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

  • Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now
    Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now

    The Drug Supply Chain Security Act (DSCSA) will soon deliver another big impact to both pharmaceutical manufacturers/marketing authorization holders (MAHs) and distributors, with requirements for serialized product verification to comply with the next phase of requirements coming into effect Nov. 27, 2019.

  • Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations
    Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations

    Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use and to operate according to their design and functional specifications. In order to prove the requirements are met, qualification protocols have to be written and followed.

  • How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often
    How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

    The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.

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PHARMA ONLINE WHITE PAPERS

  • The Future Of BioManufacturing

    The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology.

  • Trends In Pharmaceutical Leak Tightness Testing

    Great confusion exists in the definition and application of leak tightness. That confusion is a result of improper leak-tightness design specifications. 

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INDUSTRY INSIGHTS

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PHARMA INDUSTRY EVENTS

Integrate 2018 July 23 - 25, 2018
Philadelphia, PA
Technical Report Writing July 23, 2018
Online Event, ON
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TRAINING COURSES

Cleanroom Microbiology – A Foundational Introduction July 24 - 24, 2018
1pm-2:30pm EDT, Online Training
Writing Effective 483 and Warning Letter Responses August 2 - 2, 2018
1pm-2:30pm EDT, Online Training
Communicating Beyond the Label: FDA’s Finalized Guidances & Updates August 8 - 8, 2018
1pm-2:30pm EDT, Online Training
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