Biochemical Engineering Journal, Год журнала: 2023, Номер 203, С. 109188 - 109188
Опубликована: Дек. 21, 2023
Язык: Английский
Pharmaceuticals, Год журнала: 2024, Номер 17(2), С. 235 - 235
Опубликована: Фев. 11, 2024
Biological therapies have transformed high-burden treatments. As the patent and exclusivity period for biological medicines draws to a close, there is possibility development authorization of biosimilars. These products boast comparable levels safety, quality, effectiveness their precursor reference products. Biosimilars, although similar products, are not identical copies should be considered generic substitutes original. Their evaluation involve rigorous step-by-step process that includes analytical, functional, nonclinical evaluations clinical trials. Clinical studies conducted biosimilars aim establish efficacy, immunogenicity, rather than demonstrating benefit, as with product. However, current knowledge regarding has significantly increased, several controversies misconceptions still exist extrapolation, interchangeability, substitution, nomenclature. The stimulates market competition, contributes toward healthcare sustainability, allows greater patient access. maximizing benefits requires cooperation between regulators developers ensure patients can benefit quickly from access these new therapeutic alternatives while maintaining high standards efficacy. Recognizing inherent complexities comprehending fully, it essential focus on realistic approaches, such fostering open communication providers patients, encouraging informed decision-making, minimizing risks. This review addresses regulatory manufacturing requirements provides clinicians relevant insights prescribing.
Язык: Английский
Процитировано
22
Mass Spectrometry Reviews, Год журнала: 2023, Номер 43(3), С. 560 - 609
Опубликована: Июль 28, 2023
Abstract The role of mass spectrometry (MS) has become more important in most application domains recent years. Pharmaceutical analysis is specific due to its stringent regulation procedures, the need for good laboratory/manufacturing practices, and a large number routine quality control analyses be carried out. MS is, therefore, very different throughout whole drug development cycle. While it dominates within discovery phase, control, minor indispensable only selected applications. Moreover, case small molecule pharmaceuticals biopharmaceuticals. Our review explains current both small‐molecule chemical drugs Important features MS‐based technologies being implemented, method requirements, related challenges are discussed. differences analytical procedures biopharmaceuticals pointed single or set methods usually sufficient often not indispensable, panel including extensive use must used Finally, expected future trends outlined.
Язык: Английский
Процитировано
20
Electrophoresis, Год журнала: 2023, Номер 45(1-2), С. 165 - 198
Опубликована: Сен. 5, 2023
Abstract This review article brings a comprehensive survey of developments and applications high‐performance capillary microchip electromigration methods (zone electrophoresis in free solution or sieving media, isotachophoresis, isoelectric focusing, affinity electrophoresis, electrokinetic chromatography, electrochromatography) for analysis, micropreparation, physicochemical characterization peptides the period from 2021 up to ca. middle 2023. Progress study properties various aspects their such as sample preparation, adsorption suppression, electroosmotic flow regulation, detection, are presented. New particular demonstrated, several types reported. They cover qualitative quantitative analysis synthetic isolated determination complex biomatrices, peptide profiling biofluids tissues, monitoring chemical enzymatic reactions changes peptides. include also amino acid sequence peptides, mapping proteins, separation stereoisomers chiral analyses. In addition, micropreparative separations interactions with other (bio)molecules by above CE described.
Язык: Английский
Процитировано
17
Nature Reviews Nephrology, Год журнала: 2024, Номер 20(10), С. 672 - 689
Опубликована: Июль 3, 2024
Язык: Английский
Процитировано
8
Journal of the American Society for Mass Spectrometry, Год журнала: 2024, Номер 35(2), С. 333 - 343
Опубликована: Янв. 29, 2024
High confidence and reproducibility are still challenges in bottom-up mass spectrometric N-glycopeptide identification. The collision energy used the MS/MS measurements database search engine to identify species perhaps two most decisive factors. We investigated how structural features of N-glycopeptides choice influence optimal energy, delivering highest identification confidence. carried out LC-MS/MS using a series energies on large set with both glycan peptide part varied studied behavior Byonic, pGlyco, GlycoQuest scores. found that engines show range between peptide-centric glycan-centric, which manifests itself already dependence m/z. Using classical statistical machine learning methods, we revealed hydrophobicity, masses, number mobile protons also have significant search-engine-dependent influence, as opposed other parameters probed. envisioned an workflow making smart based online available such hydrophobicity (described by retention time) (potentially from scout MS/MS). Our assessment suggests this can lead gain (up 100%) confidence, particularly for low-scoring hits close filtering limit, has potential enhance analyses. Data via MassIVE (MSV000093110).
Язык: Английский
Процитировано
6
Journal of Separation Science, Год журнала: 2024, Номер 47(9-10)
Опубликована: Май 1, 2024
Saccharides and biocompounds as saccharide (sugar) complexes have various roles biological functions in living organisms due to modifications via nucleophilic substitution, polymerization, complex formation reactions. Mostly, mono‐, di‐, oligo‐, polysaccharides are stabilized inactive glycosides, which formed metabolic pathways. Natural saccharides important food environmental monitoring. Glycosides with functionalities significant clinical medical research. often studied the chromatographic methods of hydrophilic interaction liquid chromatography anion exchange chromatograpy, but also capillary electrophoresis mass spectrometry their on‐line coupling systems. Sample preparation is identification compounds. The cases discussed here focus on bioscience, clinical, applications.
Язык: Английский
Процитировано
5
TrAC Trends in Analytical Chemistry, Год журнала: 2023, Номер 160, С. 116975 - 116975
Опубликована: Фев. 10, 2023
The biopharmaceutical market is one of the fastest growing biotechnology markets. In order to ensure affordable and reliable therapeutics, process has be closely monitored. Capillary electrophoresis (CE) proven a valuable technique for analysis product concentration, critical quality attributes, process-related impurities, nutrients metabolites in cell culture medium. zone electrophoresis, capillary gel isoelectric focusing are extensively used size or charge heterogeneity determination. CE number benefits upstream downstream process-intermediates, including ability handle highly complex matrices found high resolving power, little sample preparation requirements, rapid analysis, low solvent consumption. small volumes (nL range) especially beneficial microbioreactor clone selection experiments. simple setup possibility miniaturisation automation using microchip provides great opportunities on-site, real-time monitoring process. This review discusses applications processing last decade.
Язык: Английский
Процитировано
12
Analytical Chemistry, Год журнала: 2023, Номер 95(21), С. 8299 - 8309
Опубликована: Май 18, 2023
Aggregation of monoclonal antibody therapeutics is a serious concern that believed to impact product safety and efficacy. There need for analytical approaches enable rapid estimation mAb aggregates. Dynamic light scattering (DLS) well-established technique estimating the average size protein aggregates or evaluating sample stability. It usually used measure distribution over wide range nano- micro-sized particles using time-dependent fluctuations in intensity scattered arising from Brownian motion particles. In this study, we present novel DLS-based approach allows us quantify relative percentage multimers (monomer, dimer, trimer, tetramer) (mAb) therapeutic product. The proposed uses machine learning (ML) algorithm regression model system predict amount relevant species such as monomer, tetramer 10–100 nm. DLS-ML compares favorably all potential alternatives with respect key method attributes, including per cost analysis, time data acquisition along ML-based aggregate prediction (<2 min), requirements (<3 μg), user-friendliness analysis. can serve an orthogonal tool exclusion chromatography, which current industry workhorse assessment.
Язык: Английский
Процитировано
11
Applied Microbiology and Biotechnology, Год журнала: 2025, Номер 109(1)
Опубликована: Янв. 22, 2025
Monoclonal antibodies are extensively used as biotherapeutics for treatment of a variety diseases. Glycosylation therapeutic is considered critical quality attribute it influences the effector function, circulatory half-life, immunogenicity, and eventually efficacy patient safety. During upstream process development, media components play significant role in determining glycosylation profile. In this study, we have evaluated 20 additives (metal ions, vitamins, sugars, nucleosides). Six were shortlisted their impact then to modulate profile an in-house produced mAb (G0 2.38 ± 0.08%, G0F 75.58 0.45%, G1F 10.07 0.04%, G2F 0.54 0.01%, G0F-N 5.84 0.32%, sialylation 1.60 0.33%, mannosylation 1.56 0.39%) achieve glycan commercially available reference product 2.49 0.07%, 37.83 0.37%, 34.77 0.03%, 4.87 2.34 0.12%, 9.84 0.30%, 2.86 0.29%). The proposed approach yielded us 2.10 38.00 0.49%, 31.92 0.09%, 5.26 0.54%, 1.92 0.02%, 10.28 1.68%, 3.12 0.29%) that was near identical product. Equally importantly, other attributes including charge variants, aggregates, titer, viability not found be significantly impacted by addition under consideration. • Screened evaluate effect on mAbs. Developed indices models various additives. Additive concentrations optimized target
Язык: Английский
Процитировано
0
BioDrugs, Год журнала: 2025, Номер unknown
Опубликована: Янв. 28, 2025
Язык: Английский
Процитировано
0