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.

More From Our Editors

GUEST CONTRIBUTORS

  • 4 Trends In Recent FDA Warning Letters To OTC Drugmakers — And How To Avoid Them
    4 Trends In Recent FDA Warning Letters To OTC Drugmakers — And How To Avoid Them

    A recent flurry of warning letters issued to manufacturers of over-the-counter (OTC) drug and health products has revealed similar deficiencies related to current good manufacturing practice (GMP) and quality management expectations.

  • 4 (More) Microbiological Root Cause Analyses Lessons From Sherlock Holmes
    4 (More) Microbiological Root Cause Analyses Lessons From Sherlock Holmes

    Bias can take many forms and is often not easily recognized by an investigator. Sherlock Holmes was keenly aware of bias' potential impacts and so did not allow bias generated through speculation, random hypothesis, or previous experience to determine or redirect the course of his investigations. Applying more of Holmes’ famous observations and investigative principles can uncover hidden bias and greatly increase an investigator’s chance of finding that elusive definitive root cause.

  • Cutting Packaging Costs: What Life Sciences Can Learn From Consumer Packaged Goods
    Cutting Packaging Costs: What Life Sciences Can Learn From Consumer Packaged Goods

    Industries can (and should) learn from one another. As the life sciences market continues to become more competitive and social pressure to reduce healthcare costs increases, consumer packaged goods (CPG) approaches and strategies to cut packaging costs can be applied to life sciences to achieve these objectives. 

  • Equipment Change Control For GMP Production Facilities — Proving It All Works

    The first article in this two-part series outlined the six primary stages of equipment change control and discussed the first two stages: (1) determining the equipment utility/IT requirements and (2) pre-installation assessment, utility evaluation, and remediation. This article describes the final four stages of this process: (3) evaluating the impact of new equipment installation on previously validated utilities, (4) executing validations for new equipment, (5) review of equipment turn-over packages and validation reports, and (6) performing change control effectiveness checks.

  • 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design

    Often, the last thing on the minds of drug development teams working is the human factors engineering (HFE) performance of the drug delivery devices that will ultimately deliver their innovative medications to patients. Yet, such an oversight can cause major delays in delivering these new medications to market. 

More From Guest Contributors

PHARMA ONLINE WHITE PAPERS

  • Mixing & Blending Equipment: Give Renting A Try

    Unanticipated demand spikes, product line expansions and process improvements generally spell good business. But they may also spell the sudden need for processing equipment. By Charles Ross and Son Company

  • Function Integration Saves Time All Round

    When electrical and pneumatic subsystems are separated, all the phases of building even relatively simple systems can take a lot of time. By Nigel Dawson

More Pharma Onine White Papers

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

More Industry Insights

PHARMA INDUSTRY EVENTS

Global Heart Congress July 22 - 23, 2019
Golden Wall Center
Microbiome Movement - Oncology Response Summit July 22 - 24, 2019
Revere Hotel Boston Common, Boston, MA
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TRAINING COURSES

FDA's eCTD Ad-Promo Guidance Is Finalized: Are You Ready? August 7 - 7, 2019
1pm-2:30pm EDT, Online Training
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error August 8 - 8, 2019
1pm-2:30pm EDT, Online Training
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