Recombinant Factor C (rFC) is non-animal-derived reagent used to detect bacterial endotoxins in pharmaceutical products. Despite the fact that the reagent was first commercially available nearly 15 years ago, the broad use of rFC in pharmaceutical industry has long been lagging, presumably due to historical single-source supplier concerns and the lack of inclusion in worldwide pharmacopeias. Commercial rFC reagents are now available from multiple manufacturers, thus single sourcing is no longer an issue. We report here the successful validation of several pharmaceutical products by an end-point florescence-based endotoxin method using the rFC reagent. The method is equivalent or superior to the compendia bacterial endotoxins test method. Based on the comparability data and extenuating circumstances, the incorporation of the end point fluorescence technique and rFC reagent in global compendia bacterial endotoxins test chapters is desired and warranted. Public health has been protected for over 30 years with the use of a purified blood product of the horseshoe crab, limulus amebocyte lysate. More recently, this blood product can be produced in biotech manufacturing processes, which reduces potential impacts to the horseshoe crab and related species dependent upon the crab, for example, migrating shorebirds. The pharmaceutical industry has been slow to adopt the use of this reagent, Recombinant Factor C (rFC), for various reasons. We evaluated the use of rFC across many pharmaceutical products, and in other feasibility demonstration experiments, and found rFC to be a suitable alternative to the animal-derived limulus amebocyte lysate. Incorporation of rFC and its analytical method into national testing standards would provide an equivalent or better test while continuing to maintain patient safety for those who depend on medicines and while securing pharmaceutical supply chains. In addition, widespread use of this method would benefit existing animal conservation efforts.
Bacterial endotoxin is a Gram-negative bacterial cell wall component that is harmful to humans at threshold concentrations, and it is not expected to be in aseptically-produced pharmaceutical medicines. It has been suggested that endotoxin cannot be detected over time in certain biopharmaceutical drug product formulations containing citrate, phosphate, and polysorbate components via an unknown masking mechanism. We have generated and present data here that indicate that endotoxin can be recovered in a variety of matrices, and under various experimental conditions.
25I n the April 2000 issue, Training Magazine raised complaints about instructional systems design (ISD) to a new level of our consciousness. They outlined the complaints: • ISD is too slow and clumsy to meet today's training challenges. Yes, ISD's pace is glacial in an Internet world demanding speed and adapting to constant change. Statements such as "the analysis itself will take a month and a half" make our clients and critics lose patience. But ISD can move quickly, deliberately, and systematically. Our approach is very visible, predictable, repeatable, and systematic. It is "lean."• There's no "there" in ISD. This questions whether there is an instructional "technology" for training in the first place. Too often people have learned from "stuff" that was created in processes that didn't follow the ISD-ADDIE model. We disagree.• Used as directed, ISD produces bad solutions. Yes, too often ISD begins without a business purpose in mind, and therefore can be applied poorly. Or it over-reacts to a fraud, such as designing for "learning styles" (a concept easy to like but thoroughly debunked by actual research), resulting in wasted effort and time. Or it breaks the learning process into ridiculously tiny increments and forces unnecessary exercises and assessments.• It clings to the wrong world view. Training Magazine's article suggests that ISD arrogantly assumes a "stupid learner" who needs constant handholding to learn anything, and instruction designed to the lowest common denominator. But that's if the "product" was intended to teach to the lowest common denominator, either because that's where the bulk of the learners were and/or the enterprise simply couldn't afford multiple versions, or the ISDer didn't know how to chunk it and create multiple entry points in the learning process, or the deployment method wouldn't allow for that.While we disagree with most of these blanket statements, we know there is some truth in these complaints for many of the ISD approaches we've seen in action, or seen in the results thereof. Those complaints in "the ATTACK on ISD" resonated with us too, because we've heard them before.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.