Profiling of medium chain glycerides used in pharmaceutical formulation development by reversed-phase HPLC

Fliszar, Kyle A.; Wuelfing, W. Peter; Li, Zhong; Reed, Robert A.

doi:10.1016/j.jpba.2005.08.024

Cited by 17 publications

(11 citation statements)

References 12 publications

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“…The residual caprylic acid in the supernatants or eluate pools was quantified by RP‐HPLC with a Waters Symmetry® C18 column (150 mm × 4.6 mm, 3.5 µm, WAT 200632). The running protocol, a linear gradient of 30–80% acetonitrile in 0.1% phosphoric acid over 25 min, is a modified Fliszar method (Fliszar et al, 2006). Injection volume was 20 µL and the flow rate was 1 mL/min.…”

Section: Methodsmentioning

confidence: 99%

Caprylic acid precipitation method for impurity reduction: An alternative to conventional chromatography for monoclonal antibody purification

Brodsky

Zhang

Yigzaw

et al. 2012

Biotech & Bioengineering

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We report the use of caprylic acid based impurity precipitation as (1) an alternative method to polishing chromatography techniques commonly used for monoclonal antibody purification and (2) an impurity reduction step prior to harvesting the bioreactor. This impurity reduction method was tested with protein A purified antibodies and with cell culture fluid. First, the operational parameters influencing precipitation of host cell proteins and high molecular weight aggregate in protein A pools were investigated. When used as a polishing step, the primary factor affecting purification and yield was determined to be pH. Caprylic acid precipitation was comparable to polishing IEX chromatography in reducing host cell protein and aggregate levels. A virus reduction study showed complete clearance of a model retrovirus during caprylic acid precipitation of protein A purified antibody. Caprylic acid mediated impurity precipitation in cell culture showed that the impurity clearance was generally insensitive to pH and caprylic acid concentration whereas yield was a function of caprylic acid concentration. Protein A purification of caprylic acid precipitated cell culture fluid generated less turbid product pool with reduced levels of host cell proteins and high molecular weight aggregate. The results of this study show caprylic acid precipitation to be an effective purification method that can be incorporated into a production facility with minimal cost as it utilizes existing tanks and process flow. Eliminating flow through chromatography polishing step can provide process intensification by avoiding the process tank volume constraints for high titer processes.

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Section: Methodsmentioning

confidence: 99%

Caprylic acid precipitation method for impurity reduction: An alternative to conventional chromatography for monoclonal antibody purification

Brodsky

Zhang

Yigzaw

et al. 2012

Biotech & Bioengineering

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“…Extensive research has been carried out using high-performance liquid chromatography (HPLC) [23,24] and HPLC coupled with silver chromatography (Ag–HPLC) [25]. Separation of mono- and diglycerides is also possible by HPLC–gel permeation chromatography [26].…”

Section: Introductionmentioning

confidence: 99%

Enzymatic Determination of Diglyceride Using an Iridium Nano-Particle Based Single Use, Disposable Biosensor

Hsu

Bartling

Wang

et al. 2010

Sensors

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A single use, disposable iridium-nano particle contained biosensor had been developed for the determination of diglyceride (DG). In this study hydrogen peroxide, formed through the enzymatic breakdown of DG via lipase, glycerol kinase and glycerol 3-phosphate oxidase, was electrochemically oxidized at an applied potential of +0.5 V versus the Ag/AgCl reference electrode. The oxidation current was then used to quantify the diglyceride concentration. Optimum enzyme concentrations and the surfactant loading used were established for successful sensor response. Good linear performance was observed over a DG concentration range of 0 to 25 μM in phosphate buffer and bovine serum media.

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“…Similar material is also supplied under different trade names by different vendors, such as Imwitor by Sasol Corp. (Houston, TX). Variations in acyl glycerol composition have been reported between the two products 21. Although Imwitor was not tested in our study, it is reasonable to expect that a similar interaction between TPV and the 1,3‐diacyl glycerols present in these excipients will occur when using the same SEDDS vehicle described in this study.…”

Section: Resultsmentioning

confidence: 65%

Drug–Excipient Complexation in Lipid Based Delivery Systems: An Investigation of the Tipranavir-1,3-Dioctanolyglycerol Complex

Chen

Dudhedia

Wang

et al. 2009

Journal of Pharmaceutical Sciences

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Profiling of medium chain glycerides used in pharmaceutical formulation development by reversed-phase HPLC

Cited by 17 publications

References 12 publications

Caprylic acid precipitation method for impurity reduction: An alternative to conventional chromatography for monoclonal antibody purification

Caprylic acid precipitation method for impurity reduction: An alternative to conventional chromatography for monoclonal antibody purification

Enzymatic Determination of Diglyceride Using an Iridium Nano-Particle Based Single Use, Disposable Biosensor

Drug–Excipient Complexation in Lipid Based Delivery Systems: An Investigation of the Tipranavir-1,3-Dioctanolyglycerol Complex

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