFrEF damage

Anna Novikova, PhD, is a process analytical technology scientist at Fette Compacting, anovikova@fette-compacting.com.

At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.

The Road to Real-Time Release: At-line NIR Testing

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

In this interview, the main uses and benefits of NIR spectroscopy in tableting are discussed.


Putting NIR to Good Use in Tablet Formulation and Manufacture

Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.


Regulating Excipient Quality, No Mean Feat

As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.


Container Closure Integrity Testing of Finished Sterile Injectable Product

Wendy Saffell-Clemmer, BPS, is research director, R&D and innovation, at Baxter Healthcare.

Elizabeth Joseph is research scientist II, BioPharma Solutions at Baxter Healthcare Corporation.

The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.

Stability Indicating Methods for Aluminum Adsorbed Vaccine Products

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

The editors welcome technical article contributions from the bio/pharma industry.

Plan Now to Share Your Expertise in 2020

Protagen Protein Services’ recently acquired Brucker Tensor II IR spectrometer significantly expands the company’s analytical capabilities.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes