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PDA Journal of Pharmaceutical Science and Technology

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https://www.readbyqxmd.com/read/28733334/application-of-recombinant-factor-c-reagent-for-the-detection-of-bacterial-endotoxins-in-pharmaceutical-products
#1
Jay S Bolden, Kelly R Smith
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...
July 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28733333/method-development-for-container-closure-integrity-evaluation-via-headspace-gas-ingress-by-using-frequency-modulation-spectroscopy
#2
Ken G Victor, Lauren Levac, Michael Timmins, James Veale
USP <1207.1> Section 3.5 states that "A deterministic leak test method having the ability to detect leaks at the product's maximum allowable leakage limit is preferred when establishing the inherent integrity of a container-closure system." Ideally, container closure integrity (CCI) of parenteral packaging would be evaluated by measuring a physical property that is sensitive to the presence of any package defect that breaches package integrity by increasing its leakage above its maximum allowable leakage limit (MALL)...
July 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28733332/demonstration-of-the-maintaining-the-validated-state-of-a-system-used-to-generate-water-for-injection-by-thermocompression
#3
Alberto Leyva, Iriac Bisquet, Tania de la Cruz, Leoner Del Arco, Joel Ríos, Rodolfo Valdés, Sonny Robles, Fabian Ugarte, Manuel Montané
Water for injection is used in multiple applications in Biopharmaceutical industry. Regarding this, several methods have been use to generate water with this high quality. Within them, the thermos-compression distillation method has been widely employed. Though, reports on the maintenance of the qualification and validation status of thermo-compression systems used for water for injection generation are non-existent in the scientific literature. Therefore, this paper sought to give evidences on continue process verification of a system used for water for injection generation during two years analyzing the level of conductivity, nitrate, total organic carbon (TOC), endotoxins and microbiology in 1284 water samples...
July 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28624777/a-novel-lack-of-fit-assessment-as-a-system-suitability-test-for-potency-assays
#4
Ruojia Li, Weiguo Cai, Marcel Zocher
Bioassay data analysis is used to determine the potency of protein therapeutics. To properly determine potency, the experimental data need to be fitted to a model that adequately describes the observed dose-response relationship. Typical models include 4-parameter logistic curve fits (Healy (5)), 5-parameter logistic curve fits (Prentice (6)) or parallel line analysis (Finney (7)). Lack-of-Fit (LOF) assessment can be used as a measure of potency assay system suitability to ensure appropriate closeness of the chosen model fit to the experimental data...
June 16, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28624776/mold-control-and-detection-in-biological-drug-substance-manufacturing-facilities-an-industry-perspective
#5
Anita Bawa, Sophia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Francisco Leira, Kim McFarland, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis, David Baine, Derek Willison-Parry
The biopharmaceutical industry produces non-sterile and/or low-bioburden intermediates and bulk biologics (i.e. Drug Substances) using bioburden controlled processes in accordance to Q7A and Annex 2. In many cases, single mold isolation events have received a high level of scrutiny; the goal of this paper is to challenge this paradigm and provide the rationale for an enhanced control approach that focuses on trending of mold species as microbial indicators rather than on single isolation events. Molds, can also be part (in much lower numbers) of the normal microbial population of a biologics manufacturing facility and, therefore, mold isolation is not an unexpected event in non-aseptic processing environments...
June 16, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28624775/complexing-agents-and-ph-influence-on-chemical-durability-of-type-i-moulded-glass-containers
#6
Alberto Biavati, Michele Poncini, Arianna Ferrarini, Nicola Favaro, Martina Scarpa, Marta Vallotto
Among the factors that affect the glass surface chemical durability, pH and complexing agents presence in aqueous solution have the main role (1). Glass surface attack can be also related to the delamination issue with glass particles appearance in the pharmaceutical preparation. A few methods to check for glass containers delamination propensity and some control guidelines have been proposed (2,3). The present study emphasizes the possible synergy between a few complexing agents with pH on the borosilicate glass chemical durability...
June 16, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28747538/complexing-agents-and-ph-influence-on-chemical-durability-of-type-i-molded-glass-containers
#7
Alberto Biavati, Michele Poncini, Arianna Ferrarini, Nicola Favaro, Martina Scarpa, Marta Vallotto
Among the factors that affect the glass surface chemical durability, pH and complexing agents present in aqueous solution have the main role. Glass surface attack can be also related to the delamination issue causing glass particles' appearance in the pharmaceutical preparation. A few methods to check for glass containers delamination propensity and some control guidelines have been proposed. The present study emphasizes the possible synergy between a few complexing agents with pH on borosilicate glass chemical durability...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28747537/john-sculley-s-noble-cause-disruptive-innovation-to-transform-healthcare
#8
EDITORIAL
Govind Rao
No abstract text is available yet for this article.
