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PDA Journal of Pharmaceutical Science and Technology

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https://www.readbyqxmd.com/read/30232142/extraction-leaching-of-metal-containing-additives-from-polyvinyl-chloride-ethyl-vinyl-acetate-and-polypropylene-bags-and-infusion-sets-into-infusion-solutions
#1
Denise Bohrer, Patricia Mattiazzi, Carine Viana, Paulo Nascimento, Leandro Carvalho, Marlei Veiga
Flexible medical devices are primarily made of plasticized polyvinyl chloride (PVC). Lately, PVC is being replaced with ethyl vinyl acetate (EVA) and polypropylene (PP) to avoid undesired migration of the PVC plasticizers. Nevertheless, other additives are necessary to generate useful polymeric materials. Metallic species present in such additives can also leach out into the infusion solutions. The migration of Ba, Cd, Sn, Pb, and Zn from devices made from PVC, EVA, and PP was evaluated. Bags and infusion sets were decomposed, and their metallic contents were analyzed...
September 19, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30232141/achieving-%C3%A2-zero%C3%A2-defects-for-visible-particles-in-injectables
#2
Jennifer Johns, Paolo Golfetto, Tia Bush, Gianmaurizio Fantozzi, John Shabushnig, Anthony Perry, Fran DeGrazio, Dorothee Streich, Jahanvi Miller, Herve Soukiassian, Amy Stanton, Rick Watson
The reduction of visible particles in injectable products is an important element in the consistent delivery of high-quality parenteral products. An important part of this effort is the control of particles that may emanate from the primary packaging materials. The Parenteral Drug Association (PDA), with the support of the Pharmaceutical Manufacturers Forum (PMF) has undertaken the task of developing test methods to assess the cleanliness of primary packaging components used in the manufacture of sterile injectable products...
September 19, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30232140/a-case-study-to-address-a-gap-in-the-device-to-vial-interface-stopper-push-in-by-chemo-spikes-an-overlooked-oncology-safety-risk
#3
Xia Cathy Zhao, Le Ho, Daniel L Bantz, Doug Hostetler, Liang Fang
This case study is the first to address the risk, at the device-to-vial interface, of a spike pushing a stopper into a vial. It was performed after healthcare workers at cancer care hospitals complained about the risk of possible exposure to hazardous injectable drugs during the transfer if the spike pushed the stopper into the vial. This case study took a three-step approach to understand the device-to-vial interface, and the factors that determine stopper push-in force threshold and spike puncture force, respectively...
September 19, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30232139/how-one-might-experimentally-determine-if-container-closure-systems-and-their-components-and-materials-of-construction-contribute-elemental-impurities-to-packaged-pharmaceutical-drug-products
#4
Dennis Jenke
The safety aspects of elemental impurities in finished drug products is a topic of considerable importance in the pharmaceutical community and guidelines such as ICH Q3D and USP <232> and <233> have been published to provide directions on how to assess finished drug products with respect to such impurities. Although a drug product's packaging system has been identified as a potential source of elemental impurities, comparable guidelines have not been established for assessing packaging systems, and their materials and components of construction, with respect to their potential to contribute leached elements to packaged drug products...
September 19, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30158240/split-cakes-still-delicious
#5
Philippe Lam, Thomas W Patapoff
"Elegant" lyophilized pharmaceutical product cakes are expected to appear as uniform foamy plugs with little shrinkage and minimal cracking. While studying internal cake structures, we have on occasion observed some cakes that were split horizontally, roughly in halves, with foamy top and lamellar bottom regions. After many years and numerous experiments, we can finally propose a mechanism for the formation of these cakes with unusual internal structures. This phenomenon involves a complex interplay of momentum, heat, mass transfer and phase equilibria...
August 29, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30158239/modeling-the-permeation-rates-of-organic-migrants-through-a-fluoropolymer-film
#6
Liang Fang, Cathy Zhao
Polymer films were widely used as barriers for blocking certain organic molecules (such as leachables and extrables) in both food and parenteral pharmaceutical packaging applications. However, a good understanding of the barrier properties of those polymer films is still lacking for combination drug product manufacturers to make practical risk-based assessment regarding the effectiveness of the barrier films against potential leachables. The present work addressed this issue by a combined theoretical/experimental approach: a new mathematical model based on Hansen Solubility Parameters, the size, and the shape of organic molecules was developed to quantitatively estimate the Steady State Permeation Rate (SSPR) of organic migrants through a model ETFE fluoropolymer film, by considering contributions from both solubility and diffusivity...
