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Cell Culture Process Validation Including Cell Bank Qualification
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Anne B. Tolstrup, Steven I. Max, Denis Drapeau, Timothy S. Charlebois
The International Conference on Harmonization (ICH) has established guidelines containing recommendations for the testing and characterization of cell lines (ICH Topic Q5A, Q5B, Q5D and Q6B). However, the points addressed in the guidelines are not all-inclusive and may be subject to interpretation by the manufacturer. For example, it is expected that the host cell species origin (mouse, hamster, human) is considered when designing appropriate test panel for adventitious virus analysis. Also, awareness of emerging viruses such as Sars-Cov-2, including assessment of the need for specific testing, is required by the sponsor of biotherapeutics used in clinical trials. The following section will focus on efforts to establish and maintain a paradigm for the purity testing and genotypic characterization of CHO cell banks and production cell lines as it relates to industry standards and regulatory expectations. It is the intent of this paradigm to confirm the identity and purity of the cell bank as well as demonstrate the suitability of the cell line for its intended purpose.
Burkholderia cepacia Complex (BCC) in Your Facility
Published in Jeanne Moldenhauer, Disinfection and Decontamination, 2018
However, since this organism is hard to differentiate from other similar organisms and in many cases the publications listed in this report either had the identification testing performed at the Burkholderia cepacia Research Laboratory (recognized worldwide as experts in BCC) and/or performed the testing including Burkholderia cepacia in the test panel, there is a concern as to whether the identification is correct or whether there is a possibility that this is actually Burkholderia cepacia. This is further complicated by another recent lot of product being contaminated with Burkholderia cepacia. Like Burkholderia cepacia this organism has been shown to have significant health concerns to individuals with cystic fibrosis.
The making of “piracy standards”
Published in Hendrik Storstein Spilker, Digital Music Distribution, 2017
We will pick up from actor-network theory three specific concepts. The first one is displacement. An artifact’s movement in space and time can be understood as a series of displacements. A displacement takes place, for example, when an artifact moves (back and forth) from a laboratory to a test panel, to a marketing agency or to different user constituencies. These situations are analyzed as potential sites for breaches in the development of a technology. Confronted with new social groups or new technical elements – for example, the merging of MP3 and DivX with the Internet – new associations and interpretations can be created.
Speech intelligibility test methodology applied to powered air-purifying respirators used in healthcare
Published in Journal of Occupational and Environmental Hygiene, 2020
Susan Xu, Jeremy Simons, Patrick Yorio, Dana Rottach, Ziqing Zhuang, Lewis Radonovich
NIOSH Institutional Review Board approval (HSRB 18-NPPTL-02XP) was obtained prior to test subject recruitment. The NIOSH Standard Test Procedure TEB-CBRN-APR-STP-0313, Determination of Communication Performance Test for Speech Conveyance and Intelligibility of CBRN Full Facepiece APR was used for this study. This STP describes the Communication Performance Tests for Speech Conveyance and Intelligibility of the CBRN APR in sufficient detail to select equipment with the necessary resolution, select the appropriate human subject test panel, conduct the test, and determine whether or not the product passed the test (Centers for Disease Control and Prevention 2007). The STP specified the involvement of eight test subjects: three listeners and five speakers. We deviated from the STP by involving a total of four human subjects who rotated between listening and speaking. The test subjects, recruited from the National Personal Protective Technology Laboratory (NPPTL) test subject pool, did not report hearing impairments, speech defects, or being a non-native English speaker in a pretest questionnaire and did not have facial hair or other conditions that might impair respirator fit. Subjects were trained on the donning and the correct use of the appropriately sized respirator of each model.
Understanding the impact of adhesion on the mechanical behavior of shotcrete
Published in CIM Journal, 2022
E. Karampinos, B. H. Ko, J. Hadjigeorgiou
The numerical investigation focused on reproducing the adhesion failure mechanism observed in the laboratory tests. The shotcrete thickness in the selected laboratory test was 13.3 cm. The Young’s modulus used for the liner elements was based on unconfined compression test results from specimens cut from the test panel specifically for this laboratory test. The tensile strength assigned to the interface properties was based on values from tensile tests of the interface between shotcrete and the surface slabs from core samples cut from the model by Fernandez-Delgado (1977). The elastic contact and shear plastic properties at the interface between the structural liner and the blocks were the result of a series of numerical tests and iterations.
Anaerobic biodegradation of pyrene by Klebsiella sp. LZ6 and its proposed metabolic pathway
Published in Environmental Technology, 2020
Xiang Li, Xueying Zhang, Lian Li, Chaoba Lin, Weiliang Dong, Weiran Shen, Xiaoyu Yong, Honghua Jia, Xiayuan Wu, Jun Zhou
The strain was identified by the GENIII technology of Biolog and 16S ribosomal DNA analysis. The GEN III MicroPlate™ test panel provides a standardized micro method using 94 biochemical tests to profile and identify a broad range of bacteria: 71 carbon source utilization assays and 23 chemical sensitivity assays [28]. The test panel provides a ‘Phenotypic Fingerprint’ of the microorganism that can be used to identify it at the species level.