journal
MENU ▼
Read by QxMD icon Read
search

PDA Journal of Pharmaceutical Science and Technology

journal
https://www.readbyqxmd.com/read/29030532/mechanistic-investigation-on-grinding-induced-subvisible-particle-formation-during-mixing-and-filling-of-monoclonal-antibody-formulations
#1
Benson Gikanga, Ada Hui, Yuh-Fun Maa
Processing equipment involving grinding of two solid surfaces has been demonstrated to induce subvisible particle (SvP) formation in monoclonal antibody (mAb) drug product manufacturing processes. This study elucidated potential stress types associated with grinding action to identify the stress mechanism responsible for SvP formation. Several potential stress types can be associated with the grinding action, including interfacial stresses (air-liquid and liquid-solid), hydraulic/mechanical shear stress, cavitation, nucleation of stressed protein molecules, and localized thermal stress...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030531/impact-of-formulation-variables-on-silicone-oil-distribution-and-functionality-of-prefilled-syringe-system
#2
Galen H Shi, Sharon L Shinkle, Ganapathy Gopalrathnam, Xia Dong, Jeffrey D Hofer, Eric C Jensen, Natarajan Rajagopalan
The interior surface of prefilled syringes is typically coated with silicone oil for lubrication to aid in free plunger movement. This article discusses the impact and interaction of formulation variables with silicone oil within the interior surface of the barrel. Characterization techniques including syringe glide force, break loose force, ZebraSci imaging, contact angle, ICP, and RapID were used in assessing the interactions. Data indicate formulation variables of pH, buffer and tonicity agent type and concentration and surfactant can impact silicone oil distribution of prefilled syringes leading to changes in functional properties of the syringe over time...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030530/quality-of-medicines-in-portugal-a-retrospective-review-of-medicine-recalls-2005-2015
#3
Ana Reis, Bruna Berardo, Rui Loureiro
INFARMED, the Portuguese national health authority, alerts the general public and healthcare professionals about quality or safety issues detected in health products. The present study analyses substandard medicines recalls in Portugal between 2005 and 2015. All 338 alerts for medicine recalls were analysed, which represents a total of 378 drugs withdrawn. Despite the fact that the total number of medicine alerts has increased during the past decade, the number of actual medicine recalls remained relatively constant...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030529/microbiological-test-data-assuring-data-integrity
#4
Edward Charles Tidswell, Tim Sandle
Marketed drugs and devices possess specifications including critical microbiological quality attributes purposed to assure efficacy and patient safety. These attributes are legislated requirements intended to protect the recipient patient. Sampling, microbiological testing, interpretation of data for final products, raw materials and intermediates all contribute to a cohesive assessment in the assurance of finished product quality. Traditional culture-based microbiological methods possess inherent and unavoidable variability, recognized by the compendia and which might lead to erroneous conclusion pertaining to product quality...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030528/real-time-pcr-detection-of-burkholderia-cepacia-in-pharmaceutical-products-contaminated-with-low-levels-of-bacterial-contamination
#5
Luis Jimenez, Theranda Jashari, Jenifer Vasquez, Stephanie Zapata, Joy Bochis, Margarita Kulko, Victoria Ellman, Matthew Gardner, Tina Choe
A Real-Time (RT) PCR assay was developed to detect Burkholderia cepacia in pharmaceutical products contaminated with low levels of bacterial contamination. Different pharmaceutical suspensions were artificially contaminated with B. cepacia, Escherichia coli, Staphylococcus aureus, and Bacillus megaterium. After a 24-hour incubation in TSB with Tween 20, samples were streaked on mannitol salt, phenyl ethyl alcohol, eosin methylene blue, MacConkey, and pseudomonas isolation agar. Microbial DNA was extracted from each sample by using a Tris-EDTA, proteinase K, Tween 20 buffer...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030527/holistic-considerations-in-optimizing-a-sterile-product-package-to-ensure-container-closure-integrity
#6
Fran L DeGrazio
A new major chapter dealing with container closure integrity (CCI) was released by the United States Pharmacopeial Convention (USP). Chapter <1207> provides a significant amount of education and guidance concerning test methodologies to prove that a system is integral and safe for use. The test method used is only one of the major considerations in approaching the challenge of proving an integral system. This paper takes a holistic review of all the major considerations needed in qualifying a new vial system for container closure integrity...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29030526/guidelines-for-risk-based-changeover-of-biopharma-multi-product-facilities
#7
Rob Lynch, David B, Kathleen Bellorado, Peter Canisius, Douglas Heathcote, Alan Johnson, Ned Wymann, Derek Willison-Parry
In multi-product Biopharma facilities, the protection from product contamination due to the manufacture of multiple products simultaneously, is paramount to assure product quality. To that end, the use of traditional changeover methods (elastomer change-out, full sampling, etc.) have been widely used within the industry and have been accepted by regulatory agencies. However, with the endorsement of Quality Risk Management , the use of risk based approaches may be applied to assess and continuously improve established changeover processes...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928294/factors-affecting-reduction-of-reference-endotoxin-standard-activity-caused-by-chelating-agent-detergent-matrices-kinetic-analysis-of-low-endotoxin-recovery
#8
Masakazu Tsuchiya
Reduction of reference standard endotoxin (RSE) activity was kinetically analyzed under low endotoxin recovery (LER) conditions, and was considered as an apparent first-order reaction. Temperature, pH, and salt concentrations affected the rates of reduction of RSE activity. Temperature appeared to be the most important factor affecting LER. Components of LER matrices, such as citrate and polysorbate 20 showed similar LER effect at concentrations commonly used. Phosphate concentrations showed negative correlation against the half-life of RSE activity in solutions containing phosphate buffer and polysorbate 20...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928293/comparison-of-a-lyophilized-drug-product-to-other-solid-and-liquid-media-for-the-extraction-of-elastomeric-oligomers-from-a-butyl-rubber-stopper
#9
Steven A Zdravkovic
Lyophilization is commonly used to extend the shelf life of pharmaceutical products which are otherwise unstable when stored as a liquid formulation. However, the ability of a lyophilized drug, or other solid medium, to leach or extract substances from a pharmaceutical packaging material is not well characterized. To provide insight into this area of uncertainty, the extraction properties of a lyophilized drug product, the lyophilized drug product reconstituted in water, and several other solid and liquid media of varying polarity were determined using a glass vial with a butyl rubber stopper as a representative pharmaceutical packaging system...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928292/elastomer-change-out-justification-for-minimizing-the-removal-of-elastomers-in-order-to-prevent-cross-contamination-in-a-multiproduct-facility
#10
Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood, Derek Willison-Parry
The primary objective of any Biopharmaceutical Product Changeover (PCO) program is to employ control strategies before, during, and after the manufacturing process, as well as from the beginning of the lifecycle approach for the equipment and validation, which will minimize the opportunity for cross- contamination when switching between products. Evaluation of the need for an Elastomer Change Out (ECO) should be considered as a segment of an overall changeover assessment. Lifecycle systems (e.g. Preventive Maintenance (PM), Cleanability Coupon Testing, Good Engineering Practices, etc...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928291/inhibiting-sterilization-induced-oxidation-of-large-molecule-therapeutics-packaged-in-plastic-parenteral-vials
#11
Jeffrey R Vieregg, Steven J Martin, Adam P Breeland, Christopher M Weikart, Matthew V Tirrell
For many years, glass has been the default material for parenteral packaging, but the development of advanced plastics such as cyclic olefin polymers (COP) and the rapidly increasing importance of biologic drugs have provided new choices, as well as more stringent performance requirements. In particular, many biologics must be stored at non-neutral pH, where glass is susceptible to hydrolysis, metal extraction, and delamination. Plastic containers are not susceptible to these problems, but suffer from higher gas permeability and a propensity for sterilization-induced radical generation, heightening the risk of oxidative damage to sensitive drugs...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928290/enhancing-patient-safety-through-the-use-of-a-pharmaceutical-glass-designed-to-prevent-cracked-containers
#12
Robert A Schaut, Kyle C Hoff, Steven E DeMartino, William K Denson, Ronald L Verkleeren
An essential role of packaging material for the storage and delivery of drug products is to provide adequate protection against contamination and loss of sterility. This is especially important for parenteral containers, as lack of sterility or contamination can result in serious adverse events including death. Nonetheless, cracked parenteral containers are an important source of container integrity failures for injectable drugs and pose a serious risk for patients. Despite significant investments in inspection technology, each year many injectable drugs are investigated and recalled for sterility risks associated with cracked borosilicate containers...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29025998/you-like-us
#13
EDITORIAL
Govind Rao
No abstract text is available yet for this article.
September 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28819050/pda-pac-iam-2017-survey-on-post-approval-change-is-the-regulatory-environment-hindering-much-needed-innovation-in-the-pharma-industry
#14
Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kara Follman, Karolyn Gale, Kassidy Good, Suzanne Kiani, Maik Jornitz, Morten Munk, Kevin O'Donnel, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther, Denyse Baker, Rich Levy
No abstract text is available yet for this article.
September 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28733334/application-of-recombinant-factor-c-reagent-for-the-detection-of-bacterial-endotoxins-in-pharmaceutical-products
#15
Jay Bolden, Kelly 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...
September 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
#16
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, 5-parameter logistic curve fits or parallel line analysis. Lack-of-fit 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. We present a novel lack-of-fit approach that overcomes the shortcomings of previously described lack-of-fit tests, such as the conventional analysis of variance (ANOVA) F-test and the lack-of-fit sum of squares test...
September 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
#17
Anita Bawa, Sofia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Fran Leira, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis, David Bain
No abstract text is available yet for this article.
September 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
#18
Christopher L 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 surface is proposed to address this root cause of glass particle generation...
September 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
#19
N P McLeod, M Clifford, J M Sutton
Geobacillus stearothermophilus spores on stainless steel discs are routinely used as biological indicators for the validation of hydrogen peroxide bio-decontamination processes. Given ongoing concerns about the reliability and response time of biological indicators, we explored the potential for an enzyme-based approach to decontamination process evaluation. Thermostable adenylate kinase enzyme was coated onto a solid support and exposed to hydrogen peroxide vapour, in parallel with standard commercial 6-log biological indicators, during a series of vapour-phase hydrogen peroxide cycles in a flexible film isolator...
September 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
#20
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...
September 2017: PDA Journal of Pharmaceutical Science and Technology
journal
journal
32079
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"