From Research to Release: Mapping Mabion’s Full Analytical Lifecycle for Monoclonal Antibodies 

• The entire analytical development cycle for monoclonal antibodies begins with early method development and molecular characterization of the product, through in-process control, to final quality control tests in the release testing phase. 
• Mabion aligns analytical development with process scale-up, uses advanced platforms for thorough characterization, and provides end-to-end services (including comparability studies, method validation, stability programs, and even clinical bioanalytics) under one roof. Each batch undergoes validated identity, potency, purity, and safety testing in GMP labs, ensuring compliance with ICH and pharmacopeial standards. 
• Mabion establishes Analytical Target Profiles for each method, defining sensitivity, range, and purpose, ensuring assays are fit-for-purpose approach and scientifically robust at every stage. 

What Does the Analytical Lifecycle of a Monoclonal Antibody Include?

The analytical lifecycle of a monoclonal antibody (mAb) encompasses all scientific activities designed to define, monitor, and guarantee product quality from discovery through commercial release. It is not a static sequence of assays but a dynamic, interconnected framework that evolves with the product as it advances through development.¹ It begins in early R&D with defining the molecule’s properties and setting up suitable analytical methods, and continues through process development with in-process controls, culminating in formal quality control for batch release. Industry and regulators alike emphasize that quality cannot be tested into a product at the end but must be designed, monitored, and confirmed throughout its lifecycle. This principle has driven the integration of advanced analytical technologies into every phase of mAb development and manufacturing, ensuring therapeutic consistency and patient safety.² 

Early analytical development and characterization 

The earliest stages of a monoclonal antibody’s journey focus on defining its molecular identity and establishing reliable assays to monitor its critical quality attributes (CQAs). CQAs are molecular and product features such as glycosylation profiles, aggregation levels, or binding potency that directly influence safety and efficacy. Identifying them early allows developers to design appropriate analytical methods that can consistently measure and control these parameters throughout the lifecycle.³ 

Mabion’s laboratories approach this step with a strong Quality by Design framework.⁴ Our scientists perform comprehensive molecular characterization using a suite of physicochemical and biological methods. 

Recent advances in analytical science have reinforced the importance of these early steps. For instance, state-of-the-art mass spectrometry platforms can now resolve glycan heterogeneity at unprecedented detail, which is essential because small glycan shifts can impact antibody half-life or effector functions.⁵ Similarly, innovations in capillary electrophoresis have enabled more sensitive detection of charge variants, which are key stability indicators.⁶ By integrating these techniques into early development, Mabion ensures that the analytical foundation of every mAb program is robust, reproducible, and aligned with regulatory expectations. 

In-process control 

As development progresses into manufacturing, attention shifts to real-time monitoring and control. Here, the goal is to ensure that the process consistently produces material within the specifications defined in early development. This involves monitoring critical process parameters (CPPs) such as pH, dissolved oxygen, and feed strategies in bioreactors, and linking them directly to CQAs like glycosylation or aggregation.⁷ 

In-process analytics verify that the process consistently produces material within predefined specifications, thereby supporting a validated, reproducible manufacturing process. 

QC Release Testing 

The culmination of the analytical lifecycle is quality control (QC) release testing, where each batch undergoes exhaustive evaluation before it can be released for clinical or commercial use. These tests are conducted in GMP-compliant laboratories with validated methods, ensuring compliance with international standards such as ICH Q6B and EMA/FDA guidelines. 

Recent studies highlight why such thorough testing is indispensable. Even subtle shifts in post-translational modifications or aggregation levels can significantly affect pharmacokinetics or immunogenicity, underscoring the need for high-resolution analytical methods.⁸ Mabion not only conducts these GMP release assays but also offers Qualified Person (QP) release services for EU markets, integrating the final regulatory check into its CDMO services portfolio. 

Early-Stage Analytical Development – Setting the Foundation for mAbs 

Early-stage analytical development lays the groundwork for a successful monoclonal antibody program. In this phase, scientists work to understand the mAb’s fundamental properties and to develop “fit-for-purpose” analytical methods that will be used to characterize the product and ensure quality as development proceeds. 

A crucial first step is defining the molecule’s Critical Quality Attributes (CQAs) – the molecular and product characteristics that must be controlled to guarantee the mAb’s safety and efficacy.⁹ Mabion begins by performing a CQA analysis, collaborating with the sponsor to identify which attributes (e.g. protein identity, glycosylation profile, aggregate levels, binding affinity) are most critical to monitor and control. 

Based on the defined CQAs and the stage of development, an Analytical Target Profile (ATP) is established for each method. The ATP is essentially a roadmap that spells out what each assay needs to measure and to what accuracy, serving as a design blueprint for method development.¹⁰ By setting clear targets (for example, an assay may need to quantify residual host-cell DNA down to a certain ppm level, or confirm potency within a defined range), Mabion ensures that the chosen analytical techniques are scientifically appropriate and will yield meaningful data for the molecule’s quality control. 

Mabion’s early-stage method development workflow exemplifies an emphasis on feasibility, precision, and breadth of application. The key elements include: 

1. CQA Identification: Pinpointing the mAb’s critical quality attributes to target. This guides which analytical methods are needed (for instance, if glycosylation is a CQA for an antibody’s efficacy, glycan profiling assays will be prioritized). 

2. Analytical Target Profile Definition: Outlining the purpose and performance requirements of each method (sensitivity, range, etc.), ensuring each assay is appropriate for its intended use – whether it’s measuring potency, purity, or stability. 

3. Fit-for-Purpose Method Design: Developing or optimizing assays so they are suitable for the specific product and stage. Methods are kept as simple and efficient as possible while still delivering high-quality data. For example, Mabion might employ a straightforward UV-Vis protein concentration test in early research, then refine to a more specific HPLC or ELISA quantitation as the program advances. 

4. Custom Assay Development (if needed): For unique analytical challenges, Mabion can design bespoke assays. If standard industry methods don’t adequately characterize an unusual mAb or novel format, their team will create tailored techniques to reliably measure those special attributes. This flexibility ensures feasibility – every critical attribute can be measured one way or another, even for complex or atypical molecules. 

5. Preliminary Qualification and System Suitability: Before formal validation, new methods undergo feasibility testing and preliminary validation. Mabion assesses parameters like accuracy, precision, linearity, and specificity on a small scale to confirm the method works as intended. They also build in System Suitability Tests (SSTs) – checks run with each analysis to make sure the instrument and assay are performing correctly (for example, running a standard sample to ensure an HPLC column’s resolution is acceptable before analyzing real samples). These early evaluations ensure the method produces reliable data from the beginning, giving confidence in its precision and consistency. 

6. Documentation and SOPs: Every method is documented in a Standard Operating Procedure (SOP) once optimized. Mabion prepares clear, step-by-step SOPs aligned with their Pharmaceutical Quality System, so that any trained analyst can reproduce the test and obtain consistent results. Meticulous documentation at this stage is critical for later transfer of the method into a regulated QC environment. 

During early development, extensive molecular characterization is also performed to establish the mAb’s profile. Mabion’s analytical labs use state-of-the-art techniques to probe the antibody’s structure and composition in detail. For example, we confirm the protein’s amino acid sequence and any post-translational modifications via peptide mapping and mass spectrometry. They analyze the antibody’s glycosylation profile – identifying attached sugar moieties, monosaccharide composition, sialic acid content, and glycation levels – using advanced HPLC and MS-based methods (HILIC-UPLC with fluorescent detection and LC-MS).¹¹ Higher-order structure is examined with techniques like circular dichroism (for secondary and tertiary structure confirmation), and disulfide bond mapping by MS ensures the antibody’s cysteine linkages are correctly paired. Physicochemical properties such as isoelectric point and charge variants are characterized using methods like capillary electrophoresis or ion-exchange chromatography, while aggregation is assessed via Size-Exclusion Chromatography (SEC) to detect any dimers or high molecular weight species.¹² Each of these tests builds a comprehensive understanding of the product. In addition, Mabion develops custom bioassays for functional testing, such as antibody-dependent cellular cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC) assays, ensuring that potency can be reliably quantified from the outset. 

Notably, if the program is a biosimilar mAb, early-stage analytics will include formal comparability exercises. Mabion can conduct head-to-head comparisons of the biosimilar candidate with the reference product, examining critical quality attributes such as glycosylation, potency, and Fc receptor binding side by side. By employing orthogonal physicochemical and biological assays, they ensure the biosimilar is “highly similar” to the original in all key respects, with any minor differences demonstrated not to affect clinical performance. These comparability studies generate data essential for regulatory submissions of biosimilars, and they underscore the precision and thoroughness of Mabion’s early analytical work in aligning a new product to an established standard.¹³ 

All the early development efforts set a strong foundation for later stages. Mabion’s approach ensures that by the time a monoclonal antibody moves toward manufacturing, validated analytical methods are in place or well on their way, and the molecule’s critical attributes are well understood. This foundation reduces risks downstream, as robust assays are available to monitor the mAb every step of the way. Importantly, Mabion proactively plans for the transition from development to manufacturing: all equipment used in the early development phase has an equivalent at manufacturing scale, and continuous knowledge transfer is arranged as the product moves from lab scale to mass production. By aligning methods and instruments early with what will be used in GMP production, they ensure a seamless scale-up – analytical methods don’t have to be reinvented later, and data generated at small scale remain relevant at larger scales. The outcome is an analytical toolkit that is feasible, precise, and comprehensive, ready to maintain control over the monoclonal antibody’s quality as the project advances. 

In-Process Control and Characterization During mAb Manufacturing 

Once the monoclonal antibody process enters manufacturing, rigorous in-process control analytics become vital to maintain product quality and yield. Biologic manufacturing is inherently variable. Living production systems (whether cell cultures or other expression platforms) can introduce fluctuations, so ongoing monitoring is needed to keep the process on target. In-process testing refers to analytical checks performed at various stages throughout production (upstream, purification, and formulation) to ensure each step is performing as expected and that the intermediate product meets predetermined criteria before moving forward. By integrating these tests into the manufacturing workflow, any deviations can be detected and corrected in real time, preventing small issues from compounding into batch failures. 

Crucially, all the analytical methods applied in process monitoring need to be suitable for a GMP environment. Many in-process tests are qualified (partially validated) methods and they have enough accuracy and precision to make decisions in-process, even if they are simpler or faster versions of the formal release assays. Mabion ensures that methods developed in R&D are successfully transferred and adapted to the manufacturing QC labs without loss of performance. Our scientists perform method transfers, gap analyses, and method adaptations so that by the time a process is in GMP manufacturing, its in-process tests run under the same rigor as any QC test. This seamless handoff is facilitated by their integrated teams: the same scientists who develop the assay in early phase can help implement it on the manufacturing floor, guaranteeing continuity. 

Mabion implements in-process control at multiple levels of its upstream and downstream operations. During upstream culture, automated analyzers and inline probes track nutrients, metabolites, and cell density, while spectroscopic tools such as Raman spectroscopy are increasingly used to infer metabolic state and even predict glycosylation outcomes in real time.¹⁴ In harvest and purification, Mabion applies rapid assays for host cell proteins (ELISA), host cell DNA (qPCR), and endotoxin (LAL methods), ensuring impurities remain within acceptable thresholds before moving forward. Chromatography steps are monitored using at-line HPLC and electrophoresis systems, enabling immediate feedback on purity and variant composition.¹⁵ 

Upstream Bioprocessing Monitoring 

In upstream bioprocessing, mAbs are produced by cultured cells (typically CHO cells) in bioreactors. Real-time monitoring of the bioreactor environment is crucial to ensure cells remain healthy and productive, and to steer the culture toward high titer and desired product quality. Standard bioreactor instruments continuously log CPPs such as temperature, pH, dissolved oxygen, and agitation rate. In addition, viable cell density and cell viability are tracked, often using dielectric spectroscopy probes or automated cell counters. Nutrient and metabolite levels (like glucose, glutamine, lactate, ammonia) are critical as well and their accumulation or depletion can significantly affect cell growth and mAb glycosylation patterns. Automated sampling devices combined with analyzers (e.g. blood gas analyzers or biochemical analyzers) provide at-line measurements of these metabolites.  

Perhaps even more impressively, upstream monitoring now extends to predicting product quality attributes before the product is even harvested. One important CQA for antibodies is the glycosylation profile, which can be influenced by culture conditions (nutrient levels, pH, temperature, etc.). Recent advances in data analytics and machine learning have enabled soft sensors that infer product quality from process data. It has been proven possible to develop machine learning models that can accurately predict the N-glycan profile of antibodies based on real-time measurements of nutrient intake in cell culture media. By analyzing daily media samples and cell consumption rates, that models identified key media components that correlate with high or low galactosylation and fucosylation levels on the antibody. This approach effectively allows manufacturers to monitor antibody glycan quality throughout the bioprocess without waiting for lengthy mass spectrometry assays.⁷ 

Harvest and Clarification Control 

After a suitable production time, the cell culture is harvested and the broth is clarified to remove cells and debris prior to chromatography. This harvest step itself is an opportunity for in-process monitoring and control. A common trigger for harvest in fed-batch processes is cell viability: as nutrients deplete and waste accumulates, viability drops and product quality can suffer (dead cells may release proteases and other contaminants). Bioreactors often have capacitance probes giving real-time viable cell volume, or at least daily off-line viability counts. Using these data, engineers can determine the optimal harvest time (e.g. when viability falls to ~80%) to maximize yield while avoiding degradation. 

In continuous perfusion processes, harvest is an ongoing operation where culture fluid is filtered out while cells are retained. Here, controlling the cell retention device (such as an alternating tangential flow filter) is critical. Typically, pressure sensors monitor filter fouling and adjust flow rates or initiate backflushing to prevent clogging. Turbidity or optical density sensors can also be installed on harvest output to detect the presence of cells or debris, ensuring the clarified fluid meets clarity specifications. If turbidity spikes (indicating cell breakthrough), the system can automatically divert the stream or adjust centrifuge settings. 

Beyond physical parameters, biochemical impurities are also monitored at harvest. Two key process-related impurities are host cell DNA and host cell proteins (HCPs), which regulatory guidelines require to be reduced to very low levels. While traditional testing for DNA and HCP is done off-line (e.g. qPCR for DNA, ELISA for HCP) on collected harvest samples, new approaches aim to measure these in real time.¹⁶ 

Notably, researchers have developed a continuous DNA sensor that can directly detect double-stranded DNA fragments in the harvest stream. This novel biosensor provides an immediate readout of DNA content as the culture is being clarified. In upstream application, a rising DNA signal can function as an early warning of cell lysis or reactor failure (since cells releasing DNA indicates a problem).¹⁷  

During harvest and clarification, the same sensor can confirm that cell lysis remains low and that DNA is being effectively removed by the centrifugation and filtration steps. Such real-time monitoring of DNA is a significant innovation, as DNA clearance historically could only be confirmed after the fact by laboratory tests. With an on-line DNA probe, the process could be adjusted on the fly – for example, extending a centrifugation step or adding a flocculant – if residual DNA is trending high. 

The harvest stage also includes any viral inactivation step (commonly a low-pH hold to inactivate viruses). Here, in-process control ensures the solution reaches the target pH and holds for the required time; pH meters and temperature probes monitor these conditions to comply with viral clearance requirements. Overall, by combining physical measurements (cell density, turbidity, pressure) with emerging biochemical sensors, the harvest and clarification process can be tightly controlled. This ensures a smooth transition to downstream purification, with a clarified harvest that consistently contains the expected mAb titer and impurity load, ready for the next purification steps. 

Downstream Bioprocessing Monitoring 

The downstream phase of mAb manufacturing involves several unit operations (chromatography steps, filtration steps) to purify the antibody and remove impurities. In traditional processes, downstream control relied on fixed recipes and extensive analysis of intermediate fractions. Today, there is a strong push toward real-time monitoring of downstream processes to achieve adaptive control and improved efficiency. 

A classic example is monitoring chromatography columns. Protein A affinity chromatography is usually the first capture step for mAbs; columns are equipped with UV absorbance detectors at the outlet to track protein binding and elution. The UV signal (at 280 nm for proteins) is used in-process to determine when the antibody is eluting so that fractions can be collected at the right time. In modern setups, these UV monitors are often supplemented with variable pathlength technology to accurately quantify high protein concentrations on-line. Additionally, multi-wavelength UV detectors can detect impurity peaks (for example, distinguishing DNA or aromatic compounds by their absorbance profile). Such monitors feed into automated control systems: if an unexpected peak is detected, the system might divert flow to waste or adjust the gradient. Another important attribute to watch is protein aggregation – the formation of antibody dimers or higher aggregates. Some processes now employ inline multi-angle light scattering (MALS) or dynamic light scattering detectors downstream of chromatography to estimate aggregate content of eluted pools. For instance, an SEC (size-exclusion chromatography) column can be coupled with a MALS detector in an at-line mode to measure aggregate percentage immediately after the protein A step, flagging any out-of-spec results before proceeding. 

One of the most significant advances in downstream monitoring is the advent of online chromatography analytics. Researchers recently demonstrated an ultra-fast online liquid chromatography (LC) system integrated into downstream processing, capable of monitoring product quality attributes in real time. By using short, optimized LC methods and dedicated instrumentation, they achieved sampling cycles of only ~1.5–2.5 minutes, fast enough to track the process continuously. This system was applied in several case studies across different purification steps. In two of the cases, the on-line LC could detect shifts in critical product attributes (such as the ratio of main product to variants or fragments) with high temporal resolution throughout the chromatography process. For example, during an anion-exchange polishing step, if a less charged variant of the antibody began to break through the column earlier than expected, the online LC immediately showed an increased signal for that variant, allowing operators to adjust the process or pooling strategy.¹⁸ 

In summary, in-process control and characterization during mAb manufacturing is about keeping a finger on the pulse of both the process and the product. Mabion’s comprehensive in-process analytics ensure that the monoclonal antibody is on-spec before it reaches final QC. This strategy not only safeguards quality in each batch but also provides a wealth of data for continuous improvement and validation, ultimately contributing to a more robust manufacturing process and consistent antibody product. 

Quality Control and Release Testing – Ensuring Batch Consistency 

After manufacturing is complete, each batch of monoclonal antibody must undergo thorough quality control (QC) and release testing. This final analytical phase is critical: it provides the evidence that the batch is consistent with all specifications and suitable for use. Release testing is performed in a regulated, GMP-compliant laboratory environment, using validated analytical methods, and it addresses every important quality attribute of the drug substance (bulk antibody) and drug product (formulated dose form). The goal is to ensure batch-to-batch consistency and verify that the product meets predefined standards for identity, purity, potency, safety, and other quality attributes, as set out in its regulatory filing. 

Mabion’s QC release platform includes identity confirmation by peptide mapping and electrophoretic profiling, potency assays using validated bioassays, purity assessments by SEC-HPLC and CE-SDS, and impurity testing for host cell proteins, DNA, and residual reagents.¹⁹ Safety-critical assays such as sterility, endotoxin, and mycoplasma detection are performed according to pharmacopeial requirements, with rapid qPCR-based methods supplementing traditional culture assays to accelerate turnaround. Stability-indicating assays, including particulate matter counts and accelerated degradation studies, ensure that the product remains within specification throughout its shelf life. 

Each of these tests is conducted according to validated methods that meet ICH guidelines for analytical procedure validation. Mabion’s validation practices confirm that the assays reliably and consistently measure their intended parameters, instilling confidence that QC results are trustworthy. For instance, the cell-based potency assay will have been validated to demonstrate it can repeatedly distinguish potent from sub-potent samples within a defined error margin.²⁰ The use of standards and controls in every run (as part of system suitability and method control) further ensures the data quality. In Mabion’s labs, all instruments and methods operate under a quality system that aligns with EU and US Pharmacopoeia standards and current good laboratory practice, reinforcing that release testing is done with the utmost rigor. 

Mabion’s Integrated Approach to Analytical Services for Monoclonal Antibodies 

Mabion Biologics distinguishes itself as a truly integrated end-to-end partner in the development of monoclonal antibodies, offering a one-stop suite of analytical and manufacturing services that span the entire product lifecycle. In practical terms, this means that the same organization (and often the same team of experts) that helps design an assay during early development can also carry that method through scale-up, validation, and eventual product release testing. This integrated model yields significant advantages for biotech clients: it reduces hand-offs between different vendors, preserves institutional knowledge about the product, and ensures a coherent quality philosophy from research through commercialization.²¹ Every stage of analytical work is aligned under Mabion’s quality system, which streamlines compliance and communication. 

Under Mabion’s integrated approach, there is seamless coordination between process development and analytical development.²² As described earlier, they deliberately mirror equipment and methodologies between the R&D lab and the manufacturing floor to enable smooth method transfer without loss of accuracy. When a method is ready to move from the development phase to routine use, Mabion’s team handles the transfer internally, avoiding the common pitfalls that occur when outsourcing analytics to separate labs. They custom-tailor transfer protocols and verify that a method performs equally well in the new setting, whether it’s moving into their GMP QC lab or even transferring from a client’s lab to Mabion. Because all analytical activities are under one roof, issues can be troubleshooted quickly – if a release assay shows an atypical result, the very scientists who developed the assay can investigate, leveraging their deep understanding of both the method and the molecule. This tight integration of expertise accelerates problem-solving and mitigates risk for project timelines.²³ 

From a quality and compliance perspective, Mabion’s integrated approach ensures uniformity in standards at every step. All analytical work is conducted under the umbrella of ICH guidelines and pharmacopeial standards, with a continuous focus on Quality by Design in method development.⁴ This means that whether a test is done for an early research sample or a commercial batch, the same rigor (appropriate to stage) is applied, and the data are managed within a single quality management system. Regulatory communication is also simplified: when filing an IND or BLA, data from various stages can be compiled with confidence that they were generated in a controlled environment. Mabion’s comprehensive documentation practices (from detailed validation reports to trend analysis and stability data) provide a traceable narrative of the product’s analytical lifecycle ready for regulator review. 

Conclusion 

Choosing Mabion as an analytical and manufacturing partner means entrusting your mAb to a fully integrated expert team committed to its success. The company’s investments in cutting-edge analytical platforms and its broad portfolio of methods (over 40 in-house techniques covering structural, physicochemical, and biological analyses) ensure that virtually any testing need can be met internally. This breadth not only speaks to technical capability but also to feasibility – whether your monoclonal antibody is a well-characterized IgG or an innovative format with unusual features, Mabion can likely accommodate its analytical demands without seeking external labs. The convenience of having development, GMP manufacturing, analytical testing, stability studies, and even regulatory consulting all available within one organization is a compelling model for biopharma companies looking to streamline their path from research to release. In essence, Mabion positions itself as an extension of your own team: an all-in-one biologics CDMO that is scientifically equipped and structurally organized to drive a monoclonal antibody from the early research bench, through clinical development, and on to a successful market launch. 

By mapping Mabion’s full analytical lifecycle for monoclonal antibodies, we see a blueprint of how comprehensive analytics underpin every milestone in a biologic’s journey. From initial CQA mapping and method development to real-time in-process controls and final GMP release assays, each phase is executed with scientific rigor and an eye toward the next step. Mabion’s integrated approach ensures continuity across these phases, maintaining quality and knowledge flow. For decision-makers in biologics development, this translates into reduced risk, improved efficiency, and confidence that the mAb’s critical attributes are managed expertly from research to release. The analytical lifecycle is a core enabler of successful antibodies development and with the right partner, it becomes a well-orchestrated process that accelerates innovation while safeguarding excellence at every turn. 

Prepared by:

Jakub Knurek

Marketing Specialist

j.knurek@mabion.eu

Jakub Knurek

Marketing Specialist

Jakub Knurek is a marketing and business development expert specializing in CDMO operations with scientific and biopharmaceutical background. During the COVID-19 pandemic, he contributed to the development of the Novavax protein vaccine. As a side project, he runs his own pharma company.

As the author of numerous articles, he is recognized as an important voice of the younger generation of scientists. He is a member of Mabion’s representation at industry trade shows, including BIO International Convention 2025 in Boston, 2nd Global Biologics India 2025 in Hydrabad, CPHI 2024 in Milan, CPHI 2023 in Barcelona, Life Sciences Baltics 2023 in Vilnius. He actively participates in academic, business and industry discussions, such as the “Building the Future Pharma Workforce” panel at CPHI Milan 2024.

References

1. Apostol I, Kelner DN. Managing the Analytical Lifecycle for Biotechnology Products : a journey from method development to validation. BioProcess International. 2008: 12-19. 
2. Rathore AS, Dash R. Late-Stage Failures of Monoclonal Antibodies. BioPharm International. 2022; 35(3): 14-16 
3. Ramos de la Peña AM, González-Valdez J, Aguilar O. Protein A chromatography: Challenges and progress in the purification of monoclonal antibodies. J Sep Sci. 2019; 42(9): 1816-1827. 
4. Wójcik-Bojek U. Enhancing biotechnological research with Design of Experiments. Mabion Science Hub. 2024. 
5. Potel CM, Burtscher ML, Garrido-Rodriguez M, Brauer-Nikonow A, Becher I, Le Sueur C, Typas A, Zimmermann M, Savitski MM. Uncovering protein glycosylation dynamics and heterogeneity using deep quantitative glycoprofiling (DQGlyco). Nat Struct Mol Biol. 2025; 32(6): 1111-1126. 
6. Wu Z, Wang H, Wu J, Huang Y, Zhao X, Nguyen JB, Rosconi MP, Pyles EA, Qiu H, Li N. High-sensitivity and high-resolution therapeutic antibody charge variant and impurity characterization by microfluidic native capillary electrophoresis-mass spectrometry. J Pharm Biomed Anal. 2023; 223: 115147. 
7. Lakshmanan M, Chia S, Pang KT, Sim LC, Teo G, Mak SY, Chen S, Lim HL, Lee AP, Bin Mahfut F, Ng SK, Yang Y, Soh A, Tan AH, Choo A, Ho YS, Nguyen-Khuong T, Walsh I. Antibody glycan quality predicted from CHO cell culture media markers and machine learning. Comput Struct Biotechnol J. 2024; 23: 2497-2506. 
8. Kuriakose A, Chirmule N, Nair P. Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications. J Immunol Res. 2016; 2016: 1298473. 
9. Alt N, Zhang TY, Motchnik P, Taticek R, Quarmby V, Schlothauer T, Beck H, Emrich T, Harris RJ. Determination of critical quality attributes for monoclonal antibodies using quality by design principles. Biologicals. 2016; 44(5): 291-305. 
10. Borman P, Campa C, Delpierre G, Hook E, Jackson P, Kelley W, Protz M, Vandeputte O. Selection of Analytical Technology and Development of Analytical Procedures Using the Analytical Target Profile. Anal Chem. 2022; 94(2): 559-570. 
11. Singh SK, Lee KH. Characterization of Monoclonal Antibody Glycan Heterogeneity Using Hydrophilic Interaction Liquid Chromatography-Mass Spectrometry. Front Bioeng Biotechnol. 2022; 9: 805788. 
12. Cernosek T, Dalphin M, Jain N, Richter N, Beard S, Wang J, Osborne J, Stone T, Mellal M, Behrens S, Wunderli P. Analytical Quality by Design as applied to the development of a SEC-HPLC platform procedure for the determination of monoclonal antibody purity without mobile phase additives. J Pharm Biomed Anal. 2024; 246: 116220. 
13. Ambrogelly A, Gozo S, Katiyar A, Dellatore S, Kune Y, Bhat R, Sun J, Li N, Wang D, Nowak C, Neill A, Ponniah G, King C, Mason B, Beck A, Liu H. Analytical comparability study of recombinant monoclonal antibody therapeutics. MAbs. 2018; 10(4): 513-538. 
14. Lykouras M, Papaspyridakou P, Makri OE, Georgakopoulos CD, Orkoula MG. Development of Analytical Method for the Quantitation of Monoclonal Antibodies Solutions via Raman Spectroscopy: The Case of Bevacizumab. Pharmaceuticals (Basel). 2024; 17(4): 446. 
15. Knurek J. In-Process Testing for Drugs in the Pharmaceutical Industry. Mabion Science Hub. 2025. 
16. Trzęsicka N. Qualitative analysis of Host Cell Proteins using mass spectrometry. Mabion Science Hub. 2025. 
17. Janssen SAJ, de Jong AM, Prins MWJ. Continuous monitoring of dsDNA fragments for biomanufacturing: Sensor development and feasibility study. Biosens Bioelectron. 2025; 288: 117808. 
18. Graf T, Naumann L, Bonnington L, Heckel J, Spensberger B, Klein S, Brey C, Nachtigall R, Mroz M, Hogg TV, McHardy C, Martinez A, Braaz R, Leiss M. Expediting online liquid chromatography for real-time monitoring of product attributes to advance process analytical technology in downstream processing of biopharmaceuticals. J Chromatogr A. 2024; 1729: 465013. 
19. Apostol I, Wu R, Ko M, Song JL, Li L, Schlobohm G, Szpankowski W. Prediction of Precision for Purity Methods. J Pharm Sci. 2020; 109(4): 1467-1472. 
20. Xu W, Bano N, Guzman-Valdes O, Amberman J, Bandlamudi E, Khanna P, Carmean R, Helmy R. Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody-Drug Conjugate. AAPS J. 2024; 26(3): 37. 
21. Torrente-López A, Hermosilla J, Salmerón-García A, Cabeza J, Navas N. Comprehensive Analysis of Nivolumab, A Therapeutic Anti-Pd-1 Monoclonal Antibody: Impact of Handling and Stress. Pharmaceutics. 2022; 14(4): 692. 
22. Knurek J. Antibodies Development Best Practices for CDMO Collaboration. Mabion Science Hub, 2025.