Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Emerging Therapies Drive Analytical Advancements

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Analyzing Exabytes

Effective analytics will eliminate failures, deviations, and non-conformances.

Determination of Higher Order Structure and Hydrogen Deuterium Exchange by LC–MS

November 01, 2012

Hydrogen deuterium exchange by mass spectrometry is a powerful analytical approach that can be used to map higher order structures of proteins.

Developing a Comprehensive Approach for Preventing Metal Contamination of Pharmaceutical Products

November 01, 2012

This discussion aims to outline an approach to metal contamination prevention that should achieve a level of control acceptable to all stakeholders.

Moisture Matters in Lyophilized Drug Product

November 01, 2012

Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.

A Novel Process for Developing Fully Human Monoclonal Antibodies

November 01, 2012

The authors describe a process for generating high affinity, fully human antibodies in culture.

Improving Technology Transfer

November 01, 2012

This article focuses on the growing need for effective data management in the life sciences industry-especially among smaller pharmaceutical manufacturers.

Analytical Applications

November 01, 2012

Developing analytical methods and performing related testing is crucial for ensuring the quality of a pharmaceutical product.

Using a Systematic Approach to Select Critical Process Parameters

November 01, 2012

Critical process parameters (CPPs) and their associated process controls are crucial to drug development and process validation and to the evaluation of every manufacturing unit operation.

Nuclear Magnetic Resonance as a Bioprocessing QbD Application

November 01, 2012

The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.

Equipment and Processing Report

October 2012 Editor's Picks: Products from UFP Technologies and Mettler Toledo

October 17, 2012

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2012 edition from UFP Technologies and Mettler Toledo.

Integration of Less-Formal Risk Assessment Tools into Change Control

October 02, 2012

Managing risk in biopharmaceutical operations is of utmost importance for patient protection.