AAPS PharmSciTech最新文献

{"title":"Advances in Payload and Linker Designs for ADCs","authors":"Samson Gebretnsae","doi":"10.1208/s12249-026-03445-z","DOIUrl":"10.1208/s12249-026-03445-z","url":null,"abstract":"<p>Antibody-drug conjugates (ADCs) are a therapeutic approach that embodies the “magic bullet” concept envisioned by Paul Ehrlich. Since their initial clinical potential was recognized in the early 1980s, ADCs have undergone several generations of development to enhance their therapeutic index (Poon KA, et. al. 273(2):298-313, 2013). Recent advancements, particularly in the last third and the beginning of the fourth generation, have primarily focused on discovering new drug modalities and more potent cancer treatments, while also developing new linkers and improving site-specific and conjugation chemistries. The effectiveness and toxicity of ADCs are largely influenced by their overall physicochemical properties, especially hydrophobicity, plasma stability, resistance to payload release, and the efficient release of the payload at the target site (Saber H, et. al. 71(3):444-52, 2015), (Saber H, et. al. 107:104429, 2019). These properties are heavily dictated by the site of conjugation, conjugation chemistry, linkers, and payloads. Most payloads are hydrophobic and cannot undergo significant structural or functional changes without compromising their cytotoxicity. In contrast, linkers can be extensively modified to enhance the physicochemical characteristics of ADCs, improve stability, increase drug-to-antibody ratio (DAR), and reduce aggregation. This review will focus on the latest advancements in potent payloads with novel mechanisms of action, including immune-stimulating agents, protein degraders, radionuclides, light-activated photosensitizers for photoimmunotherapy, and dual-payload ADCs. Additionally, we will explore emerging linkers that offer varying stimuli for trigger payload release and improved release control.\u0000</p>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":5.1,"publicationDate":"2026-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1208/s12249-026-03445-z.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148262762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Twin-Screw Melt Granulation with Mannitol: High-Drug-Loaded Immediate-Release Tablets of Caffeine","authors":"Elzbieta Maria Buczkowska,&nbsp;Kirils Kukuls,&nbsp;Zoltán Márk Horváth,&nbsp;Alīna Jaroslava Frolova,&nbsp;Līga Pētersone,&nbsp;Suha Dadou,&nbsp;Valentyn Mohylyuk","doi":"10.1208/s12249-026-03464-w","DOIUrl":"10.1208/s12249-026-03464-w","url":null,"abstract":"<div><p>High drug-loaded immediate-release formulations can be produced using a solvent-free and continuous melt-granulation method with a twin-screw extruder. Known and widely used high-molecular-weight and hydrophobic melt-binders result in weak tablets and negatively influence the disintegration and dissolution of tablets. Thus, this work aimed to probe mannitol as a melt-binder at a concentration of 30 wt.% and to investigate the effect of twin-screw melt granulation processing temperature and screw speed on the preparation of high drug-loaded immediate-release caffeine tablets with superior mechanical properties. A two-level design of experiment with three center points was used for the screening of the effect of barrel temperature and screw speed on granules and tablets properties. Model drug caffeine was mixed with mannitol (Parteck® M100), while a Pharma 11 extruder with helix feed screw elements and without a nozzle was used for twin-screw melt granulation. Processing conditions were found to significantly influence the solid state of ingredients and the quality of granules. Mannitol, as a melt-binder at a concentration of 30 wt.% at given processing conditions, was proven as an efficient melt-binder for high drug-loaded immediate-release tablets with superior mechanical properties.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture><span>The alternative text for this image may have been generated using AI.</span></div></div></figure></div></div>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1208/s12249-026-03464-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148237229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Chloramphenicol Application Onto the Eyelid: Transfersomes for Enhanced Skin Delivery","authors":"Larysa Grygor’yeva,&nbsp;Manuela Colla Carvalheiro,&nbsp;Joana Marto,&nbsp;Sandra Simões","doi":"10.1208/s12249-026-03481-9","DOIUrl":"10.1208/s12249-026-03481-9","url":null,"abstract":"<div><p>The aim of the study was to prepare chloramphenicol (CAM)-loaded transfersomes to enhance drug permeability following topical administration, considering the final goal of treating conjunctivitis by applying the formulation onto the eyelid. The CAM-loaded transfersomes obtained have an average particle size of approximately 120 nm, are monodispersed with polydispersity index &lt; 0.1, and exhibit high encapsulation efficiency (84 ± 5.5%). The formulation showed vesicle deformability, good biocompatibility and enhanced skin permeation compared to a conventional ophthalmic formulation of the antibiotic. The optimized drug-loaded nanosystem was subsequently jellified and the fluid gel obtained presented rheological behaviour adequate for application onto the eyelid. The formulation showed physical and chemical stability after 3 months storage. Therefore, eyelid administration of CAM-loaded transfersomes could be considered as a potential strategy for the treatment of bacterial conjunctivitis.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture><span>The alternative text for this image may have been generated using AI.</span></div></div></figure></div></div>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1208/s12249-026-03481-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148222416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Carbohydrate-Functionalized Liposomal Nanocarriers: Design Strategies for Receptor-Mediated Organ Targeting and Advanced Theranostic Applications","authors":"Jayaraj Beliraya,&nbsp;Raagul Seenivasan,&nbsp;Praveen Halagali,&nbsp;Mahalaxmi Rathnanand,&nbsp;Vamshi Krishna Tippavajhala","doi":"10.1208/s12249-026-03483-7","DOIUrl":"10.1208/s12249-026-03483-7","url":null,"abstract":"","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1208/s12249-026-03483-7.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148222381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of Resveratrol/Curcumin Dual-Loaded Chitosan/Sericin Hydrogel Films for Wound Healing: A Comparison Of Shrimp- and Crab-Sourced Chitosan","authors":"Bui Thi Phuong Thuy,&nbsp;Phuong T. M. Ha,&nbsp;Nguyen Thi Ngoc Quyen,&nbsp;Nguyen Thi Kim Ngan,&nbsp;Ngoc Yen Nguyen,&nbsp;Nguyen Trong Tuan,&nbsp;Huynh Vu Thanh Luong,&nbsp;Tran Thi Bich Quyen,&nbsp;Trieu Phu Hau,&nbsp;Duy Toan Pham","doi":"10.1208/s12249-026-03475-7","DOIUrl":"10.1208/s12249-026-03475-7","url":null,"abstract":"<div><p>This study reports the formulation and comparative evaluation of resveratrol and curcumin dual-loaded chitosan-based wound-healing films prepared from shrimp-derived chitosan (Shrimp-CTS, ~ 80 kDa, degree of deacetylation of ~ 95%) and crab-derived chitosan (Crab-CTS, ~ 100 kDa, degree of deacetylation of ~ 85%). The film was prepared by crosslinking reaction of chitosan and glutaraldehyde, and the influence of chitosan origin on film structure, swelling, drug release, skin permeability, and <i>in vivo</i> wound healing was investigated. Morphological analyses revealed that shrimp-CTS-films possessed heterogeneous surfaces, whereas crab-CTS-films exhibited smoother surfaces. Swelling studies showed that shrimp-CTS-films displayed a burst swelling, reaching 75–85% swelling within 30–60 min, while the crab-CTS-films exhibited sustained swelling, progressively increasing to ~ 100% after 240 min. All drug release profiles followed biphasic kinetics (a burst release phase and a sustained phase) and fitted well to the Korsmeyer-Peppas model (R² &gt; 0.90), suggesting anomalous transport governed by combined diffusion (mainly for shrimp-CTS) and polymer relaxation (mainly for crab-CTS). <i>Ex vivo</i> porcine skin studies confirmed superior permeability from crab-CTS-films, with cumulative permeation values approaching 85–100% at 300 min, compared to 50–80% for shrimp-CTS-films. Lastly, <i>in vivo</i> murine excisional wound models demonstrated that all films showed better healing performances than the commercial product (OctaCare®). Interestingly, the dual-loaded shrimp-CTS-films accelerated early wound closure to ~ 65–70% by day 3 and &gt; 90% by day 7, whereas the dual-loaded crab-CTS-films promoted more consistent healing, achieving ~ 95–100% wound closure by days 14–21. In summary, these results demonstrate that chitosan sources affect the films’ physicochemical properties, especially the phase-specific wound-healing outcomes.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture><span>The alternative text for this image may have been generated using AI.</span></div></div></figure></div></div>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148215890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Process Development of Site-Specific Antibody–Drug Conjugates","authors":"Brian O’Mara,&nbsp;Shantanu Guha","doi":"10.1208/s12249-026-03456-w","DOIUrl":"10.1208/s12249-026-03456-w","url":null,"abstract":"<div><p>Antibody–drug conjugates (ADCs) combine the targeting specificity of monoclonal antibodies with cytotoxic small-molecule payloads, enabling selective delivery of highly potent therapeutics. As the field has advanced, conjugation strategy has become a primary driver of product quality, manufacturability, and development risk. Site-specific approaches include engineered cysteine residues, non-canonical amino acid (ncAA) incorporation, and enzyme-mediated conjugation. These platforms enable defined drug-to-antibody ratios (DAR) and improved product homogeneity, shifting control to molecular design and necessitating integrated process strategies across upstream, downstream, and conjugation to ensure consistent execution at scale. This chapter presents a practical framework for the process development and characterization of site-specific ADCs across the development lifecycle. Upstream, recovery, downstream, conjugation, and post-conjugation purification are treated as an integrated system, where variability at each stage has the potential to influence performance and quality of the final drug substance conjugate. Analytical strategies applied across these stages provide the link between process parameters and critical quality attributes, including DAR distribution, aggregation, and residual impurities. The transition from early-phase to late-stage development is considered in the context of increasing process understanding, definition of control strategies, and regulatory expectations. Considerations for process intensification, advanced analytics, and process analytical technologies (PAT) are also discussed, with emphasis on how early development decisions and process knowledge define commercial manufacturing strategy and execution.