• UPS Pain In The Chain Survey: Pharma Makes Gains In Compliance, Partnerships
    UPS Pain In The Chain Survey: Pharma Makes Gains In Compliance, Partnerships

    UPS' Pain in the Chain survey is one of the best ways to understand where life science companies stand on the issues making logistics a headache and keeping executives up at night. Since 2008, the survey of healthcare and life science supply chain professionals has attempted to determine the needs of these companies.

Is The Pharma Industry Really An Enemy?

I consider myself to be a fan of the pharmaceutical industry. This is not simply because I write for a media group that covers the pharma industry. I feel like I was a fan even before taking on my current job. It may have started a few years ago when an ailment of old age (I’m 52) began to inconvenience me and disrupt my sleep. One little white pill taken once per day has now relieved me of that issue. So, while there are many industries that bring happiness and efficiencies into my life, only one of those industries has the potential to save the lives of patients with life threatening illnesses, and ease the suffering of others. That is the pharmaceutical industry.

WIB Profile: Mergers, Funding, & Financing Continue To Surge In Biotech

Faith Charles is a Corporate Securities and Transactions Partner and Chair of Life Sciences for the law firm Thompson Hine LLP. To gain some insight into the legal challenges that exist for small life science companies, I asked attorney Charles to be the next participant in my Women in Bio profile series.

Lilly Banks On Equity Investing To Grow Pipeline

Lilly continues to partner with academic institutions and biotech companies, and more recently has been entering into a greater number of collaborations with other Big Pharma companies. But one area where the company has devoted significant resources, and which is certainly a big part of Lilly’s partnering strategy, is equity investing.   

Are Absolute Cell Counts Essential In Drug Discovery?

While absolute cell counts have been a part of diagnosis for a long time, what is new are absolute count relevance to drug discovery and development. 

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The First Step To Navigating Your Combination Product’s Regulatory Pathway: PMOA

The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.

Scalable Automation For Drug Delivery Devices

Today’s medical device and pharma industry assembly concepts can be complex. Here, Bill Welch, chief technology officer, Phillips-Medisize, outlines why, therefore, the company provides a comprehensive assembly concept, tailored to customers’ needs. Scalability begins with early DFM (design for manufacture) / DFA (design for assembly) philosophy integrated into the product development process.

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  • A cGMP Compatible Purification Process For Positron Emission Tomography (PET) Imaging

    We developed a cGMP compatible purification process using the NGC Discover™ 10 Pro Chromatography System for preclinical development and subsequent clinical development of a next generation positron emission tomography (PET) imaging agent.

  • Modes Of Controlling Charge Variant Distribution In MAb Production By Upstream And Downstream Process Parameters

    The characteristics of a biological drug, for example, charge variant profile, are determined to a large extent by the upstream expression system and conditions, but can also be influenced by the purification process. Charge variant distribution is a critical quality attribute for MAbs and is therefore of interest to monitor and control during the production process.

  • Purification Of Interferon α - A Process Development Study

    Biosimilar production is not required to follow the same process as the originator, encouraging the choice of new and potentially more efficient manufacturing steps during process development. Furthermore, modern methods such as high-throughput process development (HTPD) allow faster and more thorough screening, optimization, and characterization. This simplifies the selection of better methods and helps establish running conditions that assure a robust manufacturing process.

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Lyophilization Week May 9 - 12, 2016
Bethesda, MD
Lyophilization - An Introduction to the Scientific Principles May 10, 2016
1pm-2:30pm EDT, Online Training
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