August 29, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30158238/conducting-clinical-risk-assessments-for-visible-particulate-matter-in-parenteral-preparations
#7
John D Ayres
Visible particulate matter in injectables presents one important question for consideration: ″What are the potential implications to the patient?″; The risks of visible particulate matter to patient safety have been comprehensively reviewed elsewhere. However, the methods utilized to assess and characterize the risk have been explained with various degrees of specificity and supporting rationale. To date, the assessment process lacks the necessary consensus to permit a more standardized and consistent approach to evaluate the potential patient risks...
August 29, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030359/proceedings-of-2017-viral-clearance-symposium-session-5-facility-risk-mitigation
#8
Junfen Ma, Thomas R Kreil
The discussion on the facility risk mitigation was included in the 2017 viral clearance symposium for the first time. There were a few topics discussed in this session, including sanitization / cleaning against viruses, viral segregation as well as definition of a functionally closed system. Virus inactivation by disinfectants is critical for the biotechnology industry. The efficacy can be different, depending whether applied to surfaces, in solutions or in the gas phases, as well as the respective disinfectants, i...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030358/proceedings-of-2017-viral-clearance-symposium-session-3-resin-life-time
#9
Johannes Bluemel, Junfen Ma
In many down-stream processes, chromatographic purification steps contribute significantly to the overall virus reduction capacity. International Conference on Harmonisation (ICH) guideline ICH Q5A [1] outlines that "Over time and after repeated use, the ability of chromatography columns and other devices used in the purification scheme to clear virus may vary. Some estimate of the stability of the viral clearance after several uses may provide support for repeated use of such columns." Virus reduction studies with used resin normally require a high amount of in-process material and time...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030357/proceedings-of-2017-viral-clearance-symposium-session-4-submission-strategies
#10
Astrid Schwantes, Rachel Specht, Qi Chen
Appropriate performance of virus validation studies and testing of unprocessed bulk harvests for retrovirus particle count are procedures in the demonstration of an acceptable level of viral safety for cell-derived biotechnology products. Product-specific validation studies on virus reduction with two model viruses (usually MuLV and a parvovirus) performed in duplicate runs is standard for clinical trial applications. For the retroviral safety margin normally a 6 log reduction is expected. Retroviral particle counts are measured traditionally by transmission electron microscopy (TEM) and are commonly performed at contract laboratories...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030356/proceedings-of-2017-viral-clearance-symposia-session-2-1-dsp-unit-operations-virus-filtration-inactivation
#11
Thomas R Kreil, David Roush
The manufacturing processes of biological medicinal products are expected to be capable of removing and/or inactivating viruses, to primarily provide for adequate safety margins for patients and to thus satisfy the corresponding regulatory expectations. To achieve this goal, process segments specifically dedicated to the task of virus removal or inactivation are designed into manufacturing flows. The State-of-the-Art now includes virus removal by nanofiltration, but also the more traditional low pH or (solvent-) detergent treatments are widely in use, often to provide for two complementary and mechanically different means of virus clearance...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030355/session-1-1-upstream-mitigation-part-2-virus-barrier-filter-and-htst
#12
Dayue Chen, Glen Bolton
"Cell lines such as CHO, C127, BHK and murine hybridoma cell lines have frequently been used as substrates for drug production with no reported safety problems related to viral contamination of the products" (ICH Q5A). However, viral contamination events in GMP cell culture processes, while rare, do sometimes occur. When contamination happens, it could result in serious consequences, including supply risk of life-saving drugs and substantial financial loss. To mitigate the potential risk of viral contamination, one of the approaches taken by industry is to implement preventative measures upstream...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030354/proceedings-of-2017-viral-clearance-symposium-session-2-2-dsp-unit-operations-purification-unit-operations
#13
David Roush, Thomas R Kreil
The process capability and potential for various forms of chromatography to remove viruses has been discussed in the literature extensively including the observed variability in performance of some unit operations such as protein A and CEX (Miesegaes 2010A, Miesegaes 2010B, Roush 2015). Some unit operations such as AEX have demonstrated robustness over a wide range of operating conditions (Miesegaes 2010B, Roush 2014). The robustness and effectiveness of the AEX step combined with a detailed understanding of the mechanisms that result in virus and impurity partitioning vs...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030353/viral-clearance-symposium-2017-conclusion
#14
Stefan Hepbildikler, Sarah A Johnson, Johannes Bluemel
This report provides a high-level summary of the key outcomes and gaps based on the research presented at the Viral Clearance Symposium 2017, and new areas identified for future study and improvements.
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030352/proceedings-of-2017-viral-clearance-symposia-session-6-ensuring-viral-safety-in-continuous-processing
#15
Sarah A Johnson, David Roush
To ensure successful scale up of continuous processing to large-scale production, seamless incorporation of viral testing and clearance/inactivation into representative small scale models is warranted. For the first time at the viral clearance symposium, a session was held devoted to the adaptation of standard viral clearance/inactivation unit operations to continuous processing, with an emphasis on design of valid small scale models. In this session, the presentations and subsequent discussions identified challenges as well as pathways forward for these emerging technologies...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030351/upstream-mitigation-part-1-cell-bank-and-bulk-harvest-testing
#16
Glen Bolton, Dayue Chen
Monoclonal antibodies (mAbs) are typically produced using mammalian cell lines, which are known to express endogenous retrovirus-like particles (RVLP) and also have the potential to be infected by viruses. This session focused on the detection and measurement of these viruses and RVLP. In the first talk it was demonstrated that Next Generation Sequencing (NGS) can detect, with a similar sensitivity as PCR, viruses in cells without a-priori knowledge of the specific virus and importantly, that a specific NGS approach can decipher whether the signal corresponds to a replicating virus or not...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030350/proceedings-of-the-2017-viral-clearance-symposium-introduction
#17
Stefan Hepbildikler, Franz Nothelfer
This article introduces the white paper from the 2017 Viral Clearance Symposium. The 5th Viral Clearance Symposium 2017 in Penzberg, Germany, addressed regulatory perspectives presented by officials from Health Canada, FDA and PEI, as well as Upstream and Facility risk mitigation, Downstream unit operations, and viral clearance strategies to support novel molecule formats, accelerated scenarios and continuous processing.
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030349/multiproduct-resin-reuse-for-biopharmaceutical-manufacturing-methodology-and-acceptance-criteria
#18
Rizwan Sharnez, Steve Doares, Shane Manning, Krunal Mehta, Ekta Mahajan, Angela To, William Daniels, Judy Glyn, Pankaj Gour, Constanze Guenther, Yunjuan Wang, Derek Foley, Ronan Hayes, Michael Hendershot, Adam Mott, Sunil Prabhu, Dawn Tavalsky, Laura Bass, David Haas, Ashley Hesslein, Norbert Schuelke, Hendri Tjandra
Chromatography resins used for purifying biopharmaceuticals are typically dedicated to a single product. For GMP facilities that make a limited amount of any particular product, this can result in the resin being used for a fraction of its useful life. A proposed methodology for extending resin reuse to multiple products is described. With this methodology, resin and column performance, cleaning effectiveness and product carryover are continually monitored to ensure that product quality is not impacted by multiproduct resin reuse (MRR)...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030348/the-impact-of-quality-culture-on-operational-performance-an-empirical-study-from-the-pharmaceutical-industry
#19
Thomas Friedli, Paul Buess, Stephan Koehler, Cylia Chen, Steven Mendivil, Denyse Baker
Quality Culture as enabler of high quality performance and subsequently as source of competitive advantage is increasingly discussed among OPEX and quality executives. Research studies indicate an impact of quality culture on performance, especially on the success of quality improvement programs such as Total Quality Management initiatives. A continual challenge in quality culture research however remains the lack of practical and accepted metrics to assess culture. In 2014 the Parental Drug Association (PDA) conducted a quality culture survey within the pharmaceutical industry...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/30030347/assessment-of-extractable-elements-from-elastomers
#20
Diane Paskiet, Crystal Kraft, Erica Tullo, Jeff Hunter, Diego Zurbriggen
Compendia methods have historically been used to assess heavy metals in both drug products and packaging material extracts. However, these methods have been found to be inadequate for elemental specificity and accurate measurements. The International Council on Harmonization (ICH) has published the Q3D, Guideline for Elemental Impurities to provide a risk-based approach that specifies elements to be considered in a drug product risk assessment and permitted daily exposures (PDEs) depending on toxicological concern and route of administration...
July 20, 2018: PDA Journal of Pharmaceutical Science and Technology
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