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

  • Improving Training In Biopharmaceutical Manufacturing
    Improving Training In Biopharmaceutical Manufacturing

    Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.

  • Are You Asking Too Much From Your Filler?
    Are You Asking Too Much From Your Filler?

    The core mission of the pharmaceutical industry is to manufacture products for patients to cure them, vaccinate them, or alleviate a symptom, often by manufacturing a liquid injectable or an oral solid, among other therapies. In this article, we will focus on the aseptic injectable, from a general standpoint, to see what we are doing with our aseptic filling systems and why.

  • When To Use A Fishbone Diagram…And Why You Should Do It More Often Than You Think
    When To Use A Fishbone Diagram…And Why You Should Do It More Often Than You Think

    The previous article in our "Identifying And Resolving Errors, Defects, And Problems Within Your Organization" series focused on identifying manufacturing trends so you can know when to act. This one discusses what needs to happen when a defect or nonconformance is detected and needs to be investigated, explaining one of the most broadly applicable and durable root cause analysis tools: the fishbone diagram.

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PHARMA ONLINE WHITE PAPERS

  • Microemulsion Capsule Technology To Optimize Drug Delivery The basic concept of self-emulsifying drug delivery systems (DDS) is to deliver the drug in solution to the site of absorption or to protect the drug from being substantially metabolized in the gastro-intestinal tract or the gut membrane. Submitted by Capsugel
  • Achieving Faster Formulation Of Solid Oral Dosage Forms

    The pharma industry is increasingly looking for approaches that shorten drug development timelines and save on cost, especially virtual biotech companies who rely heavily on key milestone payments. 

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INDUSTRY INSIGHTS

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TRAINING COURSES

CRO Oversight Post ICH GCP E6 (R2) Addendum October 24 - 24, 2018
1pm-2:30pm EDT, Online Training
Stability Programs - Key Factors in Meeting FDA/ICH Expectations October 25 - 25, 2018
1pm-2:30pm EST, Online Training
Medical Devices - Effective Complaint Handling and Management November 2 - 2, 2018
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The Investigational New Drug (IND) Submission – Tips to Win the First Time November 2 - 2, 2018
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Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 5 - 5, 2018
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