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PDA Journal of Pharmaceutical Science and Technology

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 (Healy (5)), 5-parameter logistic curve fits (Prentice (6)) or parallel line analysis (Finney (7)). Lack-of-Fit (LOF) 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...
June 16, 2017: PDA Journal of Pharmaceutical Science and Technology
Anita Bawa, Sophia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Francisco Leira, Kim McFarland, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis, David Baine, Derek Willison-Parry
The biopharmaceutical industry produces non-sterile and/or low-bioburden intermediates and bulk biologics (i.e. Drug Substances) using bioburden controlled processes in accordance to Q7A and Annex 2. In many cases, single mold isolation events have received a high level of scrutiny; the goal of this paper is to challenge this paradigm and provide the rationale for an enhanced control approach that focuses on trending of mold species as microbial indicators rather than on single isolation events. Molds, can also be part (in much lower numbers) of the normal microbial population of a biologics manufacturing facility and, therefore, mold isolation is not an unexpected event in non-aseptic processing environments...
June 16, 2017: PDA Journal of Pharmaceutical Science and Technology
Alberto Biavati, Michele Poncini, Arianna Ferrarini, Nicola Favaro, Martina Scarpa, Marta Vallotto
Among the factors that affect the glass surface chemical durability, pH and complexing agents presence in aqueous solution have the main role (1). Glass surface attack can be also related to the delamination issue with glass particles appearance in the pharmaceutical preparation. A few methods to check for glass containers delamination propensity and some control guidelines have been proposed (2,3). The present study emphasizes the possible synergy between a few complexing agents with pH on the borosilicate glass chemical durability...
June 16, 2017: PDA Journal of Pharmaceutical Science and Technology
Christopher 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 (low-COF) surface is proposed to address this root cause of glass particle generation...
May 15, 2017: PDA Journal of Pharmaceutical Science and Technology
Neil P McLeod, Melanie Clifford, J Mark Sutton
Geobacillus stearothermophilus spores on stainless steel discs are routinely used as Biological Indicators (BIs) for the validation of hydrogen peroxide bio-decontamination processes. Given ongoing concerns about the reliability and response time of BIs, we explored the potential for an enzyme-based approach decontamination process evaluation. Thermostable adenylate kinase (tAK) enzyme was coated onto a solid support and exposed to hydrogen peroxide vapour, in parallel with standard commercial 6-log BIs, during a series of vapour-phase hydrogen peroxide (VPHP) cycles in a flexible film isolator...
May 15, 2017: PDA Journal of Pharmaceutical Science and Technology
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...
May 15, 2017: PDA Journal of Pharmaceutical Science and Technology
Kelly Waldron, Emma Ramnarine, Jeffrey Hartman
This paper investigates the concept of Quality Risk Management (QRM) maturity as it applies to the pharmaceutical and biopharmaceutical industries, using the results and analysis from a QRM benchmarking survey conducted in 2015 and 2016. QRM maturity can be defined as the effectiveness and efficiency of a quality risk management program, moving beyond 'check-the-box' compliance with guidelines such as ICH Q9 Quality Risk Management, to explore the value QRM brings to business and quality operations. While significant progress has been made towards full adoption of quality risk management principles and practices across industry, the full benefits of QRM have not yet been fully realized...
May 15, 2017: PDA Journal of Pharmaceutical Science and Technology
Christopher J Smalley
No abstract text is available yet for this article.
May 2017: PDA Journal of Pharmaceutical Science and Technology
Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
No abstract text is available yet for this article.
May 2017: PDA Journal of Pharmaceutical Science and Technology
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>, European Pharmacopoeia 5.1.6, and Parenteral Drug Association 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 were used...
May 2017: PDA Journal of Pharmaceutical Science and Technology
Dennis R Jenke, Barrett E 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...
May 2017: PDA Journal of Pharmaceutical Science and Technology
Ildikó Ziegler, Judit Borbély-Jakab, 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 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 whether the existing monitoring program met the emerged advanced monitoring practice...
May 2017: PDA Journal of Pharmaceutical Science and Technology
Fernando A 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...
May 2017: PDA Journal of Pharmaceutical Science and Technology
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 and efficient control on bioburden level of product components are critical parameters that influence the microbiological cleanliness of medicinal products. However, because 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...
May 2017: PDA Journal of Pharmaceutical Science and Technology
Benson Gikanga, Devon Roshan Eisner, Robert Ovadia, Eric S Day, Oliver B Stauch, Yuh-Fun Maa
Subvisible particle formation in monoclonal antibody 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 protein subvisible particulate generation...
May 2017: PDA Journal of Pharmaceutical Science and Technology
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
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
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
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
Sau Larry Lee, Kurt Brorson
No abstract text is available yet for this article.
March 2017: PDA Journal of Pharmaceutical Science and Technology
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