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PDA Journal of Pharmaceutical Science and Technology

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https://www.readbyqxmd.com/read/28416646/increasing-patient-safety-by-closing-the-sterile-production-gap-part-3-moist-heat-resistance-of-bioburden
#1
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...
April 17, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28416645/performance-stability-of-silicon-oxide-coated-plastic-parenteral-vials
#2
Christopher M Weikart, Carlo G Pantano, Jeff R Schallenberger
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...
April 17, 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
#3
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...
April 17, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28289128/characterizing-the-overall-derivatization-of-conjugated-oligomeric-proteins
#4
Michaela Wendeler, Wei Zhao, Christopher Thompson, Manuel Baca, Dhanesh Gadre, Xiangyang Wang, Harry Yang
The analysis and accurate quantitation of bioconjugations proves challenging in the case of oligomeric proteins, especially when the size of the molecule or the nature of the conjugate do not allow the analysis of the intact protein under native conditions. In this case, analytical methods are frequently applied that result in a dissociation of non-covalently linked subunits. This limits the analysis to a description of individual subunits, thereby obscuring the accurate characterization of the overall functionalization...
March 13, 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
#5
Emma Ramnarine, Ursula Busse, Franck Chassant, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
The International Council for Harmonisation Quality Guideline 10 (ICH Q10) describes the Pharmaceutical Quality System (PQS), indicating it is intended to apply throughout a product's lifecycle, in conjunction with good manufacturing practice (GMP) requirements, in order to achieve quality in a consistent and reproducible manner. Implementation of an effective PQS is essential for a company to achieve product realization, establish and maintain a state of control, and facilitate continual improvement (1). When changes are made during the commercial life of a product, an effective PQS, product and process understanding, and use of quality risk management should ensure that product quality, patient safety, and adequate supply to patients are maintained; this, according to ICH Q10-Annex 1, should provide companies the opportunity to manage post-approval changes (PAC) with reduced regulatory oversight (1)...
February 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28196917/validation-of-milliflex%C3%A2-quantum-for-bioburden-testing-of-pharmaceutical-products
#6
Oliver Gordon, Marcel Goverde, Alexandra Staerk, David Roesti
This article reports the validation strategy used to demonstrate that the Milliflex® Quantum yielded non-inferior results to the traditional bioburden method. It was validated according to USP <1223>, Ph. Eur. 5.1.6 and PDA Technical Report No. 33 and comprised the validation parameters Robustness, Ruggedness, Repeatability, Specificity, Limit of Detection and Quantification, Accuracy, Precision, Linearity, Range and Equivalence in Routine Operation. For the validation, a combination of pharmacopeial ATCC strains as well as a broad selection of in-house isolates was used...
February 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28196916/historical-review-of-glasses-used-for-parenteral-packaging
#7
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...
February 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28196915/proper-accounting-for-surface-area-to-solution-volume-ratios-in-exaggerated-extractions
#8
Dennis Jenke, Barrett Rabinow
When drug products contact plastic manufacturing components, packaging systems and/or delivery devices, leachables from the plastics can accumulate in the drug product, potentially affecting its key quality attributes. Given practical issues associated with screening drug products for leachables, potential leachables are frequently surfaced as extractables revealed in extraction studies. To facilitate extractables discovery and identification and to shorten extraction times, extraction studies can be exaggerated and/or accelerated...
February 14, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28396563/emerging-technology-as-a-key-enabler-for-modernizing-pharmaceutical-manufacturing
#9
EDITORIAL
Sau Larry Lee, Kurt Brorson
No abstract text is available yet for this article.
March 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28089966/revision-of-viable-environmental-monitoring-in-a-development-pilot-plant-based-on-quality-risk-assessment-a-case-study
#10
Ildikó No Ziegler, Judit No Borbély-Jakab, Lilla No Lilla Sugó, Réka J Kovács
In this case study, the principles of Quality Risk Management were applied to review sampling points and monitoring frequencies in the Hormonal Tableting unit of a Formulation Development Pilot Plant. In the cleanroom area premises of different functions are located, therefore a general method was established for the risk evaluation based on the Hazard Analysis and Critical Control Points (HACCP) method to evaluate these premises (i.e. production area itself and ancillary clean areas) from the point of view of microbial load and state in order to observe if the existing monitoring program met the emerged advanced monitoring practice...
January 15, 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
#11
James Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products as 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...
January 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28089964/increasing-patient-safety-by-closing-the-sterile-production-part-1-introduction
#12
James Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products as 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...
January 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28089963/pda-paper
#13
Emma Ramnarine
Changes occur throughout a product's commercial life - changes in raw materials, manufacturing equipment, processes, sites, analytical methods, and suppliers. A product Marketing Authorization Holder (MAH) can introduce manufacturing changes as part of continual improvement to enable implementation of innovative technologies, exchange obsolete equipment, or improve the availability of drug products for patients. Changes are also made to comply with evolving regulatory requirements. Changes are a common and unavoidable part of a product's lifecycle...
January 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28089962/mycoplasma-clearance-and-risk-analysis-in-a-model-bioprocess
#14
Julie Wang, Sarah Johnson, Matthew Brown, Scott Lute, Cyrus Agarabi, Alena Dabrazhynetskaya, Vladimir Chizhikov, Kurt Brorson
Mycoplasmas are a type of bacteria that lack cell walls and are occasional cell culture contaminants. In a biotechnology setting, because they can pass through 0.2 μm filters, mycoplasmas could pose a potential patient safety hazard if undetected contaminants from the production culture were not completely removed by downstream biotechnology manufacturing. In this study we investigated the ability of typical commercial monoclonal antibody (mAb) purification operations to clear and kill mycoplasmas, using Acholeplasma laidlawii as a model organism...
January 15, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28174258/kinetic-modeling-of-the-release-of-ethylene-oxide-from-sterilized-plastic-containers-and-its-interaction-with-monoclonal-antibodies
#15
Bryan Lei Yu, Jun Han, Matthew Hammond, Xuemei Wang, Qingchun Zhang, Andrew Clausen, Ronald Forster, Mingda Eu
Ethylene oxide (ETO) is commonly used to sterilize plastic containers, but the effects of residual amounts left after sterilization on protein therapeutics are still not well understood. Here we focus primarily on the factors that influence concentrations of ETO migrating from ETO-treated plastic containers into aqueous solution. A study was designed to investigate the kinetics of this process at various temperatures, and the kinetic data could be fit with a model based on a combination of Fickean diffusion and first-order chemical reaction (to account for observed hydrolysis of ETO)...
January 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28174257/discussing-tomorrow-s-regulatory-risks-today
#16
EDITORIAL
Beth Junker
No abstract text is available yet for this article.
January 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27789801/disinfectant-effectiveness-testing-challenges
#17
Carol Bartnett, James N Polarine, David J Shields
No abstract text is available yet for this article.
January 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27593692/development-of-conductivity-method-as-an-alternative-to-titration-for-hydrolytic-resistance-testing-used-for-evaluation-of-glass-vials-used-in-pharmaceutical-industry
#18
Kiyoshi Fujimori, Hans Lee, Joseph Phillips, Yasser Nashed-Samuel
The European Pharmacopeia surface test to analyze the hydrolytic resistance is a common industrial method to understand and ensure the quality of produced glass vials. Hydrolytic resistance is evaluated by calculating the alkalinity of water extract from autoclaved vials by titration. As an alternative to this titration technique, a conductivity technique was assessed, which directly measures the ions in the water extract. A conductivity meter with a 12 mm diameter electrode was calibrated with a 100 μS/cm conductivity standard and carryover minimized by rinsing the probe in a water beaker per analysis...
January 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27593691/multicenter-study-on-incubation-conditions-for-environmental-monitoring-and-aseptic-process-simulation
#19
Roland Guinet, Nicole Berthoumieu, Philippe Dutot, Julien Triquet, Medhi Ratajczak, Michel Thibaudon, Philippe Bechaud, Christophe Arliaud, Edith Miclet, Florine Giordano, Marjorie Larcon, Catherine Arthaud
Environmental monitoring and aseptic process simulations represent an integral part of the microbiological quality control system of sterile pharmaceutical products manufacturing operations. However, guidance documents and manufacturers practices differ regarding recommendations for incubation time and incubation temperature, and, consequently, the environmental monitoring and aseptic process simulation incubation strategy should be supported by validation data. To avoid any bias coming from in vitro studies or from single-site manufacturing in situ studies, we performed a collaborative study at four manufacturing sites with four samples at each location...
January 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516491/evaluation-of-the-recovery-rate-of-different-swabs-for-microbial-environmental-monitoring
#20
Marcel Goverde, Julian Willrodt, Alexandra Staerk
Contact plates, dipslides, and swabs are used for the microbiological monitoring of surfaces in controlled environments such as pharmaceutical clean rooms. In the present study, three different swab types using two different methods (direct streaking on agar versus elution followed by membrane filtration) were evaluated. In a first study, representative surfaces in pharmaceutical clean rooms were artificially inoculated using three different environmental strains (in vitro study). In a second study, a naturally inoculated floor was swabbed with the same three swab types, again using the two different recovery methods (in situ study)...
January 2017: PDA Journal of Pharmaceutical Science and Technology
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