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Borrowing is good, but invention is best.
As someone who helped invent and patent several types of biomedical instrument, I feel a traitor for writing the following: our market has unmet need for fast, accurate analytic tools. While I can certainly see why some will resist or equivocate in response, this is absolutely an opportunity and not censure.
It’s not just that messenger RNA (mRNA) needs to be rid of genetic impurities like truncated transcripts or incorrect DNA template, or that wrapping it in lipid nanoparticle formulation for delivery creates more complex analytic challenges. Other recently created, small-molecule less celebrated drug formulations also had a need for new or more powerful analytic tools. Plazomicin (marketed as Zemdri), a novel aminoglycoside effective against gram negative bacteria, required novel modes for development and manufacturing, but it also benefited from a specialized analytic tool, the QMS plazomicin immunoassay (1), for measuring quantities in human plasma while treating complicated urinary tract infections, for which it was FDA approved.
As written elsewhere, there is now also an overarching business imperative to deliver products by continually breaking previous speed record barriers. Once the rewards for increasing patent lifetimes by being earlier to market became tangible, this has provided sustained business impetus to accelerate every aspect that could potentially slow deployment and delivery, hence parallel and redundant capacities and the investment in buildings, manufacturing equipment, and now analytic tools.
When married to increased drug novelty and rising complexity, requirement to have actionable data this hour, not this week, month, or quarter, further deepens this unmet need. In pharmaceutical analytics, this might well be just what the doctor ordered. Don’t get me wrong, I am delighted capillary electrophoresis has made a reappearance, and we’ve imported various stripes of particle size analysis from material sciences. But I keep a weather eye for novel approaches, most especially those incorporating audacious physical determinations. When readers send descriptions about good methods they’ve personally used, we’ll find a way to incorporate them in our coverage. That really should add intensity and drama to analytics, and a dash of new character!
1. C. H. Lias, Letter to Microgenics Corporation, FDA.gov, Nov. 19, 2018.
Vol. 35, No. 3
When referring to this article, please cite it as C. Spivey, “Characterizing the Unseen Drama of Analytics,” BioPharm International, 35(3) 2022.
Chris Spivey is the editorial director of BioPharm International.