EDITORS' DESK

  • New U.S And Canadian Facilities Boosting Biologics Capacity
    New U.S And Canadian Facilities Boosting Biologics Capacity

    Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

A Glimpse Into Thailand’s Ongoing Life Sciences Transformation

During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.

What Thailand Revealed About U.S. Pharma R&D

A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

Top 5 Biosimilar Developments Of 2016

In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

Are You The Future of Pharmaceutical Development?

Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.

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GUEST CONTRIBUTORS

  • Military Tool For Vulnerability Assessment: The CARVER + Shock Technique

    CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.

  • Techniques For Risk-Based Validation Using ASTM E2500

    ASTM standard E2500, Specification, Design, and Verification of Pharma and Biopharma Manufacturing Systems and Equipment, elevates risk-based validation as a critical aspect of GMP manufacturing. This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective

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PHARMA ONLINE WHITE PAPERS

  • Efficiencies In Powder Dispersion For Manufacturers

    Uniformly dispersing powders into a liquid batch in a practical amount of time is a common problem for F&B manufacturers. This white paper explores five tips for dispersing powders more efficiently.

  • Density And Refractive Index Measurement In Pharmaceutical Glycerin Production Density measurement, and subsequent conversion into concentration values, is used for quality and process control throughout the whole purification process, i.e. controls of glycerin contents or glycerin purity. Additionally, the refractive index for pharmaceutical glycerin is demanded by Pharmacopoeia, and gives more detailed information. Submitted by Anton Paar
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FREE CLEANING VALIDATION E-BOOK

Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.

INDUSTRY INSIGHTS

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TRAINING COURSES

Adverse Event Reporting: Avoiding Common Pitfalls June 11 - 11, 2019
1pm-2:30pm EDT, Online Training
Effective Batch Record Review – Getting It Right The First Time June 18 - 18, 2019
RECORDING, Online Training
21 CFR Part 11: Understanding the ERES Regulation for Compliance Success June 19 - 19, 2019
1pm-2:30pm EDT, Online Training
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