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

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Articles

A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments.

Optimizing Tableting Processes with Quality by Design

It's better to catch costly mistakes in the laboratory before they reach the accounting department.

All Eyes Alert

Angie Drakulich was editorial director of Pharmaceutical Technology.

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

Meeting Manufacturing Challenges Tied to Extended-Release Injectables

The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions.

FDA Perspectives: Scientific Considerations of Forced Degradation Studies in ANDA Submissions

Amy Ritter was Scientific Editor, BioPharm International.

In this technical forum, experts describe different methods of rapid microbial testing and their applications.

Rapid Microbial Testing

Mark Leaper is Senior Lecturer, School of Pharmacy, De Montfort University (UK).

An analytical technique that is receiving increased attention in the pharmaceutical industry is atomic force microscopy. We interview Mark Leaper from the UK's De Montfort University to find out more about this technology.

Atomic Force Microscopy

Parametric release and real-time testing use manufacturing data to ensure that products are made according to defined standards. PharmTech talks to Boehringer Ingelheim's Heribert Hausler about these issues.

Parametric Release and Real-Time Release Testing

The authors provide a review of test methodology and standards, including current industry and regulatory proposals, for biological indicator growout times.

Biological Indicator Growout Times: The Impact on Establishing a Reduced Incubation Time Protocol

Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey.

Bioprocessing Trends: Annual Survey Results

In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes