FROM THE EDITOR

What Is the Industry Underestimating About An ADC Supply Chain? – Part 2

In this article, Dan Bell, vice president of regulatory compliance and technical affairs for Marken, discusses regulatory challenges, and both he and Nathan Ihle, Ph.D., VP of CMC Strategy and Management at Seattle Genetics, offer best practices to apply when planning your ADC supply chain.

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PHARMA MANUFACTURING INSIGHTS

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    This patented single-pass technology is an opportunity to simplify current TFF processes. It eliminates the conventional TFF recirculation loop and allows product to be concentrated in a single pump pass by utilizing a proprietary flow path and flow ratio control.

  • Staying On Top Of Microbes: Smarter Testing Technology For Labs Of The Future
    Staying On Top Of Microbes: Smarter Testing Technology For Labs Of The Future

    Over the past decade, drug and medical device manufacturers have become leaner and more stream-lined. Given the current market pressures, companies are looking for more ways to improve their bottom-line.

  • To CBT Or Not To CBT…It Shouldn’t Be A Question
    To CBT Or Not To CBT…It Shouldn’t Be A Question

    Recently, a colleague sent me a question about whether performance assessments as part of training – verification of a trainee’s ability to perform a task in accordance with predefined criteria – were an industry standard. 

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    Purification Of Stevioside And Rebaudioside-A Using An Advanced Flash And Preparative LC System

    Stevioside and Rebaudioside-A are major low-calorie diterpene steviol glycosides found in the leaves of S. rebaudiana and used as a sweetener in food and beverages. These compounds range in sweetness level from 250 to 450 times sweeter than sugar. They are widely used as natural sweeteners for diabetic patients.

  • Cold Chain Passive Packaging Savings Through Reuse
    Cold Chain Passive Packaging Savings Through Reuse

    In today’s marketplace, biopharmaceutical companies are seeking improvements that lead to reductions in overall supply chain costs. With the ever increasing dimensional weight pricing, companies are going to be looking even more closely at cost saving supply chain ideas. When it comes to the packaging solutions used to ship temperature-sensitive materials, biopharmaceutical companies are considering the implementataion of reusable packaging programs.

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PHARMA CONTRIBUTING EDITORS

  • Leadership Lessons From 23andMe’s Jump Into Drug Discovery
    Leadership Lessons From 23andMe’s Jump Into Drug Discovery

    23andMe has been the center of attention quite a bit recently — not only because of its high profile partnerships with Pfizer and Genentech, but also because of the recent FDA approval of its carrier test for Bloom Syndrome. However, perhaps the biggest news for the company as of late was the announcement it is jumping into the drug discovery space.

  • Will China Ever See Its Own Blockbuster Drug?
    Will China Ever See Its Own Blockbuster Drug?

    It’s no secret that China is trying to become an attractive destination for companies looking to hold clinical trials and develop and manufacture drugs overseas. However, I’m also curious about what we can and should expect from the country in terms of innovation — especially when it comes to developing its own high profile drug.

  • FDA News Roundup: Novo Nordisk, AstraZeneca, Merck, And More
    FDA News Roundup: Novo Nordisk, AstraZeneca, Merck, And More

    What FDA decisions did you miss this week?

  • Where Did The Biobetters Buzz Go?
    Where Did The Biobetters Buzz Go?

    The past few weeks, it seems the word on everyone’s tongue — including my own — has been biosimilars. Since the approval of Novartis’ Zarzio in the U.S., there’s been a lot of discussion and speculation about how this important approval will affect current blockbusters on the market and who will enter the space next. But I’m left with another question: What happened to the buzz over biobetters?

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    Nilfisk CFM is leading the industry in manufacturing the safest, most powerful potent compound vacuums, HEPA vacuums, and ULPA vacuums available. Our vacuum solutions range from portable, intermittent-duty models for general cleaning to continuous-duty models for process-integrated applications and central vacuum systems.

  • PTI Packaging and Inspection Systems
    PTI Packaging and Inspection Systems

    Packaging Technologies & Inspection (PTI) is a leading manufacturer of inspection technologies for the pharmaceutical industry that are non-destructive, non-invasive, and require no sample preparation. Recognized as a thought leader in new delivery systems for leak detection, seal, package, and container integrity testing, PTI has set the standard for inspection systems that provide repeatable, reliable results. | Non-destructive package leak testing | Package integrity testing | Micro leak testing | Pouch seal inspection | Seal quality analysis |Blister package leak detection | Blister package seal integrity testing | Seal integrity testing | Package testing & inspection services | Leak testing empty bottles | Leak testing empty containers | Micro leak testing of vials | Micro leak testing of ampoules

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