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture><span>The alternative text for this image may have been generated using AI.</span></div></div></figure></div></div>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148209682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Amphotericin B-cholesterol Co-encapsulated Polymeric Nanoparticles in Protein Hydrogel-based Injectable Depot System for Long-acting Drug Delivery","authors":"Sanat Kumar Dash,&nbsp;Rashmi Ghosh,&nbsp;Anil B. Jindal","doi":"10.1208/s12249-026-03447-x","DOIUrl":"10.1208/s12249-026-03447-x","url":null,"abstract":"<div><p>Amphotericin B exhibits dose-dependent nephrotoxicity and hepatotoxicity due to its non-selective interaction with mammalian cholesterol. The aim of the present study was to develop an Amphotericin B-cholesterol co-encapsulated albumin hydrogel-based injectable depot formulation to achieve prolonged plasma drug concentrations with reduced toxicity. Amphotericin B-loaded polymeric nanoparticles (Amphotericin B-PNs) were prepared by the nanoprecipitation method. Cholesterol co-encapsulated nanoformulation has been able to keep Amphotericin B in a less aggregated state (aggregation ratio -1.40), exhibited less hemolysis (&lt; 10%) in rat erythrocytes, higher cytocompatibility in HEK 293 T and RAW 264.7 cell lines, as well as time-dependent increased intracellular accumulation of C6 loaded nanoparticles. Amphotericin B-PN-loaded albumin hydrogel was prepared by an ethanol-induced gelation process. Nanoparticle-loaded hydrogel exhibited sustained drug release, and at the end of one week ~ 60% of Amphotericin B was released. Hydrogel formulations have shown improved pharmacokinetic parameters with prolonged drug release till the end of the 14th day. The cholesterol co-encapsulated hydrogel has also shown reduced organ toxicity and improved safety against oxidative stress, as revealed by biochemical (creatinine, BUN, ALT, and AST) and ROS (GSH, catalase, NO, and MDA) scavenging assays. Overall, it can be concluded that the Amphotericin B-PN-loaded albumin hydrogel could be a potential delivery system for the long-acting release of Amphotericin B with reduced toxicity.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture><span>The alternative text for this image may have been generated using AI.</span></div></div></figure></div></div>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148209701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oil-in-water Emulsion as a Strategy for Taste Masking of Cannabinoid Extract","authors":"Juliana Feitoza Brasil,&nbsp;Luiza Aparecida Luna Silvério,&nbsp;Claudete da Costa-Oliveira,&nbsp;Leonardo Costalonga Rodrigues,&nbsp;Maria Helena Gonçalves,&nbsp;Leonardo Mathias Leidens,&nbsp;Carla Daniela Boeira,&nbsp;Jose Luiz Costa,&nbsp;Antonio Riul Junior,&nbsp;Priscila Gava Mazzola","doi":"10.1208/s12249-026-03472-w","DOIUrl":"10.1208/s12249-026-03472-w","url":null,"abstract":"<div><p>Organoleptic properties are important factors in the development of pharmaceutical formulations, as they directly impact patient adherence and, consequently, treatment efficacy. Cannabinoid-based oils often possess unpleasant taste and texture, which can compromise treatment compliance. This preliminary proof-of-concept study aimed to develop oil-in-water (O/W) emulsions utilizing cannabidiol (CBD) and cannabigerol (CBG) rich extracts, evaluate their physicochemical stability under accelerated conditions, and perform an instrumental taste-related characterization. The formulations exhibited pH values of 6.5 ± 0.2 for the CBD-based emulsion and 6.6 ± 0.2 to CBG- for the CBG-based emulsion, with no significant weight loss observed. Although a decrease in viscosity and active content was observed over 6 months, particularly in the CBD-rich emulsion (over 50%), these effects can be mitigated by increasing antioxidant and ionic emulsifying agent concentrations. LUMiSizer analysis demonstrated that the presence of the extracts enhanced emulsion stability compared to blank formulations, yielding instability indexes of 0.237 ± 0.011 (CBD), 0.282 ± 0.010 (CBG), and 0.312 ± 0.011 (blank). Preliminary instrumental taste profiling using an electronic tongue (e-tongue) showed that the emulsions generated fingerprints indistinguishable from the blank formulation and clearly distinct from a bitter reference. Overall, these results provide preliminary evidence supporting the use of O/W emulsions as a taste-masking strategy for cannabinoid delivery. While the e-tongue data demonstrated effective instrumental masking of bitterness, the physicochemical stability data revealed limitations that must be addressed in future formulation iterations, particularly regarding CBD content and long-term phase stability.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture><span>The alternative text for this image may have been generated using AI.</span></div></div></figure></div></div>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1208/s12249-026-03472-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148209711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Solvent‑Free Bioerodible Ophthalmic Inserts for Mangiferin Delivery: Physicochemical Characterization and In Vivo Evaluation","authors":"Nam V. Dao,&nbsp;Tu V. Le,&nbsp;Anh Q. Vo","doi":"10.1208/s12249-026-03465-9","DOIUrl":"10.1208/s12249-026-03465-9","url":null,"abstract":"<div><p>Ophthalmic topical dosage forms are often limited by their low bioavailability, primarily due to rapid precorneal clearance. Prolonging the precorneal residence time enables sufficient drug absorption and facilitates the desired pharmacological effects. In this study, mangiferin-loaded ophthalmic inserts were successfully formulated using hydroxypropyl methylcellulose acetate succinate (HPMC AS) as a matrix-forming agent via the hot-melt extrusion technique. The prepared inserts were systematically characterized with respect to morphology, drug-polymer interaction, drug polymorphism, drug content, surface pH, and drug release. A correlation between independent factors and drug release <i>in vitro</i> was established, enabling the customization of drug release profiles. The <i>in vivo</i> study exhibited that the formulation was well tolerant to the rabbit eyes and remained in the lower conjunctival cul-de-sac for over 12 h. Furthermore, the concentration of mangiferin in the lacrimal fluid remained relatively consistent for up to 12 h, thereby allowing sustained exposure of the cornea-conjunctiva surface—the target site of action—to drug therapeutic levels. These findings suggest that the developed ophthalmic inserts offer a promising strategy for the ocular delivery of mangiferin in the treatment of herpes keratitis.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture><span>The alternative text for this image may have been generated using AI.</span></div></div></figure></div></div>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148209759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rapid Identification of Counterfeit Biopharmaceuticals using Portable Fourier Transform Infrared Spectroscopy","authors":"Vineela Peruri,&nbsp;Rishika Trivedi,&nbsp;Drashti Trivedi,&nbsp;Arunima Garg,&nbsp;Anurag S. Rathore","doi":"10.1208/s12249-026-03477-5","DOIUrl":"10.1208/s12249-026-03477-5","url":null,"abstract":"<div><p>Biopharmaceuticals are expensive due to their sophisticated manufacturing processes, challenges in analytical characterization, and stringent storage and transportation conditions. Due to the high cost and increasing demand, they have emerged as a desirable target for counterfeiters. Challenges in the identification of counterfeits originate from the fact that biological products are extremely complex, requiring complex analytical tools and tedious sample preparations. These sophisticated techniques and operational expertise are not available in all regions of low-income nations, hence exacerbating the incidence of counterfeit pharmaceuticals. This study proposes a simple FTIR spectroscopy method to rapidly identify counterfeits from original biopharmaceuticals. The dataset comprises curated FTIR spectra from 43 monoclonal antibodies(mAbs) and 42 non-mAb products., pre-processed for noise reduction and baseline correction. The study was structured into three case studies: (1) Assessing biosimilarity, (2) Detection of counterfeits, and (3) Detection of products with compromised potency. The proposed method reliably identified deviations in both mAbs and non-mAb therapeutics. Biosimilars that were outliers in PCA score plots were flagged as counterfeits across multiple analytical approaches, and mAbs diluted to 70% concentration were effectively distinguished using PCA and K-means clustering. Counterfeit detection was validated by RP-HPLC analysis. This integrated pipeline offers a rapid, label-free, and non-destructive solution for ensuring product integrity in biopharmaceutical manufacturing and distribution. These findings underscore that Fourier-Transform Infrared (FTIR) spectroscopy, paired with statistical and machine learning approaches, can be used for rapid, easy, real-world counterfeit detection and quality assurance of biopharmaceuticals.</p><h3>Graphical Abstract</h3>\u0000<div><figure><div><div><picture><source><img></source></picture><span>The alternative text for this image may have been generated using AI.</span></div></div></figure></div></div>","PeriodicalId":6925,"journal":{"name":"AAPS PharmSciTech","volume":"27 5","pages":""},"PeriodicalIF":4.0,"publicationDate":"2026-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148209778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}