Author Archives: Cheryl Scott

Partnerships in Immunotherapy for the Future of Cancer Treatment

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Immunotherapy seeks to harness the power of our human immune system to fight disease. In this rapidly evolving field, collaboration among different stakeholders is essential to bringing new treatments to market. Patient advocacy groups, researchers, hospitals, manufacturers, and government entities all are working together to translate promising new research into life-saving products. Types of immunotherapy include monoclonal antibodies (MAbs) and antibody derivatives, checkpoint inhibitors (immune-modulating proteins), cancer vaccines, T-cell therapies, and cytokines — so the approach involves a range of…

February 14, 2019

Biopharmaceutical Characterization,
Part 1: Biological Assays —
A Conference Report

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In late October 2018, KNect365 brought together more than 250 analytical specialists to discuss characterization of well-characterized biologics in Rockville, MD. Speakers from the US Food and Drug Administration joined experts from leading biopharmaceutical companies, service providers, and consultancies, including BPI editorial advisor Nadine Ritter (president and analytical advisor of Global Biotech Experts). She began the final day moderating a special town-hall session where audience members could pose their regulatory questions to a panel of FDA reviewers, and she ended…

December 18, 2018

November From the Editor

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The word innovation carries with it connotations of both newness and change. Funny thing about that: Changing conditions require adaptation and originality in response to them — which often causes more change that will in turn require further innovation in response. In an industry based on science, this can (and should) be a neverending cycle either of playing catch-up — or of continually pushing the envelope. We hear a lot of talk about innovation in the biopharmaceutical industry these days.…

December 14, 2018

Rolling with the ‘Tides: Elucidating the Role of Peptides and Oligonucleotides in the Biopharmaceutical Industry

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In earlier issues of BPI we published a few “Elucidation†closers that we called “Defining Moments.†Since then, we have tried to distinguish key confusable terms from one another. Those presented (and sometimes “elucidatedâ€) have been analytical and bioanalytical, spectroscopy and spectrometry, and biosimilars and biobetters. They are just a few of the many confusable terms in the biopharmaceutical industry. For example, when someone says “drug delivery,†a formulator will think of a syringe or transdermal patch, but a logistics…

December 14, 2018

Partnerships in Immunotherapy: Working Together to Take Cancer Treatment to the Next Level

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Biopharmaceuticals are a particularly complex expression of medicine — and immunotherapies perhaps even more so. As treatments, these products themselves often also need “partners†of a kind: e.g., radiation/radiotherapies, traditional MAbs, and chemotherapies. Just as this field of endeavor requires the input and expertise of many different disciplines — from medical researchers to process engineers, clinicians to business leaders, and market experts to policy makers — this discussion of the topic of partnerships in immunotherapy brings together different experts in…

November 27, 2018

Inactivation of Enveloped Viruses: Seeking Alternatives to a Problematic Surfactant

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Triton X-100 detergent makes an interesting case study in bioprocess sustainability strategy. Also known as octylphenol ethoxylate (OPE), this nonionic surfactant has many uses in biopharmaceutical research and development. Among other laboratory applications, it is used to lyse cells and DNA in research, to solubilize membrane proteins and decellularize animal-derived tissues, to reduce the surface tension of aqueous solutions during immunostaining, and to remove sodium dodecyl sulfate (SDS) from polyacrylamide gel electrophoresis (PAGE) gels for analysis. It also serves as…

November 9, 2018

Trends in Chemistry, Manufacturing, and Controls: Next-Generation Technologies and Product Modalities

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New technologies bring new regulatory challenges. The biopharmaceutical industry must be cautious in its implementation of new scientific ideas and technology platforms — no matter how promising those might be. Regulators will look skeptically on any claim that isn’t backed up by good data, and with no solid history of successful use to build on, a company must have all the answers itself. How do compliance professionals anticipate what kinds of questions reviewers will ask when the time comes —…

September 25, 2018

Science Guiding Technology: Cell Line Development and Engineering 2018

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Cell line development engineers in the biopharmaceutical industry juggle several, sometimes contradictory priorities. They must present their bioprocessing colleagues with a master cell line that can express a reproducibly high-quality protein product at titers and growth concentrations that will be high enough for manufacturing efficiency — and without those parameters degrading over time. Performing the first step in every bioprocess, these scientists must consider their own budgetary concerns and efficiencies while facing regulatory scrutiny under the 21st-century risk-management paradigm. In…

September 19, 2018

September 2018 From the Editor

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Magazine editors live in a strange warped time frame. We put the finishing touches on this very September issue in mid-August, having begun working with the materials a month before that. Meanwhile, we’re in talks with authors and companies who will be contributing to the pages of our October and November–December issues and inserts. Anne is working already to acquire manuscripts for the early issues of 2019. When it comes to eBooks, however, we actually put them together during the…

September 15, 2018

June From the Editor

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It surprises some folks in the BPI community to learn that I’m a journalist by training, boasting a mere bachelor of arts degree in journalism despite my high-fallutin’ technical editor title. I was originally trained in Associated Press (AP) style by a veteran newsman who spent many years working for AP’s main competitor, United Press International (UPI). When I first started on BioPharm back in 1996, I had to get up to speed quickly on the stylebooks of Chicago and…

June 20, 2018