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28416646/increasing-patient-safety-by-closing-the-sterile-production-gap-part-3-moist-heat-resistance-of-bioburden
#9
REVIEW
James P Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products, as it affords enhanced safety for the patient because the formulation is sterilized in its sealed, final container. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is the notion that destruction of a high population of a resistant biological indicator microorganism is required...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28416645/performance-stability-of-silicone-oxide-coated-plastic-parenteral-vials
#10
Christopher M Weikart, Carlo G Pantano, Jeff R Shallenberger
A new packaging system was developed for parenteral pharmaceuticals that combines the best attributes of plastic and glass without their respective drawbacks. This technological advancement is based on the synergy between high-precision injection-molded plastics and plasma coating technology. The result is a shatter-resistant, optically clear, low-particulate, and chemically durable packaging system. The demand for this product is driven by the expanding market, regulatory constraints, and product recalls for injectable drugs and biologics packaged in traditional glass materials...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28416644/evaluation-of-different-estimation-methods-for-accuracy-and-precision-in-biological-assay-validation
#11
REVIEW
Binbing Yu, Harry Yang
Biological assays (bioassays) are procedures to estimate the potency of a substance by studying its effects on living organisms, tissues, and cells. Bioassays are essential tools for gaining insight into biologic systems and processes including, for example, the development of new drugs and monitoring environmental pollutants. Two of the most important parameters of bioassay performance are relative accuracy (bias) and precision. Although general strategies and formulas are provided in USP<1033>, a comprehensive understanding of the definitions of bias and precision remain elusive...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28196916/historical-review-of-glasses-used-for-parenteral-packaging
#12
REVIEW
Robert A Schaut, W Porter Weeks
Glass has long been used for packaging precious liquids, in particular pharmaceuticals. Its unique combination of hermeticity, transparency, strength, and chemical durability make it the optimal material for such an important role. Today's life-saving drugs are stored in borosilicate glasses, which evolved from applications in microscope optics and thermometers. As the glass compositions improved, so did the methods used to shape them and the tests used to characterize them. While all of these advances improved the quality of the glass container and its ability to protect the contents, problems still exist such as delamination, cracks, and glass particulates...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28089965/increasing-patient-safety-by-closing-the-sterile-production-gap-part-2-implementation
#13
REVIEW
James P Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high concentration of a resistant biological indicator is required...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28089964/increasing-patient-safety-by-closing-the-sterile-production-gap-part-1-introduction
#14
REVIEW
James P Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high population of a resistant biological indicator is required...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28512178/particulate-generation-mechanisms-during-bulk-filling-and-mitigation-via-new-glass-vial
#15
Christopher Timmons, Chi Yuen Liu, Stefan Merkle
Contamination with foreign particulate matter continues to be a leading cause of parenteral drug recalls, despite extensive control and inspection during manufacturing. Glass is a significant source of particulate matter contamination; however, the mechanism, source, and quantification have not been extensively analyzed. Quantification of particulate matter generation with lab simulations suggests that glass-to-glass contact on the filling line produces large quantities of glass particles of various sizes. A new strengthened glass vial with a low-coefficient of friction (low-COF) surface is proposed to address this root cause of glass particle generation...
May 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28512177/evaluation-of-novel-process-indicators-for-rapid-monitoring-of-hydrogen-peroxide-decontamination-processes
#16
Neil P McLeod, Melanie Clifford, J Mark Sutton
Geobacillus stearothermophilus spores on stainless steel discs are routinely used as Biological Indicators (BIs) for the validation of hydrogen peroxide bio-decontamination processes. Given ongoing concerns about the reliability and response time of BIs, we explored the potential for an enzyme-based approach decontamination process evaluation. Thermostable adenylate kinase (tAK) enzyme was coated onto a solid support and exposed to hydrogen peroxide vapour, in parallel with standard commercial 6-log BIs, during a series of vapour-phase hydrogen peroxide (VPHP) cycles in a flexible film isolator...
May 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28512176/extractables-screening-of-polypropylene-resins-used-in-pharmaceutical-packaging-for-safety-hazards
#17
Dennis Jenke
Pharmaceutical products are packaged in containers so that they can be manufactured, distributed and used. Because extractables from such containers are precursors of leachable impurities in the product, extractables represent potential hazards to user safety. Polypropylene resins are frequently used as materials of construction for packaging of liquid parenteral drug products. Thus extractables profiling of polypropylene resins may be an effective means of hazard identification associated with the resin's safe use...
May 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28512175/2015-2016-quality-risk-management-benchmarking-survey
#18
Kelly Waldron, Emma Ramnarine, Jeffrey Hartman
This paper investigates the concept of Quality Risk Management (QRM) maturity as it applies to the pharmaceutical and biopharmaceutical industries, using the results and analysis from a QRM benchmarking survey conducted in 2015 and 2016. QRM maturity can be defined as the effectiveness and efficiency of a quality risk management program, moving beyond 'check-the-box' compliance with guidelines such as ICH Q9 Quality Risk Management, to explore the value QRM brings to business and quality operations. While significant progress has been made towards full adoption of quality risk management principles and practices across industry, the full benefits of QRM have not yet been fully realized...
May 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28551610/why-is-there-a-problem-with-data-integrity
#19
EDITORIAL
Christopher J Smalley
No abstract text is available yet for this article.
May 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28196929/pda-points-to-consider-technical-product-lifecycle-management-pharmaceutical-quality-system-effectiveness-for-managing-post-approval-changes
#20
Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
No abstract text is available yet for this article.
May 2017: PDA Journal of Pharmaceutical Science and Technology
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