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PDA Journal of Pharmaceutical Science and Technology

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https://www.readbyqxmd.com/read/27789805/processing-impact-on-monoclonal-antibody-drug-products-protein-subvisible-particulate-formation-induced-by-grinding-stress
#1
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
#2
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
#3
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
#4
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
#5
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/27789800/air-water-binary-gas-integrity-test-for-sterilizing-and-virus-filters
#6
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 non-destructive 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...
October 27, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27593693/advanced-virus-detection-technologies-interest-group-avdtig-efforts-for-high-throughput-sequencing-hts-for-virus-detection
#7
Arifa S Khan, Dominick A Vacante, Jean-Pol Cassart, Siemon H S Ng, Christophe Lambert, Robert L Charlebois, Kathryn King
Several nucleic-acid based technologies have recently emerged with capabilities for broad virus detection. One of these, high throughput sequencing (HTS), has the potential for novel virus detection since this method does not depend upon prior viral sequence knowledge. However, the use of HTS for testing biologicals poses greater challenges as compared to other newly-introduced tests due to its technical complexities and big data bioinformatics. Thus, an 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 HTS technologies...
September 4, 2016: 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
#8
Kiyoshi Fujimori, Hans Lee, Joseph Phillips, Yasser Nashed-Samuel
The European Pharmacopeia (Ph. Eur.) 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 12 mm diameter electrode was calibrated with 100 μS/cm conductivity standard and carryover minimized by rinsing the probe in a water beaker per analysis...
September 4, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27593691/multicentre-study-on-incubation-program-for-environmental-monitoring-and-aseptic-process-simulation
#9
Guinet Marie Frédéric Roland, Berthoumieu Nicole, Dutot Philippe, Triquet Julien, Ratajczak Mehdi, Thibaudon Michel, Bechaud Philippe, Arliaud Christophe, Miclet Edith, Giordano Florine, Larcon Marjorie, Arthaud Catherine
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 recommendation 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 manufacturing in situ site studies, we performed a collaborative study at four manufacturing sites with four samples at the same location...
September 4, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27593690/the-application-of-amino-acids-in-freeze-dried-protein-formulations
#10
Peter Stärtzel
The development of freeze dried proteins as a market formulation poses a significant challenge to formulation scientists. The choice of a suitable stabilizer to prevent protein degradation during the process is essential and based on sound knowledge of available excipients and their stabilizing properties. Amino acids have been found to exhibit lyo- and cryoprotective effects similar to those of established stabilizers, such as sugars and/or polymers, but offer a greater diversity of chemical structures and physicochemical properties...
September 4, 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516493/introduction-proceedings-of-the-2015-viral-clearance-symposium
#11
Glen Bolton, Rich Levy
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516492/viral-clearance-using-traditional-well-understood-unit-operations-session-1-2-virus-retentive-filtration
#12
David Roush, Junfen Ma
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516489/session-3-1-protein-a-hydroxyapatite-and-mixed-mode-chromatography
#13
Dayue Chen
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516488/session-1-1-viral-clearance-using-traditional-well-understood-unit-operations-low-ph-and-detergent-viral-inactivation
#14
Junfen Ma, David Roush
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516486/session-4-1-case-studies-of-application-of-generic-claims-and-qbd-for-viral-clearance
#15
Rachel Specht, Meisam Bakhshayeshi
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516485/session-3-2-viral-clearance-of-emerging-unit-operations-membrane-chromatography-other-methods-etc
#16
Christopher Gallo
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516484/session-4-2-viral-spiking-viral-preparation-and-upstream-risk-mitigation-strategies
#17
Meisam Bakhshayeshi, Rachel Specht
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516483/session-2-company-specific-data-on-cycled-resin-testing
#18
Johannes Blümel, Kurt Brorson
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27516482/session-5-conference-summary-key-discussion-and-outcomes-pending-questions-and-proposed-experiments
#19
Glen Bolton, Johannes Blümel
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/27436430/pda-points-to-consider-fundamental-concepts-in-data-integrity
#20
Bob Buhlmann, Madlene Dole, Zena Kaufmann
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
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