Application of a Best Practice Approach Using Resonant Mass Measurement for Biotherapeutic Product Characterization.


:Characterizing and quantifying subvisible particles in protein drug products is critical to ensuring product quality. A variety of analytical methods are used to detect and make meaningful measurements of subvisible particles. Resonant mass measurement (RMM) is a novel technology that characterizes the subvisible particle content of samples on a particle-by-particle basis. The technology presents great promise in the study of therapeutic protein products. As an emerging tool in the biopharmaceutical field, the best practices and limitations of RMM for protein products have not been well established. One key challenge of particle analysis is producing robust and reliable data, with high precision and accuracy, for particle characterization. In this study, we develop a set of possible best practices for RMM using a model protein system. We test the effects of these practices on the repeatability and reproducibility of particle measurements. Additionally, we present the data collected under a rigorously controlled set of operating conditions at 3 collaborating sites as well as a summary of the resulting optimal practices. In employing these practices, we successfully obtained improved relative standard deviation values and achieved high reproducibility and repeatability in both sizing and concentration measurement results over a broad range of sample volumes.


J Pharm Sci


Krueger AB,Hadley J,Cheney PP,Markova N,Carpenter JF,Fradkin AH




Has Abstract


2019-05-01 00:00:00














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    authors: Dollo G,Le Corre P,Chollet M,Chevanne F,Bertault M,Burgot JL,Le Verge R

    更新日期:1999-09-01 00:00:00

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    abstract::Hyperthermia (HT)-dependent cisplatin (CDDP) release and tumor CDDP level increase after the administration of thermosensitive, large unilamellar vesicles (LUVs: LUV-1 and LUV-2) and a thermosensitive, small unilamellar vesicle (SUV: SUV-1) were examined in comparison with those following administration of a non-therm...

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    authors: Iga K,Hamaguchi N,Igari Y,Ogawa Y,Toguchi H,Shimamoto T

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    abstract::The oral dose metabolism of dilazep dihydrochloride [tetrahydro-1H-1,4-diazepine-1,4(5H)-dipropanol 3,4,5-trimethoxybenzoate] was examined in six hypertensive patients receiving a single oral dose of 600 mg of dilazep (3-3.8 mg/kg BW). Blood was collected at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 h after administratio...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Sambhi MP,Kannan R,Thananopavarn C,Ookhtens M,Gudenzi M

    更新日期:1989-04-01 00:00:00

  • Metal complexes of anhydrotetracycline. 1. A spectrometric study of the Cu(II) and Ni(II) complexes.

    abstract::Anhydrotetracycline (AHTC), one of the major toxic decomposition products of the antibiotic tetracycline, contains several potential binding sites to metal ions. The acidity constants of the ligand were calculated in aqueous medium (I = 0.1 M) at 25 and 37 degrees C. We found pKa1 = 3.23 +/- 0.08, pKa2 = 5.94 +/- 0.09...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: de Siqueira JM,Carvalho S,Paniago EB,Tosi L,Beraldo H

    更新日期:1994-03-01 00:00:00

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    abstract::Virtually all biological variables, including those affected by drugs, are subject to adaptive self regulation. In the description of the pharmacodynamics (PD) of drugs, it may be necessary to consider the endogenous control system (ECS) as an integral part of the PD. A PDECS model based on system analysis principles ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Veng-Pedersen P,Modi NB

    更新日期:1993-03-01 00:00:00

  • Kinetics and mechanism of the equilibrium reaction of triazolam in aqueous solution.

    abstract::The equilibrium kinetics of triazolam in aqueous solution was investigated in the pH range of 1-11 at body temperature. The quantitative study indicated that it forms equilibrium mixtures consisting of ring-opened and closed forms with the composition being dependent on pH. The equilibrium constants of the two species...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Konishi M,Hirai K,Mori Y

    更新日期:1982-12-01 00:00:00

  • Establishment of a Drug-Induced, Bile Acid-Dependent Hepatotoxicity Model Using HepaRG Cells.

    abstract::Bile acid (BA) retention within hepatocytes is an underlying mechanism of cholestatic drug-induced liver injury (DILI). We previously developed an assay using sandwich-cultured human hepatocytes (SCHHs) to evaluate drug-induced hepatocyte toxicity accompanying intracellular BA accumulation. However, due to shortcoming...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Susukida T,Sekine S,Nozaki M,Tokizono M,Oizumi K,Horie T,Ito K

