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PDA Journal of Pharmaceutical Science and Technology

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https://www.readbyqxmd.com/read/28089966/revision-of-viable-environmental-monitoring-in-a-development-pilot-plant-based-on-quality-risk-assessment-a-case-study
#1
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
#2
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
#3
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
#4
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
#5
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/27974629/throughput-optimization-of-continuous-biopharmaceutical-manufacturing-facilities
#6
Fernando Antonio Garcia, Michael W Vandiver
In order to operate profitably under different product demand scenarios, biopharmaceutical companies must design their facilities with mass output flexibility in mind. Traditional biologics manufacturing technologies pose operational challenges in this regard due to their high costs and slow equipment turnaround times, restricting the types of products and mass quantities that can be processed. Modern plant design, however, has facilitated the development of lean and efficient bioprocessing facilities through footprint reduction, and adoption of disposable and continuous manufacturing technologies...
December 14, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27974628/quantitative-microbial-risk-assessment-of-pharmaceutical-products
#7
Mostafa Essam Eissa
Monitoring of microbiological quality in the pharmaceutical industry is an important criterion that is required to justify safe product release to the drug market. Good manufacturing practice (GMP) and efficient control on bioburden level of product components are critical parameters that influence microbiological cleanliness of medicinal products. However, since microbial dispersion through the samples follows Poisson distribution, the rate of detection of microbiologically defective samples lambda (λ) decreases when the number of defective units per batch decreases...
December 14, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27974627/simulated-leaching-migration-study-for-a-model-container-closure-system-applicable-to-parenteral-and-ophthalmic-drug-products-podps
#8
Dennis Jenke, Thomas Egert, Alan Hendricker, James Castner, Thomas Feinberg, Christopher Houston, Desmond Hunt, Michael Lynch, Kumudini Nicholas, Daniel L Norwood, Diane Paskiet, Michael Ruberto, Edward J Smith, Frank Holcomb
A simulating leaching (migration) study was performed on a model container-closure system relevant to parenteral and ophthalmic drug products (PODP). This container-closure system consisted of a linear-low density polyethylene bottle (primary container), a polypropylene cap and an elastomeric cap liner (closure), an adhesive label (labeling) and a foil overpouch (secondary container). The bottles were filled with simulating solvents (aqueous salt/acid mixture at pH 2.5, aqueous buffer at pH 9.5, and 1/1(v/v) IPA/water), a label was affixed to the filled and capped bottles, the filled bottles were placed into the foil overpouch and the filled and pouched units were stored either upright or inverted for up to 6 months at 40°C...
December 14, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27974626/bio-compute-objects-a-step-towards-evaluation-and-validation-of-bio-medical-scientific-computations
#9
Vahan Simonyan, Jeremy Goecks, Raja Mazumder
The unpredictability of actual physical, chemical, and biological experiments due to the multitude of environmental and procedural factors is well-documented. What is systematically overlooked, however, is that computational biology algorithms are also affected by multiplicity of parameters and have no lesser volatility. The complexities of computation protocols and interpretation of outcomes is only a part of the challenge: there are also virtually no standardized and industry accepted metadata schemas for reporting the computational objects that record the parameters used for computations together with the results of computations...
December 14, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27974625/kinetic-modeling-of-the-release-of-ethylene-oxide-from-sterilized-plastic-containers-and-its-interaction-with-monoclonal-antibodies
#10
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. 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)...
December 14, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27789805/processing-impact-on-monoclonal-antibody-drug-products-protein-subvisible-particulate-formation-induced-by-grinding-stress
#11
Benson Gikanga, Devon Roshan-Eisner, Robert Ovadia, Eric S Day, Oliver Boris Stauch, Yuh-Fun Maa
Subvisible particle formation in monoclonal antibody (mAb) drug product resulting from mixing and filling operations represents a significant processing risk that can lead to filter fouling and thereby lead to process delays or failures. Several previous studies from our lab and others demonstrated the formation of subvisible particulates in mAb formulations resulting from mixing operations using some bottom-mounted mixers or stirrer bars. It was hypothesized that the stress (e.g. shear/cavitation) derived from tight clearance and/or close contact between the impeller and shaft was responsible for SvP generation...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27789804/an-improved-method-of-predicting-extinction-coefficients-for-the-determination-of-protein-concentration
#12
Eric C Hilario, Alan Stern, Charlie H Wang, Yenny Webb Vargas, Charles J Morgan, Trevor E Swartz, Thomas W Patapoff
Concentration determination is an important method of protein characterization required in the development of protein therapeutics. There are many known methods for determining the concentration of a protein solution, but the easiest to implement in a manufacturing setting is absorption spectroscopy in the ultraviolet region. For typical proteins composed of the standard amino acids, absorption at wavelengths near 280 nm is due to the three amino acid chromophores tryptophan, tyrosine, and phenylalanine in addition to a contribution from disulfide bonds...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27789803/container-closure-integrity-testing-practical-aspects-and-approaches-in-the-pharmaceutical-industry
#13
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger, Klaus Wuchner
The assurance of sterility of a parenteral drug product, prior to any human use, is a regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must demonstrate absence of microbial contamination through leaks as part of the container closure system (CCS) qualification, during manufacturing, for Quality Control purposes and to ensure microbiological integrity (sterility) during storage and shipment up to the end of product shelf life. Current regulatory guidances, which differ between countries and regions, provide limited detail on how to assess CCI...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27789802/a-bayesian-approach-to-determination-of-f-d-and-z-values-used-in-steam-sterilization-validation
#14
Paul Faya, James D Stamey, John W Seaman
For manufacturers of sterile drug products, steam sterilization is a common method used to provide assurance of the sterility of manufacturing equipment and products. The validation of sterilization processes is a regulatory requirement and relies upon the estimation of key resistance parameters of microorganisms. Traditional methods have relied upon point estimates for the resistance parameters. In this paper, we propose a Bayesian method for estimation of the well-known D_T, z, and F_o values that are used in the development and validation of sterilization processes...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27789801/disinfectant-effectiveness-testing-challenges
#15
James N Polarine, Carol Bartnett, David J Shields
Disinfectants and sporicides are critical for microbial contamination control within the pharmaceutical, biotechnology, and medical device industries. GMP manufacturing facilities are expected to demonstrate that the biocides used in controlled environments are efficacious against the facility's environmental isolates on representative surfaces using site-specific preparation methods as described in SOPs. We present common issues highlighted by regulatory inspectors pertaining to disinfectant and sporicide qualification and potential difficulties when performing in vitro efficacy tests...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27974592/dose-uniformity-of-scored-and-unscored-tablets-application-of-the-fda-tablet-scoring-guidance-for-industry
#16
Anthony B Ciavarella, Mansoor A Khan, Abhay Gupta, Patrick J Faustino
PURPOSE: This U.S. Food and Drug Administration (FDA) laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs. METHODS: Whole tablets were purchased from five manufacturers for amlodipine and six for gabapentin. Two splitters were used for each drug product, and the gabapentin tablets were also split by hand. Whole and split amlodipine tablets were tested for content uniformity following the general chapter of the United States Pharmacopeia (USP) Uniformity of Dosage Units <905>, which is a requirement of the new FDA Guidance for Industry on tablet scoring...
November 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27974591/the-effect-of-formulation-process-and-method-variables-on-the-reconstitution-time-in-dual-chamber-syringes
#17
Tobias Werk, Imke S Ludwig, Hanns-Christian Mahler, Joerg Luemkemann, Joerg Huwyler, Mathias Hafner
: Reconstitution time of dried products is influenced by various factors including formulation, process, and reconstitution method itself. This manuscript describes factors affecting reconstitution in a dual chamber syringe using highly concentrated human monoclonal antibody and bovine serum albumin model formulations. Freezing and drying conditions had only minor impact on the reconstitution time, whereas the primary container and thus the geometry of the lyophilization cake played a major role...
November 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27974590/winds-of-change
#18
EDITORIAL
Govind Rao
No abstract text is available yet for this article.
November 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27789800/air-water-binary-gas-integrity-test-for-sterilizing-and-virus-filters
#19
Sal Giglia, John Caulmare, David Nhiem, David Porreca
: Reliability of retention performance is of paramount importance for membrane filters designed for sterile and virus filtration. To achieve dependable retention, an integrity test can be applied to ensure the absence of oversize pores or defects that can compromise the retention capability of the filter. Probably the most commonly applied nondestructive integrity test for membrane filters is the gas-liquid diffusion test, with air and water often used as the gas-liquid pair. However, the sensitivity of the air-water diffusion test is limited by the fact that the diffusive flow rate for an integral membrane can span a range that is large compared to the flow contributed by a defect...
November 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27593693/advanced-virus-detection-technologies-interest-group-avdtig-efforts-on-high-throughput-sequencing-hts-for-virus-detection
#20
Arifa S Khan, Dominick A Vacante, Jean-Pol Cassart, Siemon H S Ng, Christophe Lambert, Robert L Charlebois, Kathryn E King
Several nucleic-acid based technologies have recently emerged with capabilities for broad virus detection. One of these, high throughput sequencing, has the potential for novel virus detection because this method does not depend upon prior viral sequence knowledge. However, the use of high throughput sequencing for testing biologicals poses greater challenges as compared to other newly introduced tests due to its technical complexities and big data bioinformatics. Thus, the Advanced Virus Detection Technologies Users Group was formed as a joint effort by regulatory and industry scientists to facilitate discussions and provide a forum for sharing data and experiences using advanced new virus detection technologies, with a focus on high throughput sequencing technologies...
November 2016: PDA Journal of Pharmaceutical Science and Technology
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