Articles | Pharmaceutical Outsourcing - The Journal of Pharmaceutical & Biopharmaceutical Contract Services

Avoiding Pitfalls during Technology Transfer of Cell Culture Manufacturing Processes in the Pharmaceutical Industry – Mitigating Risk and Optimizing Performance
Thursday, March 28, 2013

Since the early 1980s, biotechnology products have shaped the pharmaceutical industry. A large number of monoclonal antibodies and therapeutic ... read more
Insights Gained into the Identification, Qualification and Utilization of CRO Laboratories in Extractables and Leachables Studies
Wednesday, March 27, 2013

During their manufacture, storage and use, pharmaceutical drug products come into contact with polymeric materials, components and systems. Although... read more
CMC Development Strategies for Small Pharma
Wednesday, March 27, 2013

A significant trend in the pharmaceutical industry is the increasing proportion of early drug development carried out in smaller organizations, as ... read more
How a Training Strategy Can Improve Clinical Trial Performance
Wednesday, March 27, 2013

Pharmaceutical companies are facing the increasingly-stressful challenge of delivering greater performance at less cost and in less time while ... read more
Cold Chain Roundtable
Wednesday, March 27, 2013

MT: It seems that when American Thermal Instruments introduced our cloud-based temperature management system two years ago, we were the only company... read more
How Well Are You Adjusting to the New EU Post-Marketing Pharmacovigilance Requirements?
Monday, March 25, 2013

Quintiles

In July 2012, new legislation substantially amended the European Union’s pharmacovigilance (PV) requirements by strengthening and consolidating the PV... read more
Building a Sustainable API Supply Chain
Tuesday, January 29, 2013

Eli Lilly and Company

An active pharmaceutical ingredient (API) sourcing strategy is built upon a well-defined manufacturing process. The keys to the strategy involve using... read more

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Friday, May 25, 2012
Genotoxic Impurities Part 1: General Overview
This series of articles is intended to provide a general overview of the issues surrounding genotoxic impurities (GTIs) and their potential resolution... read more
Sunday, January 01, 2012
Forced Degradation to Develop Stability-indicating Methods
Forced Degradation (or stress testing) typically involves exposure of drug substances to heat, heat and humidity and light for solid-state studies. ... read more
Friday, July 01, 2011
Phase Change Materials, A Brief Comparison of Ice Packs, Salts, Paraffins, and Vegetable-derived Phase Change Materials
Passive processes for thermal energy storage have received a lot of attention in the past 25 years. These passive thermal energy storage materials ... read more
Tuesday, March 01, 2011
Regulatory Strategy for Long-Term Stability Conditions to Support Submission in Zone IV Countries
This paper provides a recommendation for selection of long-term stability conditions for submission of room temperature storage drug products in Zone ... read more
Monday, March 26, 2012
Accelerated Stability Assessment Program (ASAP): Using Science to Set Shelf Life
Among the challenges involved in developing acceptable commercial dosage forms for active pharmaceutical ingredients (API’s) is demonstrating adequate... read more

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Articles - Latest

Avoiding Pitfalls during Technology Transfer of Cell Culture Manufacturing Processes in the Pharmaceutical Industry – Mitigating Risk and Optimizing Performance

Insights Gained into the Identification, Qualification and Utilization of CRO Laboratories in Extractables and Leachables Studies

CMC Development Strategies for Small Pharma

How a Training Strategy Can Improve Clinical Trial Performance

Cold Chain Roundtable

How Well Are You Adjusting to the New EU Post-Marketing Pharmacovigilance Requirements?

Building a Sustainable API Supply Chain

All Articles - Most Viewed

Genotoxic Impurities Part 1: General Overview

Forced Degradation to Develop Stability-indicating Methods

Phase Change Materials, A Brief Comparison of Ice Packs, Salts, Paraffins, and Vegetable-derived Phase Change Materials

Regulatory Strategy for Long-Term Stability Conditions to Support Submission in Zone IV Countries

Accelerated Stability Assessment Program (ASAP): Using Science to Set Shelf Life

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