    更新日期:2016-04-01 00:00:00

  • Synthesis and preliminary pharmacology of an internal standard for assay of neostigmine.

    abstract::The synthesis of the diethyl analog of neostigmine, its preliminary pharmacology, and its use as an internal standard for the GLC assay of neostigmine are described. Both the diethyl analog and neostigmine undergo thermal demethylation in the injection port. The column selected produced satisfactory resolution and sho...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Ward HE Jr,Freeman JJ,Sowell JW,Kosh JW

    更新日期:1981-04-01 00:00:00

  • Calorimetric determination of the heat of precipitation of pseudoephedrine racemic compound--its agreement with the heat of solution.

    abstract::The heat of precipitation of dl-pseudoephedrine was determined by direct calorimetry using a Tronac isoperibolic calorimeter. The precipitation of dl-pseudoephedrine was induced by mixing aqueous solutions of the two enantiomers, namely, d- and l-pseudoephedrine, directly in the calorimeter. The molar heat of precipit...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Pudipeddi M,Sokoloski TD,Duddu SP,Carstensen JT

    更新日期:1995-10-01 00:00:00

  • Progesterone retention by rat uterus I. Pharmacokinetics after uterine intraluminal instillation.

    abstract::Tritium-labeled progesterone was administered to mature female rats in the proestrous stage by three different routes, gastric intubation, subcutaneous injection, and uterine intraluminal instillation, to study the kinetics involved in the uptake and retention of radioactivity by the uterus and various other tissues. ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Fang SM,Lin CS,Lyon V

    更新日期:1977-12-01 00:00:00

  • Effect of time errors on infinity values obtained using Prony's method.

    abstract::The estimates of infinity values obtained using Prony's method are shown to be subject to significant error arising from small errors in the assigned sample times. The error of the estimate may be reduced by increasing the time interval between samples. ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Newburger J,Stavchansky S,Pearlman RS

    更新日期:1980-10-01 00:00:00

  • Micronization of anti-inflammatory drugs for pulmonary delivery by a controlled crystallization process.

    abstract::Jet-milling as the common way for micronization of drugs shows several disadvantages. Drug powder properties are decisive for pulmonary use because, besides a small particle size, a good deagglomeration behavior is required. In this study, several anti-inflammatory drugs [beclomethasone-17,21-dipropionate (BDP), betam...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Rasenack N,Steckel H,Müller BW

    更新日期:2003-01-01 00:00:00

  • Development of a Rational Design Space for Optimizing Mixing Conditions for Formation of Adhesive Mixtures for Dry-Powder Inhaler Formulations.

    abstract::The purpose of the present study was to develop guidance toward rational choice of blenders and processing conditions to make robust and high performing adhesive mixtures for dry-powder inhalers and to develop quantitative experimental approaches for optimizing the process. Mixing behavior of carrier (LH100) and Astra...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Sarkar S,Minatovicz B,Thalberg K,Chaudhuri B

    更新日期:2017-01-01 00:00:00

  • Quantitative flash-methylation analysis of phenobarbital.

    abstract::In phenobarbital measurement by GLC with the flash-methylation technique, using trimethylanilinium hydroxide as a methylating reagent, a small amount of water decomposed phenobarbital and interfered with the quantitative analysis. Thus, both the sample and the methylating reagent must be sufficiently dehydrated to att...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Kurata K,Takeuchi M,Yoshida K

    更新日期:1979-09-01 00:00:00

  • A Measurement and Modeling Study of Hair Partition of Neutral, Cationic, and Anionic Chemicals.

    abstract::Various neutral, cationic, and anionic chemicals contained in hair care products can be absorbed into hair fiber to modulate physicochemical properties such as color, strength, style, and volume. For environmental safety, there is also an interest in understanding hair absorption to wide chemical pollutants. There hav...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Li L,Yang S,Chen T,Han L,Lian G

    更新日期:2018-04-01 00:00:00

  • Evaluation of Transdermal Drug Permeation as Modulated by Lipoderm and Pluronic Lecithin Organogel.

    abstract::The transdermal delivery of 2 fluorescent probes with similar molecular weight but different lipophilicity, into and through the skin from 2 commercially available transdermal bases, pluronic lecithin organogel, and Lipoderm® has been evaluated. First, in vitro penetration of fluorescein sodium and fluorescein (free a...

