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

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

Articles

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.


The Fundamentals of Dissolution Testing

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.


Overcoming Bioavailability ‘Roadblocks’ with LBDDS

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

Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution. 

Distribution of Data: The Central Limit Theorem

Aloka Srinivasan, PhD, is Principal and Managing Partner, Raaha LLC.

The author provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in the API or drug product, and avoiding negative product regulation late in the development and/or marketing process, including expensive recalls. 

Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development

Chintan Patel is researcher at Cadila Healthcare Ltd.’s Zydus Research Center in Ahmedabad, Gujarat, India

Gayatri Patel is associate professor of pharmaceutics and pharmaceutical technology at Charotar University of Science and Technology, Changa, Gujarat, India

Sanjay Bandyopadhyay is vice president at Cadila Healthcare Ltd.’s Zydus Research Center in Ahmedabad, Gujarat, India;

Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.

Optimizing Manufacturing Based on the Storage Stability of Pegylated Products

PPD is expanding its bioanalytical lab in Richmond, VA, to enhance its immunochemistry, biomarker, and chromatography services.

PPD Expanding Bioanalytical Laboratory Capabilities

Cell DIVE is a new cell imaging technology from GE Healthcare that allows for more precise biomarker analysis.

Cell Imaging Tech from GE Healthcare Offers Precise Biomarker Analysis

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.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes