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Publication following thorough peer review has been one the essential drivers of scientific progress. While the emergence of open access journals has spread knowledge to a wider audience, a few publishers have started to exploit the model of being specifically paid by authors. They have published so-called predatory journals that have sacrificed scientific scrutiny in favor of revenue. Papers in such journals may bear illegitimate conclusions and thus hamper scientific progress. Here, we did not only explain predatory journals in general, we also elaborated on an example and thereby demonstrated how exactly these journals may deviate from scientific standards. Namely, a manufacturer of bacterial endotoxin tests published in a potentially predatory journal and neglected relevant literature, ill-referenced other papers and made use of judgmental, non-scientific language. Apparently, said manufacturer aimed to shed doubt in recombinant DNA technology (here recombinant Factor C) for bacterial endotoxin testing and, thus, restrict its competitors’ access to this market. In turn, this may prevent the development of more accurate, reliable, rapid and affordable bacterial endotoxin tests und in turn hamper progress in pharmaceutical development and manufacturing.

The article “Scientific Studies and Interpretation” was published as a Guest Editorial in Vol. 74, No. 5, September–October 2020 of the PDA Journal of Pharmaceutical Science and Technology ( PDA-JPST ). This aforementioned article discusses the use of recombinant reagents for bacterial

Testing of parenteral pharmaceuticals and medical devices for pyrogens (fever-inducing substances) is critical to patient safety. The original rabbit pyrogen test has largely been replaced by different bacterial endotoxin tests based on Limulus amebocyte lysate (LAL), sourced from the blood equivalent of horseshoe crabs after comparative studies to the rabbit pyrogen test. Since 2004 a bacterial endotoxin test based on recombinant factor C (rFC), the endotoxin sensor protein inside of LAL, has been used as an animal-free alternative to LAL. Likewise, numerous studies compared LAL and rFC. Here we describe the history of pyrogen and bacterial endotoxin testing and summarize the evidence presented by those studies. We demonstrate that rFC and LAL are equivalent and comparable.

Doses for standing sedation allowing for various procedures in otherwise inaccessible, untrained captive African elephant bulls are presented. Thirty-three standing sedations were performed in 12 males aged 8–30 years (one to four sedations per animal). Each bull received a combination of 0.009 ± 0.002 mg/kg medetomidine and 0.03 ± 0.007 mg/kg butorphanol. Full sedation was reached on average 25.5 min after injection. The addition of hyaluronidase (1000–2000 IU) significantly reduced time to full sedation to 16.5 min (paired t test, P = 0.024). Reversal was induced with intramuscular atipamezole 0.008 (±0.002) and naltrexone 0.035 (±0.015) mg/kg. Recovery took on average 7 min (3–18 min). The medetomidine/butorphanol combination provided safe standing sedation for smaller procedures.