Product Quality Attributes Research Articles

Effects of incorporation of hempseed meal on the quality attributes of chicken sausage

The effects of incorporation of hempseed meal on the quality attributes of chicken sausage was explored. Hempseed meal was hydrated and added to chicken sausage in the proportion of 10%, 20%, 30%, and 40%, respectively, and the changes of the product quality attributes were analyzed. Results showed that with the increment of hempseed meal, moisture, protein, and lipid content of chicken sausage were significantly decreased, while ash and total dietary fiber content increased. The emulsion stability of the sausage was improved, and the cooking loss decreased. The addition of hempseed meal also increased the total phenolic content and DPPH radical scavenging activity; however, it promoted lipid oxidation (p<0.05), possibly due to the increased unsaturated fatty acids from hempseed meal. The L* and a* values of chicken sausage were significantly reduced due to the increasing content of hempseed meal. The incorporation of hempseed meal modified the texture profile of chicken sausage, which curtailed hardness, cohesiveness, gumminess, springiness, chewiness, and resilience of the chicken sausages, except adhesiveness. This study demonstrated that the incorporation of hempseed meal in chicken sausage could be potential to substitute meat, create an alternative high plant protein sausage, and expand the application of hempseed meal in food industry.

Transcriptomic analysis reveals mode of action of butyric acid supplementation in an intensified CHO cell fed‐batch process

Process intensification is increasingly used in the mammalian biomanufacturing industry. The key driver of this trend is the need for more efficient and flexible production strategies to cope with the increased demand for biotherapeutics predicted in the next years. Therefore, such intensified production strategies should be designed, established, and characterized. We established a CHO cell process consisting of an intensified fed‐batch (iFB), which is inoculated by an N‐1 perfusion process that reaches high cell concentrations (100 × 106 c ml−1). We investigated the impact of butyric acid (BA) supplementation in this iFB process. Most prominently, higher cellular productivities of more than 33% were achieved, thus 3.5 g L−1 of immunoglobulin G (IgG) was produced in 6.5 days. Impacts on critical product quality attributes were small. To understand the biological mechanisms of BA in the iFB process, we performed a detailed transcriptomic analysis. Affected gene sets reflected concurrent inhibition of cell proliferation and impact on histone modification. These translate into subsequently enhanced mechanisms of protein biosynthesis: enriched regulation of transcription, messenger RNA processing and transport, ribosomal translation, and cellular trafficking of IgG intermediates. Furthermore, we identified mutual tackling points for optimization by gene engineering. The presented strategy can contribute to meet future requirements in the continuously demanding field of biotherapeutics production.

COMPARATIVE ANALYSIS OF CUSTOMER SATISFACTION BETWEEN CORNER BAKEY AND CAFE AND MM BAKERY IN BENGKALIS

This study aims to analyze differences in customer satisfaction between Corner Bakery and Cafe and MM Bakery, determine the factors that differentiate customer satisfaction between Corner Bakery and Cafe and MM Bakery. The type of research is comparative research with a quantitative approach. The population in this study was all consumers of Corner Bakery and Cafe and MM Bakery in Bengkalis. The number of samples in the study was 100 people. The data analysis used is descriptive statistics analysis. The dimensions used to measure customer satisfaction of the two bakery shops are product quality, service quality, emotional factors, and price. The study result that customer satisfaction of Corner Bakery and Cafe gets a better rating than MM Bakery based on dimensions of product quality, service quality, and emotional factors. The results also show that service quality is the most factor that differentiate customer satisfaction between Corner Bakery and Cafe and MM Bakery with a difference value around 0.21.

Spectroscopy-Based Local Modeling Method for High-Throughput Quantification of Nucleic Acid Loading in Lipid Nanoparticles.

Lipid nanoparticles (LNPs) are the most widely investigated delivery systems for nucleic acid-based therapeutics and vaccines. Loading efficiency of nucleic acids may vary with formulation conditions, and it is considered one of the critical quality attributes of LNP products. Current analytical methods for quantification of cargo loading in LNPs often require external standard preparations and preseparation of unloaded nucleic acids from LNPs; therefore, they are subject to tedious and lengthy procedures, LNP stability, and unpredictable recovery rates of the separated analytes. Here, we developed a modeling approach, which was based on locally weighted regression (LWR) of ultraviolet (UV) spectra of unpurified samples, to quantify the loading of nucleic acid cargos in LNPs in-situ. We trained the model to automatically tune the training library space according to the spectral features of a query sample so as to robustly predict the nucleic acid cargo concentration and rank loading capacity with similar performance as the more complicated experimental approaches. Furthermore, we successfully applied the model to a wide range of nucleic acid cargo species, including antisense oligonucleotides, single-guided RNA, and messenger RNA, in varied lipid matrices. The LWR modeling approach significantly saved analytical time and efforts by facile UV scans of 96-well sample plates within a few minutes and with minimal sample preprocessing. Our proof-of-concept study presented the very first data mining and modeling strategy to quantify nucleic acid loading in LNPs and is expected to better serve high-throughput screening workflows, thereby facilitates early-stage optimization and development of LNP formulations.

Characterization and Value Assignment of a Monoclonal Antibody Reference Material, NMIJ RM 6208a, AIST-MAB.

Monoclonal antibodies have been established as the largest product class of biopharmaceuticals. Since extensive characterization is required for development and quality control of monoclonal antibody, a widely available reference material (RM) is needed. Herein, a humanized IgG1κ monoclonal antibody reference material, RM 6208-a, AIST-MAB, was established by the National Metrology Institute of Japan, National Institute of Advanced Industrial Science and Technology (NMIJ/AIST). The monoclonal antibody solution was produced as a pharmaceutical grade using a Chinese hamster ovary-derived cell line. The assigned indicative value represents the concentration of the antibody with a heterotetrameric structure including oligomeric forms, determined by an amino acid analysis using isotope dilution mass spectrometry, and their homogeneity and stability were assessed. In addition to antibody concentration, various physicochemical properties, including peptide mapping data, charge variants, and aggregates, were examined. This RM is intended for use in validation of analytical procedures and instruments such as a system suitability test for quantification of antibody. It is also intended for comparing and evaluating the results of antibody analyses across analytical methods and analytical laboratories such as inter-laboratory comparison. Both the material and the set of data from our study provide a tool for an accurate and reliable characterization of product quality attributes of monoclonal antibodies in biopharmaceutical and metrology communities.

Are Local Dairy Products Better? Using Principal Component Analysis to Investigate Consumers' Perception towards Quality, Sustainability, and Market Availability.

Simple SummaryThe perception of the local production concept significantly varies depending on the weight given to each defining component (e.g., quality and sustainability), which in turn depends both on the considered food product and on the consumers’ characteristics. In this research, a survey was conducted to investigate the consumer preferences for milk and cheese quality aspects and their perception of sustainability descriptors of local dairy products. In addition, the effect of socio-demographic variables on consumer preferences and attitudes definition was also explored. From the Principal Component Analysis, four main components were defined (Responsive to quality attributes, Local is better, Local is sustainable, and Availability request), combining the consumer answers about milk and cheese quality preferences and the sustainability and availability opinion. The obtained results highlight the importance of product quality aspects in the considered geographical area (South-East Italy), which is strictly linked to traditional dairy production. Higher availability and visibility of local dairy products on the market were requested by the considered consumer sample. In addition, our results showed that gender, age, place of residence, educational level, and family size significantly affected the local dairy products consumption orientation definition. These findings will support the development of more efficient and transparent communication among dairy producers and consumers in the selected market.Consumers are increasingly aware of the benefits of local foods in terms of quality, sustainability, animal welfare, and safety. This research addresses two main questions: (i) is the perception towards sustainability aspects of local dairy products related to individuals’ preferences for milk and cheese quality aspects? (ii) are these perceptions related to people’s socio-demographic characteristics? For this purpose, a choice experiment was conducted online in Apulia (South-East Italy) involving a sample of 543 respondents. A Principal Component Analysis (PCA) was applied to analyze the consumer opinion related to dairy products’ quality attributes, sustainability, and availability on the market. From the PCA, four main components (accounting the 64.5% of the total explained variance) were defined, highlighting non-overlapping choice styles of consumers, distinguished by attitudes primarily based on quality attributes of dairy products rather than sustainability characteristics or perceived higher quality of local products. Furthermore, the Availability request component described the consumer need for higher availability and/or visibility of local dairy products on the market. The effect of gender, age, and educational status of individuals emerged as significantly important for the resulting component definitions. The obtained results clearly suggest the need to increase the efficiency of communication strategies concerning local dairy products, as well as local dairy products’ availability and visibility on the markets.

Viscosity Reduction and Stability Enhancement of Monoclonal Antibody Formulations Using Derivatives of Amino Acids

Monoclonal antibodies are complex molecules that often require high concentration formulations to meet clinical requirement and bulk drug substance storage. Stability is a common concern in both high and low concentration formulations, however, high concentration formulations are further complicated by an increase in viscosity, leading to manufacturing and administration challenges. To manage stability and viscosity, drug developers typically use salt, amino acids, sugars, polyols, and surfactant. It is possible that excipients control some of the product quality attributes (CQAs), at the cost of several others. In this paper, we have evaluated several amino acid derivatives and identified bis acetyl lysine and propionyl serine to be efficient and superior to commonly used parenteral excipients for minimizing antibody solution viscosity, as well as mitigating physical and chemical degradation by controlling protein-protein interactions and deamidation.

Improvements on sample preparation and peptide separation for reduced peptide mapping based multi-attribute method analysis of therapeutic monoclonal antibodies using lysyl endopeptidase digestion

The mass spectrometry based multi-attribute method (MAM) has gained popularity in the field of biopharmaceutical analysis as it promises a single method for comprehensive monitoring of multiple product quality attributes (PQAs) and product purity. Sample preparation for protein digestion and peptide separation are critical considerations for a reduced peptide mapping-based MAM. To avoid desalting steps required in most tryptic protein digestion and in order to improve peptide separation for hydrophilic peptides, we developed an improved robust sample preparation using lysyl endopeptidase (Lys-C) for high-throughput MAM testing. Additionally, this method optimizes the peptide retention and separation of a stability-indicating VSNK peptide using a HSS T3 column for comprehensive PQA monitoring. A fully automated sample preparation had similar assay variations for PQAs monitoring compared to manual sample preparation. To the best of our knowledge, this is the first report of a high-resolution MS-based MAM using a streamlined Lys-C digestion without desalting with enhanced PQA monitoring for hydrophilic peptides. The improved, robust MAM workflow for protein digestion and peptide separation will pave the way for broader MAM qualification and its applications for the characterization and quality control of therapeutic monoclonal antibodies.

The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives.

The use of physiologically based pharmacokinetic(PBPK) modeling to support the drug product quality attributes, also known as physiologically based biopharmaceutics modeling (PBBM) is an evolving field and the interest in using PBBM is increasing. The US-FDA has emphasized on the use of patient centric quality standards and clinically relevant drug product specifications over the years. Establishing an in vitro in vivo link is an important step towards achieving the goal of patient centric quality standard. Such a link can aid in constructing a bioequivalence safe space and establishing clinically relevant drug product specifications. PBBM is an important tool to construct a safe space which can be used during the drug product development and lifecycle management. There are several advantages of using the PBBM approach, though there are also a few challenges, both with in vitro methods and in vivo understanding of drug absorption and disposition, that preclude using this approach and therefore further improvements are needed. In this review we have provided an overview of experience gained so far and the current perspective from regulatory and industry point of view. Collaboration between scientists from regulatory, industry and academic fields can further help to advance this field and deliver on promises that PBBM can offer towards establishing patient centric quality standards.

Mixing of Monoclonal Antibody Formulated Drug Substance Solutions in Square Disposable Vessels

Fill & finish manufacturing processes of biologics drug product involve multiple unit operations. In particular they often include a mixing step to reduce non-uniformities in fluids by eliminating gradients of concentration and pH may occur during freezing. This step should be conducted carefully to avoid any degradation of the protein under mechanical stress.This study was aimed at characterizing disposable vessels of square cross-section such as Levmixer® from Sartorius Stedim in terms of fluid dynamics and mixing in turbulent regime. The investigation included two tree large vessels (50, 200 & 650-l) and one 4-l vessel designed in house. For that purpose, the impact of stirrer speed, filling volume and duration of mixing on product quality attributes were studied, using a surrogate. Moreover, a scale-up rule, based on first principle, was established and allows prediction of the mixing time as a function of stirring speed and filling volume. A lab-scale test, using drug product, was performed at the same stress intensity but for a much longer duration than the commercial operation and did not reveal any trend to aggregation. Finally, based on the correlation, lab scale stress test and a single verification test at large scale, a design space within which the product can be processed without altering product quality was proposed

Commentary: Multiplex dPCR and SV-AUC are Promising Assays to Robustly Monitor the Critical Quality Attribute of AAV Drug Product Integrity

Adeno-associated viral (AAV) capsids are an emerging vector technology for a number of novel gene therapy modalities (including transgene delivery and CRISPR gene editing). In this commentary, the proper approach to managing uncertainty (described by Rosenberg et al., 2012) when determining critical quality attributes is stated and applied retrospectively to Peginesatide and prospectively to AAV drug product integrity. With Peginesatide, the omission of advanced analytical techniques (for particles) led to a severe safety risk that appeared post marketing. Peginesatide was withdrawn from the market. One of the critical quality attributes of AAV capsid products is drug product integrity. Drug product integrity is critical because it is related to measuring the active dose of product and because the effects of empty, aggregated, particulate, and partial capsids on efficacy and safety are uncertain. The dose of an AAV capsid vector is typically measured as genomes per milliliter. Regulatory agencies have already recommended digital PCR (dPCR) methods because traditional real-time PCR methods were not precise enough for drug product characterization. However, even with dPCR methods, the practice of characterizing AAV product with a simple empty-full ratio is problematic because simplex dPCR methods count partial genomes as full genomes. The proper management of uncertainty requires a robust quantitative measurement of AAV drug product integrity to ensure control of efficacy and safety. Multiplex dPCR and SV-AUC are promising technologies that together have the potential to enable the development of assays fit for the purpose of measuring AAV drug product integrity more precisely.

Industry 4.0 in Action: Digitalisation of a Continuous Process Manufacturing for Formulated Products

The pharmaceutical industry is going through a significant change to adopt smart manufacturing for more integrated supply chains and improved sustainability. Today's competitive market demands have put pressure on healthcare systems to take a comprehensive assessment of the drug life cycle, its environmental effect, industrial use of energy and resources, supply chain, and impact on end-users. The exploitation of emerging Industry 4.0 technologies will allow a sustainable process design and personalised health care system through the realisation of digital twins, which could transform the pharmaceutical sector to be more flexible, robust, adaptive, and smart. A significant level of research and development has been applied to pharmaceutical manufacturing especially in existing, outdated design and scale-up paradigms in isolated unit operations. However, addressing the key challenges in pharmaceutical manufacturing requires whole systems approaches to incorporate Industry 4.0 concepts.This paper aims to share the latest development of an advanced digital twin of a continuous wet granulation and tableting process at The University of Sheffield. These include the delivery of a digital platform consisting of an Advanced Process Control system (APC), mechanistic model platform and industrial IoT platform for data analytics and visualisation. The combined solution aligns with the concepts of Industry 4.0 by providing a digital twin, cloud integration, sophisticated statistical, as well as hybrid and mechanistic models. The models are in turn, used for soft-sensors, Model Predictive Control and Optimisation algorithms to predict and control product Quality Attributes. The potential application of digital twins in the pharmaceutical industry will also be explored.

Multi-Attribute Monitoring and the Multi-Attribute Method: A Powerful Double Act for Supporting Biopharmaceutical Manufacturing

As biopharmaceutical manufacturers look towards implementing solutions for real-time process monitoring, the availability of simple, yet informative analytical methods is required. In this article, we discuss the combination of multi-attribute monitoring using Protein A affinity chromatography coupled to mass spectrometry (MS) for rapid trending of product quality attributes (PQAs) during upstream processing, with the multi-attribute method (MAM) for site-specific analysis of PQAs and new peak detection to determine adherence to specifications. Working together, these multi-attribute approaches represent a powerful combination for advanced process control.

“Local Production”: What Do Consumers Think?

Since the mid-1990s, there has been a growing interest among consumers and producers in downscaling to a local level the length of the agri-food chains as a solution for fairer and more sustainable food production systems. From the point of view of consumption, the attribute “local” is assuming an important role in defining food purchasing preferences, both in terms of expectations of product quality and in terms of its perceived relevance in determining the supply chain sustainability. This research aims to define how individuals’ perception of local production influences the definition of “local” among consumers based on a survey submitted to a sample of 500 consumers in North-Western Italy. The paper provides: (i) a semantic map built on keywords adopted by the respondents to describe local production; (ii) a categorization of food consumers divided in clusters on the basis of their eating styles; and (iii) a characterization of consumers clusters according to the preferences and knowledge expressed towards local production. The results show that consumers’ awareness and attitudes towards the concept of the “local” are influenced by the joint effect of their socio-demographic profile and their food consumption style, with some unexpected evidences that would deserve to be deepen with further research. However, given this uncertainty, three main traits seem to characterize the consumers attitude towards the “local”: a positive relation among the dimensions of environment, local development and product quality and the strength of the link between local production and the reduction of the length of the supply chain. Ultimately, territoriality is perceived as an index of higher product quality (seasonal, therefore fresh and genuine).

Engineering redox sensors into CHO cells enables near-real-time quantification of intracellular redox in bioprocesses.

The production of biologics that treat complex diseases, such as cancer, autoimmune, and infectious disease, requires careful monitoring and control of cell cultures. While bioprocess optimizations have dramatically improved production yields, a lack of analytical tools has made it challenging to identify accompanying intracellular improvements. Intracellular redox can diminish the growth and productivity of biologics-producing cells and adversely impact product quality profiles yet characterizing redox is challenging due to its complex and highly transient nature. In this study, we integrated a fluorescent thiol-based redox biosensor to monitor intracellular redox in one bisAb- and two monoclonal antibody-producing clonal cell lines in a 14-day fed-batch bioreactor. We characterized biosensor functionality using three fluorescence measurement techniques and determined sensor oxidation correlates with the intracellular ratio of reduced (GSH)and oxidized glutathione (GSSG), an important cellular antioxidant. Our fed-batch bioreactor studies showed that sensor expression minimally affected bioprocess outcomes, including growth, productivity, product quality attributes, or intracellular redox attributes, including mitochondrial reactive oxygen species and total cellular GSH levels in all cell lines tested. Biosensor measurements taken throughout the culture revealed that the intracellular environment in these cell lines became more reduced throughout the culture, with the exception of a high pH condition which became more oxidized. Our results demonstrate the potential of using biosensors to monitor intracellular changes in near-real-time with minimal process effects, thus potentially improving future bioprocess optimizations.

Asuransi dan Pandemi Covid-19: Peran Persepsi Konsumen dalam Keputusan Pembelian

Consumer perception is a view or thought process used to make decisions in buying products or services that will be consumed. One of them is in purchase of insurance. This study aims to determine the influence of consumer perception on insurance purchase decisions at PT. Prudential Life Assurance during the Covid-19 pandemic in Bandung. This consumer perception is divided into 6 dimensions consisting of store image, product quality, price, promotion, service quality, and value. This research method uses quantitative. The population in this study are all Prudential customers who live in Bandung. The sampling technique used is non-probability sampling with purposive sampling type with a sample size of 100 people. Data was collected by means of a questionnaire. The data analysis technique used is multiple linear regression analysis. The results of the study showed that consumer perception had a positive and significant effect on purchase decision. The dimension of service quality has a significant effect on purchase decision, while the dimensions of store image, product quality, price, promotion, and value have no significant effect on purchase decision. The dimension of service quality is the dimension of the consumer perception variable which dominantly influences purchase decision

Microwave Cooking Enriches the Nanoscale and Short/Long-Range Orders of the Resulting indica Rice Starch Undergoing Storage.

The chain reorganization of cooked starch during storage plays an important role in the performance of starchy products such as rice foods. Here, different analytical techniques (such as small-angle X-ray scattering) were used to reveal how microwave cooking influences the chain assembly of cooked indica rice starch undergoing storage for 0, 24, or 48 h. While stored, more short-range double helices, long-range crystallites, and nanoscale orders emerged for the microwave-cooked starch than for its conventionally cooked counterpart. For instance, after storage for 24 h, the microwave-cooked starch contained 46.8% of double helices, while its conventionally cooked counterpart possessed 34.3% of double helices. This could be related to the fact that the microwave field caused high-frequency movements of polar groups such as hydroxyls, which strengthened the interactions between starch chains and water molecules and eventually their assembly into double helices, crystallites, and nanoscale orders. This work provides further insights into the chain reassembly of microwave-cooked starch undergoing storage, which is closely related to the quality attributes of starch-based products.

Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.

Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry. Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with currently over 200 approved biosimilars, globally. The key step towards achieving a successful biosimilar approval is to establish analytical and clinical biosimilarity with the innovator. The objective of an analytical biosimilarity study is to demonstrate a highly similar profile with respect to variations in critical quality attributes (CQAs) of the biosimilar product, and these variations must lie within the range set by the innovator. This comprises a detailed comparative structural and functional characterization using appropriate, validated analytical methods to fingerprint the molecule and helps reduce the economic burden towards regulatory requirement of extensive preclinical/clinical similarity data, thus making biotechnological drugs more affordable. In the last decade, biosimilar manufacturing and associated regulations have become more established, leading to numerous approvals. Biosimilarity assessment exercises conducted towards approval are also published more frequently in the public domain. Consequently, some technical advancements in analytical sciences have also percolated to applications in analytical biosimilarity assessment. Keeping this in mind, this review aims at providing a holistic view of progresses in biosimilar analysis and approval. In this review, we have summarized the major developments in the global regulatory landscape with respect to biosimilar approvals and also catalogued biosimilarity assessment studies for recombinant DNA products available in the public domain. We have also covered recent advancements in analytical methods, orthogonal techniques, and platforms for biosimilar characterization, since 2015. The review specifically aims to serve as a comprehensive catalog for published biosimilarity assessment studies with details on analytical platform used and critical quality attributes (CQAs) covered for multiple biotherapeutic products. Through this compilation, the emergent evolution of techniques with respect to each CQA has also been charted and discussed. Lastly, the information resource of published biosimilarity assessment studies, created during literature search is anticipated to serve as a helpful reference for biopharmaceutical scientists and biosimilar developers.

Product Development of Sneakers Design Based on Consumer Preference Through Integration of Kano Method and Quality Function Deployment

Ardiles brand shoes are local Indonesian brand shoes that have been around since 1950. Ardiles produces several shoe models, one of which is sneakers. This brand received the top brand award from 2018 to 2021. In analyzing consumer needs, this study uses the Kano method and Quality Function Deployment (QFD). The attributes used to find 25 attributes based on 8 dimensions of product quality. The results of the research using the Kano category method were found that there are 2 attributes in the attractive category, 3 in the indifferent category, 3 in the must be category, and 17 in the one-dimensional category. Furthermore, the results of the QFD method get the top 5 attributes, namely shoes have two functions/models (low cut and high cut) with a value of 20.50%, shoe products have a warranty with a value of 13.87%, safe foot protection with a value of 9, 56%, eco print batik motifs with a value of 9.31%, and non-slip soles with a value of 6.39%. Efforts to improve with HOQ analysis obtained 16 technical requirements attributes with 5 highest priority including upper material type with a contribution value of 18.83%, outsole material type with a contribution value of 18.24%, locking system with a contribution value of 14.58 %, additional features with a contribution value of 13.28%, and the type of locking material with a contribution value of 8.54%.

Multi attribute method implementation using a High Resolution Mass Spectrometry platform: From sample preparation to batch analysis.

Quality control of biopharmaceuticals such as monoclonal antibodies (mAbs) has been evolving and becoming more challenging as the requirements of the regulatory agencies increase due to the demanding complexity of products under evaluation. Mass Spectrometry (MS)-based methods such as the multi-attribute method (MAM) are being explored to achieve a deeper understanding of the attributes critical for the safety, efficacy, and quality of these products. MAM uses high mass accuracy/high-resolution MS data that enables the direct and simultaneous monitoring of relevant product quality attributes (PQAs, in particular, chemical modifications) in a single workflow, replacing several orthogonal methods, reducing time and costs associated with these assays. Here we describe a MAM implementation process using a QTOF high resolution platform. Method implementation was accomplished using NIST (National Institute for Standards and Technology) mAb reference material and an in-process mAb sample. PQAs as glycosylation profiles, methionine oxidation, tryptophan dioxidation, asparagine deamidation, pyro-Glu at N-terminal and glycation were monitored. Focusing on applications that require batch analysis and high-throughput, sample preparation and LC-MS parameters troubleshooting are discussed. This MAM workflow was successfully explored as reference analytical tool for comprehensive characterization of a downstream processing (DSP) polishing platform and for a comparability study following technology transfer between different laboratories.