Authors



Paul C. DeRose

Latest:

NIST Fluorescence-Based Measurement Services

Fluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.


Lili Wang

Latest:

NIST Fluorescence-Based Measurement Services

Fluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.


Clay Seese

Latest:

Using Digital Tools to Optimize Facility Design

Digital tools, such as building information modeling (BIM) software, improves efficiency for optimizing pharmaceutical facility design.


SciLabware

Latest:

WHEATON® Primary Packaging Solutions manufactured by SciLabware

WHEATON® primary packaging solutions manufactured by SciLabware SciLabware Limited, a company of DWK Life Sciences, is one of the world’s leading manufacturers of high quality primary packaging solutions to the diagnostic and pharmaceutical industries across the globe.


Peter Kosiol

Latest:

Continuous Processing: Challenges and Opportunities of Virus Filtration

Requirements for virus filtration must be considered in developing continuous downstream processes.


Rohit Bansal

Latest:

Ensuring mAb Stability Through Modeling

Ensuring the stability of biotherapeutics can be achieved through kinetic models that study aggregation and fragmentation.


Yasvanth Ashokraj

Latest:

Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.


Prashant Modak

Latest:

Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.


Kalpesh Sawant

Latest:

Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.


Praveen Date

Latest:

Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.


Swati Laud

Latest:

Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.


BioAnalytix

Latest:

Advanced Analytical Approaches for Accelerated Development of Gene Therapy Products

Download the White Paper and learn how detailed characterization can guide successful development of gene therapy products.


Fette

Latest:

Raising the Bar on Tablet Manufacturing

-- Innovations in Tablet Press Technology -- Containment for Tableting: Best Practices -- Direct Tableting a Mixture of a Powder Matrix and API Loaded Pellets


John Wasylyk

Latest:

Spectroscopy Facilitates Lean Analysis

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.


Bob Wethman

Latest:

Spectroscopy Facilitates Lean Analysis

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.


Ming Huang

Latest:

Spectroscopy Facilitates Lean Analysis

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.


Magdalena Krapf

Latest:

Fundamentals of GMP Warehouse Design

Storage and retrieval methods and the unique requirements found in building codes are crucial considerations.


Martin Koeberle

Latest:

A User-Friendly Approach to Developing an Extended-Release Product

The challenge of achieving sustained delivery of an active ingredient or nutrient can be achieved with extended-release formulations.


LIGHTHOUSE Instruments

Latest:

LIGHTHOUSE Instruments Launches New Products for Robust Headspace Data Generation at the CPHI in Barcelona

LIGHTHOUSE Instruments introduces new technology for robust headspace data generation and areas of application.



Barrett Fallentine

Latest:

Mind the Gap: Tech Transfer from Early Stage Cell Culture to Phase I Clinical Manufacture

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.


Daniel R. Matlis

Latest:

Has Outsourcing Derailed PAT and QbD?

Quality management requires more effort in a complex supply chain.


Valerie Theobald

Latest:

Emerging Therapies Test Existing Bioanalytical Methods

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.


Jenifer Vija

Latest:

Emerging Therapies Test Existing Bioanalytical Methods

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.


Jessica St. Charles

Latest:

Emerging Therapies Test Existing Bioanalytical Methods

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.


Christina Satterwhite, PhD

Latest:

Emerging Therapies Test Existing Bioanalytical Methods

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.


Marcia Maier

Latest:

Analysis of Sub-Visible Particles

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.