EDITOR'S DESK

  • 60 Minutes To IND Success

    On 1/24/23, Daniela Drago, Ph.D. and Kati Abraham will join us for the discussion, IND Success: Navigate Through The Regulatory Gray, and I hope you do, too. We’ll talk through reasons for clinical holds, offer tips for avoiding and addressing them, and share best practices on ensuring smooth submissions on your journey from development to the clinic.

Big Bio Breeds Startup Leadership

Richard Francis’ arrival at Purespring in 2021 was indicative of a longer-term trend in the biopharma space that’s inciting a bit of a talent exodus from Big Pharma to emerging bio. While he's now returning to his big pharma generics roots, here's what he looked for in a startup leadership opportunity.

Snake Oil Or Slippery CEO?

Nader Pourhassan was just charged with a whole bunch of crimes. At the nucleus of the charges sits Pourhassan’s overzealous—and as it turns out, illegal—oversell of leronlimab, the monoclonal antibody he hyped as an HIV and COVID-19 therapeutic panacea when he was CEO at Cytodyn.

Inside The Altavant/Enzyvant Self-Made Merger

Prior to their merger, Enzyvant and Altavant didn’t have much in common beyond their suffix and their CEO. That CEO is Bill Symonds, Pharm.D., the architect of the merger whose history with the "vants" runs deep. Here, Dr. Symonds shares the company’s strategy and the implications of the combination. 

From Racecars To Regenerative Medicine

Find out what inspired a mechanical engineer, a U.S. Marine veteran, and a racecar driver to launch a regenerative medicine company manufacturing perinatal tissue allografts and get its products to market at breakneck speed.

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BIOPROCESSING WHITE PAPERS

  • Manufacturing Strategies For mRNA Vaccines And Therapeutics
    2/19/2021

    mRNA has emerged as a promising modality for a wide range of therapeutics and vaccines and could become the break-through technology of this century. This technology will not only revolutionize the field of vaccine development by allowing a rapid response to disease outbreaks, it will also help to address diseases of unmet medical need with gene therapy approaches or cancer treatments. Learn more with our white paper.

  • Spray-Dried Bevacizumab: Treating Non-Small Cell Lung Cancer
    10/14/2021

    Development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

  • How Dwell Volume And Extra-Column Volume Impact Method Transfer
    9/22/2022

    Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.

  • Ultrafiltration Devices And Plates Offer Higher-Throughput Options For Cloning And PCR Workflows
    9/13/2021

    Standard techniques often involve multiple purification steps, each associated with significant product losses, therefore requiring large amounts of starting DNA to guarantee sufficient vector and insert material to complete subsequent ligation and transformation steps. In this paper, we describe the use of these ultrafiltration devices in various steps of the cloning workflow that can provide a more streamlined process and compare them against traditional methods of subcloning PCR-generated fragments.

  • Expediting Early-Phase Development Of Small Molecules: An Integrated Approach
    11/1/2022

    Small molecule APIs and drug products are more complex and potent than ever. Explore key strategies for efficiently advancing small molecules from API to pre-clinical data and clinical supply.

BIOPROCESS ONLINE CONTENT COLLECTIONS

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Bioprocess Online brings the latest takes on both the progress and the pitfalls of continuous manufacturing adoption in biopharma. Check out our complete and current take on continuous manufacturing in biopharmaceutical environments, all in one package, from seven of the leading minds on the topic.

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