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    authors: Zhang Q,Song Y,Page SW,Garg S

    更新日期:2018-02-01 00:00:00

  • Electronic monitoring of events within dynamic particulate beds: conductance and capacitance measurements.

    abstract::Methods for monitoring mechanical events occurring within particulate solids systems in a dynamic state are described. The electrical conductance and capacitance characteristics of such systems, as they relate to the degree of bed dilation or expansion, extent of interparticulate contact, and intensity of particle mot...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Rippie EG,Kriesel DC,Rettig H

    更新日期:1978-08-01 00:00:00

  • Development of a thermally responsive nanogel based on chitosan-poly(N-isopropylacrylamide-co-acrylamide) for paclitaxel delivery.

    abstract::A thermally responsive nanogel was developed through the radical polymerization based on chitosan (CTS) and N-isopropylacrylamide (NIPAAm) with acrylamide (AAm) blended to explore the possibility of increasing the volume phase transition temperature (VPTT). The thermally sensitive features of resultant nanogels were s...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Wang Y,Xu H,Wang J,Ge L,Zhu J

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  • Synthesis of tetracycline ring A analogs.

    abstract::Studies directed at the synthesis of tetracycline ring A analogs are described. 4-Carbethoxycyclohexane-1,3-dione was converted to the ethyl urethan dispiro[1,3-dioxolane-2,2'-cyclohexane-4',2"(1,3)-dioxolane]-1'-carbamic acid ethyl ester via the dispiro[1,3-dioxolane-2,2'-cyclohexane-4'-2"(1,3)-dioxolane]-1'-carboxyl...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Moskalyk RE,Mak AL,Chatten LG,Locock RA

    更新日期:1981-05-01 00:00:00

  • Metabolic profile of tripelennamine in humans.

    abstract::Volunteers were injected im with 100 mg of tripelennamine (pyribenzamine).HCl dissolved in saline. Timed urine was collected. Tripelennamine and its metabolites were identified by GC/MS. Amounts of free tripelennamine excreted in the 0-2-, 2-4-, 4-8-, 8-12-, and 12-24-h urine samples were found to be 0.30, 0.56, 0.17,...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Yeh SY

    更新日期:1991-09-01 00:00:00

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    abstract::The human immunodeficiency virus has infected millions of people and the epidemic continues to grow rapidly in some parts of the world. Antiretroviral (ARV) therapy has provided improved treatment and prolonged the life expectancy of patients. Moreover, there is growing interest in using ARVs to protect against new in...

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    authors: Kirtane AR,Langer R,Traverso G

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  • Development and optimization of self-nanoemulsifying drug delivery system with enhanced bioavailability by Box-Behnken design and desirability function.

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    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章


    authors: Marasini N,Yan YD,Poudel BK,Choi HG,Yong CS,Kim JO

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    abstract::Resveratrol trimethyl ether (trans-3,5,4'-trimethoxystilbene, RTE) is a naturally occurring and pharmacologically active resveratrol derivative. To evaluate its suitability as a drug candidate, a pharmacokinetic study was carried out in Sprague-Dawley rats with the emphasis to identify the impact of aqueous solubility...

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    abstract::The concept of cosolvent exclusion was developed by a group of Timasheff's laboratory in 1970-1990 and is currently used widely to explain the effects of a variety of cosolvents on the stability and solubility of macromolecules. Not surprisingly, these concepts have had substantial influence in the fields of formulati...

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    authors: Arakawa T,Gagnon P

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    pub_type: 杂志文章


    authors: Taylor P,Braddock PD,Ross S

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  • High-performance liquid chromatographic method for the determination of tiflamizole in plasma.

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    authors: Mauritz JM,Morrisby RS,Hutton RS,Legge CH,Kaminski CF

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    pub_type: 杂志文章


    authors: Segal R,Breuer A,Milo-Goldzweig I

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    abstract::Previous studies from this laboratory suggested that a solution model (Flory-Huggins equation) modified by a free volume model (Vrentas equation) could satisfactorily describe water absorption into an amorphous solid composed of a sugar or a polymer. This paper has extended the studies of single solutes to binary mixt...

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    pub_type: 杂志文章


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