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

Knauer has introduced new columns and screening services for the enantioseparation of chiral substances.

Knauer Offers New Separation Columns and Screening Services

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Empty and prefilled syringes must pass a range of quality control tests.

Test Methods and Quality Control for Prefilled Syringes

Anderson Albuquerque is pharma tech lab expert at the Global Pharma Tech Laboratory, Merck SA, Rio de Janeiro, Brazil.

Raphael Lopes is pharma tech lab expert, all at the Global Pharma Tech Laboratory, Merck SA, Rio de Janeiro, Brazil.

Renato BP Pinto is head of the Global Pharma Tech Lab at the Global Pharma Tech Laboratory, Merck SA, Rio de Janeiro, Brazil.

Particle morphology of magnesium stearate, added as an anti-caking agent in a high water‑soluble drug substance, has an influence on the dissolution rate of compressed tablets.


Role of Particle Morphology on Tablet Dissolution Rates

Agnes Shanley is senior editor of Pharmaceutical Technology.

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

Using the Multiple Attribute Method for Process Development and Quality Control

Andrew Johnson is analytical specialist with Gaylord Chemical Co, LLC.

Ashley Jones is analytical chemist with Gaylord Chemical Co, LLC.

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

Testing for Water in DMSO: Exploring Alternatives to Volumetric Karl Fischer Analysis

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.

Managing Biologic Equipment Cleaning

Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

Integrated First-in-Human Service Package for Poorly Soluble Small Molecules

Lonza’s fully automated plate-based PyroTec PRO Robotic Solution accelerates endotoxin testing of parenteral pharmaceuticals.

Robotic Solution Simplifies and Speeds Endotoxin Detection

Cambrex’s expanded quality control laboratory supports generic API development.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes