Generic Validation Research Articles

Studying Abroad Narrative Imaginaries: North and South Europe

Through analysis of 50 autoethnographies I interpret international students’ imaginaries of Italy-Florence (South Europe), Finland-Helsinki (North Europe) and what can be called “the cosmopolitan elsewhere”. International students’ imaginary of Finland-Helsinki is very slight; that of Italy-Florence is richer and variously articulated: media images and narratives shape students’ expectations before their arrival in the host country. The Finland-Helsinki country profile is instead associated with a vague idea of Northern Europe and often confused with Scandinavia. The respective autoethnographic passages can be synthetically interpreted as past (Italy) vs. present (Finland). On one side Italy-Florence’s image is almost embedded in a cultural past, on the other Finland-Helsinki’s image is almost severed from its history and is seen more as a geographical entity: the deep and mysterious north. Analysis of secondary sources connected with studying abroad reveals the absence of a clear-cut narrative of what it means to be an international student. Nevertheless, there is a glimpse of a vague cosmopolitan narrative. This story, constructed on a global scale by different actors and institutions upholds the generic validity of studying abroad for both instrumental and expressive reasons, and sees it as an institutionalized rite of passage towards global citizenship.

Symmetric and Dual PRFs from Standard Assumptions: A Generic Validation of a Prevailing Assumption

A two-input function is a dual PRF if it is a PRF when keyed by either of its inputs. Dual PRFs are assumed in the design and analysis of numerous primitives and protocols including HMAC, AMAC, TLS 1.3 and MLS. But, not only do we not know whether particular functions on which the assumption is made really are dual PRFs; we do not know if dual PRFs even exist. What if the goal is impossible? This paper addresses this with a foundational treatment of dual PRFs, giving constructions based on standard assumptions. This provides what we call a generic validation of the dual PRF assumption. Our approach is to introduce and construct symmetric PRFs, which imply dual PRFs and may be of independent interest. We give a general construction of a symmetric PRF based on a function having a weak form of collision resistance coupled with a leakage hardcore function, a strengthening of the usual notion of hardcore functions we introduce. We instantiate this general construction in two ways to obtain two specific symmetric and dual PRFs, the first assuming any collision-resistant hash function and the second assuming any one-way permutation. A construction based on any one-way function evades us and is left as an intriguing open problem.

UmetaFlow: an untargeted metabolomics workflow for high-throughput data processing and analysis

Metabolomics experiments generate highly complex datasets, which are time and work-intensive, sometimes even error-prone if inspected manually. Therefore, new methods for automated, fast, reproducible, and accurate data processing and dereplication are required. Here, we present UmetaFlow, a computational workflow for untargeted metabolomics that combines algorithms for data pre-processing, spectral matching, molecular formula and structural predictions, and an integration to the GNPS workflows Feature-Based Molecular Networking and Ion Identity Molecular Networking for downstream analysis. UmetaFlow is implemented as a Snakemake workflow, making it easy to use, scalable, and reproducible. For more interactive computing, visualization, as well as development, the workflow is also implemented in Jupyter notebooks using the Python programming language and a set of Python bindings to the OpenMS algorithms (pyOpenMS). Finally, UmetaFlow is also offered as a web-based Graphical User Interface for parameter optimization and processing of smaller-sized datasets. UmetaFlow was validated with in-house LC–MS/MS datasets of actinomycetes producing known secondary metabolites, as well as commercial standards, and it detected all expected features and accurately annotated 76% of the molecular formulas and 65% of the structures. As a more generic validation, the publicly available MTBLS733 and MTBLS736 datasets were used for benchmarking, and UmetaFlow detected more than 90% of all ground truth features and performed exceptionally well in quantification and discriminating marker selection. We anticipate that UmetaFlow will provide a useful platform for the interpretation of large metabolomics datasets.Graphical

Untangling the systematic dilemma behind the roughskin spurdog Cirrhigaleus asper (Merrett, 1973) (Chondrichthyes: Squaliformes), with phylogeny of Squalidae and a key to Cirrhigaleus species.

Cirrhigaleus comprises a small genus of rare barbel-bearing dogfish sharks with distributions in limited regions of all oceans. Generic validity and taxonomic status of some species are upon controversies by morphological and molecular evidence that often suggest reallocation of Cirrhigaleus species into the genus Squalus. Particularly, the roughskin spurdog C. asper exhibits intermediary morphological characteristics within Squalidae that requires clarification. In the present study, a phylogenetic approach was undertaken to test the correct generic placement of C. asper using novel and revised morphological characters. We performed maximum parsimony analysis of 51 morphological characters of the internal (e.g., neurocranium, clasper cartilages, pectoral and pelvic girdles) and external anatomy applied to 13 terminal taxa. Cirrhigaleus represents a valid genus and it is supported by eight synapomorphies: high number of monospondylous vertebrae; medial nasal lobe supported by fleshy core and innervated by the buccopharyngeal branch of the facial nerve; neurocranium with greatest width across nasal capsules; one facet and one condyle in the puboischiadic bar for articulating with the basipterygium; two intermediate segments between the basipterygium of the pelvic fin and the axial cartilage of the claspers; five terminal clasper cartilages; and posterior medial process of the puboischiadic bar absent. Cirrhigaleus asper is sister-species to a small clade comprising C. barbifer and C. australis which is supported by one synapomorphy, presence of conspicuous cusplets in the dermal denticles. Cirrhigaleus barbifer, C. asper and C. australis are redescribed herein and the neotype of C. barbifer is designated. A key to Cirrhigaleus species is also given and the inner relationships within Squalus is tentatively discussed.

Cross-platform comparison of arbitrary quantum states

As we approach the era of quantum advantage, when quantum computers (QCs) can outperform any classical computer on particular tasks, there remains the difficult challenge of how to validate their performance. While algorithmic success can be easily verified in some instances such as number factoring or oracular algorithms, these approaches only provide pass/fail information of executing specific tasks for a single QC. On the other hand, a comparison between different QCs preparing nominally the same arbitrary circuit provides an insight for generic validation: a quantum computation is only as valid as the agreement between the results produced on different QCs. Such an approach is also at the heart of evaluating metrological standards such as disparate atomic clocks. In this paper, we report a cross-platform QC comparison using randomized and correlated measurements that results in a wealth of information on the QC systems. We execute several quantum circuits on widely different physical QC platforms and analyze the cross-platform state fidelities.

Caboellimma, a new genus for “Ellimma” cruzae Santos, 1990, an ellimmichthyiform fish (Teleostei: Clupeomorpha) from the Cabo Formation (Lower Cretaceous) of the Pernambuco-Paraíba Basin, north-east Brazil

Caboellimma gen. nov. is erected to accommodate “Ellimma” cruzae, an archaic herring-like fish known only from the Lower Cretaceous mudrocks assigned to the Cabo Formation in north-east Brazil. Although Caboellimma cruzae comb. nov. shows a mix of characters between Ellimma branneri and species of Ellimmichthys, it does possess remarkable features indicating more complex affinities than previously thought, such as: (1) a transversely narrow and very elongate parietal; (2) of the dermal bones of the skull roof, only the frontal is ornamented; (3) a supraoccipital commissural canal runs the parietal through a straight tube; (4) there is a long parietal branch of supraorbital sensory canal reaching the boundary with the parietal and a long curved branch towards the otic region; (5) in contrast with nominal species of Ellimma, tubercles and “cannabis leaf”-shaped ornament on predorsal scutes are lacking; (6) a very reduced post-parietal region of the skull roof. Since its original description, anatomical data on “Ellimma” cruzae have been considered insufficient for comparative purposes causing problems in cladistic analyses. Here we present a comprehensive redescription; the generic validity is tested with a parsimony analysis performed with the TNT 1.5 program, including 19 selected ellimmichthyiform taxa and 63 unweighted and unordered characters. Only a single tree (L = 181 steps; CI = 0.403; RI = 0.520) has been obtained, the topology of which indicates placement of Caboellimma cruzae comb. nov. far from Ellimma and appearing as sister group of Thorectichthys marocensis.

Mitophylogenomics of the zoonotic fluke Echinostoma malayanum confirms it as a member of the genus Artyfechinostomum Lane, 1915 and illustrates the complexity of Echinostomatidae systematics.

The complete mitochondrial genome (mitogenome or mtDNA) of the trematode Echinostoma malayanum Leiper, 1911was fully determined and annotated. The circular mtDNA molecule comprised 12 protein-coding genes (PCGs) (cox1 - 3, cob, nad1 - 6, nad4L, atp6), two mitoribosomal RNAs (MRGs) (16S or rrnL and 12S or rrnS), and 22 transfer RNAs (tRNAs or trn), and a non-coding region (NCR) rich in long and short tandem repeats (5.5 LRUs/336bp/each and 7.5 SRUs/207bp/each). The atp8 gene is absent and the 3' end of nad4L overlaps the 5' end of nad4 by 40bp. Special DHU-arm missing tRNAs for Serine were found for both tRNASer1(AGN) and tRNASer2(UCN). Codons of TTT (for phenylalanine), TTG (for leucine), and GTT (for valine) were the most, and CGC (for Arginine) was the least frequently used. A similar usage pattern was seen in base composition, AT and GC skewness for PCGs, MRGs, and mtDNA* (coding cox3 to nad5) in E. malayanum and Echinostomatidae. The nucleotide use is characterized by (T > G > A > C) for PCGs/mtDNA*, and by (T > G ≈ A > C) for MRGs. E. malayanum exhibited the lowest genetic distance (0.53%) to Artyfechinostomum sufrartyfex, relatively high to the Echinostoma congeners (13.20-13.99%), higher toHypoderaeum conoideum (16.18%), and the highest to interfamilial Echinochasmidae (26.62%); Cyclocoelidae (30.24%); and Himasthlidae (25.36%). Topology indicated the monophyletic position between E. malayanum/A. sufrartyfex and the group of Echinostoma caproni, Echinostoma paraensei, Echinostoma miyagawai, and Echinostoma revolutum, rendering Hypoderaeum conoideum and unidentified Echinostoma species paraphyletic. The strictly closed genomic/taxonomic/phylogenetic features (including base composition, skewness, codon usage/bias, genetic distance, and topo-position) reinforced Echinostoma malayanum to retake its generic validity within the Artyfechinostomum genus.

Redescription of Conniella apterygia Allen and its reassignment in the genus Cirrhilabrus Temminck and Schlegel (Teleostei: Labridae), with comments on cirrhilabrin pelvic morphology

Conniella apterygia is redescribed from re-examination of the holotype, two paratypes, and six additional specimens. The genus is closely allied to Cirrhilabrus, sharing similarities in general morphological and meristic details, but is separated from Cirrhilabrus and most other labrid fishes in lacking pelvic fins and a pelvic girdle. Recent molecular phylogenetic studies have provided strong evidence for the deep nesting of Conniella within Cirrhilabrus, contradicting its generic validity and suggesting that the loss of pelvic elements is autapomorphic. Consequently, the species is redescribed and assigned to the genus Cirrhilabrus, as Cirrhilabrus apterygia new combination. The pelvic morphologies of related cirrhilabrin labrids are discussed, and a new synapomorphy is identified for Paracheilinus.

Multivariate wavelet leaders Rényi dimension and multifractal formalism in mixed Besov spaces

In this paper, we first establish a general lower bound for the multivariate wavelet leaders Rényi dimension valid for any pair [Formula: see text] of functions on [Formula: see text] where [Formula: see text] belongs to the Besov space [Formula: see text] with [Formula: see text] and [Formula: see text] belongs to [Formula: see text] with [Formula: see text]. We then prove the optimality of this result for quasi all pairs [Formula: see text] in the Baire generic sense. Finally, we compute both iso-mixed and upper-multivariate Hölder spectra for all pairs [Formula: see text] in the same [Formula: see text]-set. This allows to prove (respectively, study) the Baire generic validity of the upper-multivariate (respectively, iso-multivariate) multifractal formalism based on wavelet leaders for such pairs.

Elastography Validity Criteria Definition Using Numerical Simulations and MR Acquisitions on a Low-Cost Structured Phantom

MR Elastography is a novel technique enabling the quantification of mechanical properties in tissue with MRI. It relies on a three-step process that includes the generation of a mechanical vibration, motion capture using dedicated MR sequences, and data processing involving inversion algorithms. If not properly tuned to the targeted application, each of those steps may impact the final outcome, potentially causing diagnostic errors and thus eventually treatment mismanagement. Different approaches exist that account for acquisition or reconstruction errors, but simple tools and metrics for quality control shared by both developers and end-users are still missing. In this context, our goal is to provide an easily deployable workflow that uses generic validity criteria to assess the performance of a given MRE protocol, leveraging numerical simulations with an accessible experimental setup. Numerical simulations are used to help both determining sets of relevant acquisition parameters and assessing the data processing's robustness. Simple validity criteria were defined, and the overall pipeline was tested in a custom-built, structured phantom made of silicone-based material. The latter have the advantage of being inexpensive, easy to handle, facilitate the fabrication of complex structures which geometry resembles the anatomical structures of interest, and are longitudinally stable. In this work, we successfully tested and evaluated the overall performances of our entire MR Elastography pipeline using easy-to-implement and accessible tools that could ultimately translate in MRE standardized and cost-effective procedures.

The Feasibility of an Euler–Lagrange Approach for the Modeling of Wet Steam

Abstract This study investigates the applicability of an Euler–Lagrange approach for the calculation of nucleation and condensation of steam flows. Supersonic nozzles are used as generic validation cases, as their high expansion rates replicate the flow conditions in real turbines. Experimental and numerical validation data for these nozzles are provided by the International Wet Steam Modeling Project of Starzmann et al. (2018, “Results of the International Wet Steam Modeling Project,” Proc. Inst. Mech. Eng. A, 232(5), pp. 550–570). In contrast to most participants of that project, an Euler–Lagrange approach is utilized for this study. Therefore, the classical nucleation theory with corrections and different droplet growth laws is incorporated into the discrete phase model of ansysfluent. Suggestions for an efficient implementation are presented. The Euler–Lagrange results show a good agreement with the experimental and numerical validation data. The sensitivities of the Euler–Lagrange approach to modeling parameters are analyzed. Finally, an optimal parameter set for the calculation of nucleation and condensation is proposed.

On the generation of validated manufacturing process optimization and control schemes

Manufacturing process related functionalities, like optimization and control, are in general demanding in terms of data, computational time and efficiency. However, there are no generic certification or validation schemes that can be followed. In particular, only ISO application can verify the suitability of operations up to an extent. The current work utilizes an enhanced version of Blockchain so that functionalities at the process level can be certified as per a particular scheme. The concept of ledger is elaborated to this end, to manipulate knowledge and be able to handle it like an asset that is exchanged. Thus, a specific generic framework is proposed, herein, to reassure that the right kind of information has been exchanged during process control and optimization. Furthermore, expert distributed agents are utilized to turn knowledge into certified procedures. Encryption issues are also regarded, providing safety and security as extra characteristics. The case study of thermal process control is regarded in this sense to prove the complementary character of these concepts and the usability of the framework. Finally, the existence of additional features within this loop is discussed, like the validation of quantifying concepts like resource streams.

Requirements Engineering in Software Startups: A Systematic Mapping Study

Startups have high failure rates due to their inability to attain a sufficient product/market fit, i.e., delivering a solution that best matches the user needs in the market. Requirement engineering is the activity that could help startup teams identify the value proposition that provides high value to the users and continuously innovate it. The objective of the study is to analyse the state of art of the requirement engineering research in the context of startups, as available in the literature. The analysis of the research area highlights the research trends to achieve two things i.e., (a) predict how much support the startups can get from the literature for enhancing their success rates and (b) identify the research gaps to motivate researchers to conduct future research that could be adoptable in startup contexts. Systematic mapping is conducted on studies extracted from the four bibliographic databases (IEEExplore, ACM, Springerlink and ScienceDirect) and studies extracted by using a forward snowballing approach. Individual studies are coded to yield the classification scheme. Formulated schemes and those already available in literature, were populated with information extracted from the abstracts of the studies. The research is mostly focused on generic requirement engineering and product validation activities. The research is conducted mostly as evaluations (empirical studies) with the outcome of providing theory to the research community. Major underlying motivation of the research is to attain the product/market fit. However, research studies focusing on requirement documentation, prioritization and elicitation are losing focus from 2017, 2018 and 2019, respectively. The literature lacks the studies that reports research solutions which are validated in laboratory settings or in real contexts, experience reports, opinion papers and philosophical papers. The positive side of the finding is that the number of requirement engineering research studies in a startup context have increased in the past five years. At this instant, unfortunately the literature has limited ability to support startups by providing solutions (for instance, research solutions, evidence to support decision makings, best practices, experiences etc.) that are adoptable in their real context. Uniform focus of the researchers across all sub-activities of requirement engineering is required with effort distributed across different research types that supports startups, not only by providing validated solutions but experience reports, opinions, new conceptual frameworks and empirical evidence that can aid their decision making.

Generic Protocols for the Analytical Validation of Next-Generation Sequencing-Based ctDNA Assays: A Joint Consensus Recommendation of the BloodPAC's Analytical Variables Working Group.

Liquid biopsy, particularly the analysis of circulating tumor DNA (ctDNA), has demonstrated considerable promise for numerous clinical intended uses. Successful validation and commercialization of novel ctDNA tests have the potential to improve the outcomes of patients with cancer. The goal of the Blood Profiling Atlas Consortium (BloodPAC) is to accelerate the development and validation of liquid biopsy assays that will be introduced into the clinic. To accomplish this goal, the BloodPAC conducts research in the following areas: Data Collection and Analysis within the BloodPAC Data Commons; Preanalytical Variables; Analytical Variables; Patient Context Variables; and Reimbursement. In this document, the BloodPAC’s Analytical Variables Working Group (AV WG) attempts to define a set of generic analytical validation protocols tailored for ctDNA-based Next-Generation Sequencing (NGS) assays. Analytical validation of ctDNA assays poses several unique challenges that primarily arise from the fact that very few tumor-derived DNA molecules may be present in circulation relative to the amount of nontumor-derived cell-free DNA (cfDNA). These challenges include the exquisite level of sensitivity and specificity needed to detect ctDNA, the potential for false negatives in detecting these rare molecules, and the increased reliance on contrived samples to attain sufficient ctDNA for analytical validation. By addressing these unique challenges, the BloodPAC hopes to expedite sponsors’ presubmission discussions with the Food and Drug Administration (FDA) with the protocols presented herein. By sharing best practices with the broader community, this work may also save the time and capacity of FDA reviewers through increased efficiency.

<p><strong><em>Entosthodon elimbatus </em>(Bryophyta, Funariaceae), a new species from the sub-alpine region in Yunnan and <em>E. physcomitrioides </em>new for mainland China</strong></p>

Entosthodon elimbatus W.Z. Ma, Shevock & S. He, a new species from a sub-alpine area in Yunnan, China, is described here based on morphological and molecular data. Morphologically, the new species resembles the widespread species E. buseanus, but differs most notably in having significantly shortened setae, smaller capsules and nearly unbordered laminae. Images from the scanning electron microscope also show compound-papillose ornamentation over the spore surface, which is characteristic of this new species. The generic validation of the new species in Entosthodon is supported by a phylogenetic analysis based on the plastid rps4 sequence. Entosthodon physcomitrioides, characterized by its well-developed apophysis and peristome, is confirmed as a new record for mainland China. Detailed descriptions and illustrations for both species are provided.

A forward approach for the validation of soot sizing models using laser-induced incandescence (LII)

While validating the numerical modeling of the primary particle size distribution (PPSD) in sooting flames, a common practice is to compare the numerical results to the corresponding experimental data obtained with the Time-Resolved Laser-Induced Incandescence (TiRe-LII) technique. Since the PPSD is not directly measured by TiRe-LII, but derived with a post-processing procedure, various uncertainties and errors can potentially affect the consistency of such comparison requiring the estimation of many input parameters. On the contrary, nowadays, detailed numerical simulations provide access to a more complete set of data, which can be used to reconstruct the incandescence signal. In this work, a forward approach for the generic validation of numerical models for the PPSD is performed. It is based on the numerical reconstruction of the temporal evolution of the incandescence from the numerical results and its comparison with the measured signal. First, two indexes are proposed to quantify the agreement between the numerically synthesized and the measured signals. Then, the effectiveness of the proposed approach is demonstrated a priori by quantifying the potential errors that can be avoided with this new strategy compared to the classical approach. Finally, the feasibility of the proposed procedure is proven by comparing synthesized signals to the experimental ones available in the literature for a laminar premixed flame. It is shown that the proposed approach can be used for strengthening the analysis on numerical model performances in addition to the classical approach.

A mass spectrometry guided approach for the identification of novel vaccine candidates in gram-negative pathogens

Vaccination is the most effective method to prevent infectious diseases. However, approaches to identify novel vaccine candidates are commonly laborious and protracted. While surface proteins are suitable vaccine candidates and can elicit antibacterial antibody responses, systematic approaches to define surfomes from gram-negatives have rarely been successful. Here we developed a combined discovery-driven mass spectrometry and computational strategy to identify bacterial vaccine candidates and validate their immunogenicity using a highly prevalent gram-negative pathogen, Helicobacter pylori, as a model organism. We efficiently isolated surface antigens by enzymatic cleavage, with a design of experiment based strategy to experimentally dissect cell surface-exposed from cytosolic proteins. From a total of 1,153 quantified bacterial proteins, we thereby identified 72 surface exposed antigens and further prioritized candidates by computational homology inference within and across species. We next tested candidate-specific immune responses. All candidates were recognized in sera from infected patients, and readily induced antibody responses after vaccination of mice. The candidate jhp_0775 induced specific B and T cell responses and significantly reduced colonization levels in mouse therapeutic vaccination studies. In infected humans, we further show that jhp_0775 is immunogenic and activates IFNγ secretion from peripheral CD4+ and CD8+ T cells. Our strategy provides a generic preclinical screening, selection and validation process for novel vaccine candidates against gram-negative bacteria, which could be employed to other gram-negative pathogens.

Validation of Stratification-Driven Phytoplankton Biomass and Nutrient Concentrations in the Northeast Atlantic Ocean as Simulated by EC-Earth

We validated simulations of the Earth system model (ESM) EC-Earth-NEMO of present-day temperature, salinity, nutrient, and chlorophyll a profiles with in situ observations in the Northeast Atlantic Ocean (29–63º N). Simulations with standard parametrization (run 1) and improved parametrization of vertical mixing (run 2) were compared. Run 1 showed shallower mixed layer depths (MLDs) in spring as compared to observations owing to lower salinities in the upper 200 m of the subpolar North Atlantic (>55º N). This coincided with a mismatch with observed timing and magnitude of the phytoplankton spring bloom. In contrast, the model performed well south of 55º N. Run 2 showed improved springtime MLD, phytoplankton dynamics, and nutrient distributions in the subpolar North Atlantic. Our study underlines the sensitivity of subpolar North Atlantic phytoplankton blooms to surface freshening, suggesting that future fresh-water inflow from Arctic and Greenland Ice sheet melting could significantly affect phytoplankton productivity. These findings contribute to the generic validation of the EC-Earth ESM and underline the need for rigorous validation of physics-biology links, in particular the sub polar North Atlantic where complex seasonal stratification/vertical mixing processes govern upper ocean phytoplankton productivity.

On the Baire Generic Validity of thet-Multifractal Formalism in Besov and Sobolev Spaces

Thet-multifractal formalism is a formula introduced by Jaffard and Mélot in order to deduce thet-spectrum of a functionffrom the knowledge of the(p,t)-oscillation exponent off. Thet-spectrum is the Hausdorff dimension of the set of points wherefhas a given value of pointwiseLtregularity. The(p,t)-oscillation exponent is measured by determining to which oscillation spacesOp,ts(defined in terms of wavelet coefficients)fbelongs. In this paper, we first prove embeddings between oscillation and Besov-Sobolev spaces. We deduce a general lower bound for the(p,t)-oscillation exponent. We then show that this lower bound is actually equality generically, in the sense of Baire’s categories, in a given Sobolev or Besov space. We finally investigate the Baire generic validity of thet-multifractal formalism.

Use of leftovers of monoclonal antibody products after partial extraction - A microbiological safety study.

In the absence of thorough microbiological, chemical and physical stability data, high amounts of pharmaceutical products, from which the seal has been broken, are to be discarded after preparation. We performed a generic microbiological validation study for several marketed monoclonal antibody products, in order to define conditions under which leftovers from partially extracted product can be used in order to minimize loss. From the daily practice of the Central Preparation Unit of the Netherlands Cancer Institute, used monoclonal antibody product vials were collected. To examine the integrity of the primary packaging, a VDT/S Vacuum Leak tester from Erweka was used. Vials were punctured with different types of spikes or a needle prior to experiments and examined for leakage afterward. In addition, microbiological monitoring was performed by broth simulation of the preparation method. All vials (631 vials, 18 different monoclonal antibody products) showed no leakage after puncturing with a 18 G needle. However, the use of a spike system resulted in leakage in 108 of the 435 tested vials. Results from the broth simulations confirmed a higher risk of contamination after puncturing with a spike as compared to needle-punctured vials (0.5% vs. 0.05%). When working under aseptic preparation conditions and making use of appropriate needle, the risk of contamination is acceptably low to justify storage and reuse of leftover monoclonal antibody product from a microbiological perspective. The spikes tested lead to an unacceptably high level of loss of integrity and subsequent risk of microbiological contamination if stored in a non-classified environment. We concluded that these results could be applied generically to all monoclonal antibody products with a primary packaging composed of a glass vial and rubber stopper.