Stabilization challenges and aggregation in protein-based therapeutics in the pharmaceutical industry

Mahdie Rahban, Faizan Ahmad, Mieczyslaw A. Piatyszek, Thomas Haertlé, Luciano Saso and Ali Akbar Saboury

RSC Adv., 2023, 13, 35947
DOI: 10.1039/D3RA06476J

Design of self-assembled glycopolymeric zwitterionic micelles as removable protein stabilizing agents

Robin Rajan and Kazuaki Matsumura

Nanoscale Adv., 2023, 5, 1767
DOI: 10.1039/D3NA00002H

Vasoactive intestinal peptide amphiphile micelle material properties influence their cell association and internalization

Xiaofei Wang, Agustin T. Barcellona, Fateme Nowruzi, Kambrie M. Brandt, Megan C. Schulte, Luke E. Kruse, Eric Dong, Adam G. Schrum, Esma S. Yolcu and Bret D. Ulery

Mol. Syst. Des. Eng., 2025, 10, 534
DOI: 10.1039/D4ME00167B

Strategies for overcoming protein and peptide instability in biodegradable drug delivery systems

Miusi Shi and Kevin J. McHugh

Advanced Drug Delivery Reviews, 2023, 199, 114904
DOI: 10.1016/j.addr.2023.114904

Computational investigation of antiviral peptide interactions with Mpox DNA polymerase

Harshit Tiwari, Ashal Ilyas, Pankaj Kumar Rai, Shashank Upadhyay and Subhomoi Borkotoky

In Silico Pharmacol., 2025, 13
DOI: 10.1007/s40203-025-00342-4

Enhanced and Prolonged Immunogenicity in Mice of Thermally Stabilized Fatty Acid-Conjugated Vaccine Antigen

Bo Mi Kim, Yeon-Ho Kim, Hai V. Ngo, Hy D. Nguyen, Chulhun Park and Beom-Jin Lee

Vaccines, 2025, 13, 168
DOI: 10.3390/vaccines13020168

The Application of Nano Drug Delivery Systems in Female Upper Genital Tract Disorders

Daniélle van Staden, Minja Gerber and Hendrik J. R. Lemmer

Pharmaceutics, 2024, 16, 1475
DOI: 10.3390/pharmaceutics16111475

Amphiphilic albumin-based nanoparticles designed for the efficient delivery of taxanes

Guojun Xiong, Shengxi Li, Andreas G. Schätzlein and Ijeoma F. Uchegbu

International Journal of Pharmaceutics, 2025, 682, 125965
DOI: 10.1016/j.ijpharm.2025.125965

Protein‐based Nanoparticles: From Drug Delivery to Imaging, Nanocatalysis and Protein Therapy

Jonas Kaltbeitzel and Peter R. Wich

Angew Chem Int Ed, 2023, 62
DOI: 10.1002/anie.202216097

Enrichment strategy and initial characterization of heterodimers enriched from a co-formulated cocktail of therapeutic antibodies against SARS-COV-2

Sophia Liu, Yuetian Yan, Cody M. Secor, Zachary R. Oberholtzer, Donna J. Skow, Mushhood Sheikh, Youmi Moon, Yue Fu, Cristinel Sandu, Shunhai Wang, Ning Li, Jennifer B. Nguyen, Michael P. Rosconi and Erica A. Pyles

mAbs, 2024, 16
DOI: 10.1080/19420862.2024.2338301

Influence of pneumatic transportation on the stability of monoclonal antibodies

Pierre Coliat, Stéphane Erb, Hélène Diemer, Dan Karouby, Tristan Martin, Mainak Banerjee, Chen Zhu, Martin Demarchi, Sarah Cianférani, Alexandre Detappe and Xavier Pivot

Sci Rep, 2023, 13
DOI: 10.1038/s41598-023-49235-6

A Review of Recent Developments in Biopolymer Nano-Based Drug Delivery Systems with Antioxidative Properties: Insights into the Last Five Years

Magdalena Stevanović and Nenad Filipović

Pharmaceutics, 2024, 16, 670
DOI: 10.3390/pharmaceutics16050670

Conjugation Chemistry Markedly Impacts Toxicity and Biodistribution of Targeted Nanoparticles, Mediated by Complement Activation

Michael H. Zaleski, Liam S. Chase, Elizabeth D. Hood, Zhicheng Wang, Jia Nong, Carolann L. Espy, Marco E. Zamora, Jichuan Wu, Lianne J. Morrell, Vladimir R. Muzykantov, Jacob W. Myerson and Jacob S. Brenner

Advanced Materials, 2025, 37
DOI: 10.1002/adma.202409945

Preventing Protein Self‐Association Through Strategic Covalent Modification

Swetha Chintala and Simon H. Friedman

Journal of Peptide Science, 2025, 31
DOI: 10.1002/psc.70008

Characterizing Silicone Oil-Induced Protein Aggregation with Stimulated Raman Scattering Imaging

Brian Wong, Xi Zhao, Yongchao Su, Hanlin Ouyang, Timothy Rhodes, Wei Xu, Hanmi Xi and Dan Fu

Mol. Pharmaceutics, 2023, 20, 4268
DOI: 10.1021/acs.molpharmaceut.3c00391

Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs

Kang Chen and Cameron J. Smith

AAPS J, 2023, 25
DOI: 10.1208/s12248-023-00782-w

Immunogenicity of Therapeutic Antibodies Used for Inflammatory Bowel Disease: Treatment and Clinical Considerations

Ole Haagen Nielsen, Alexander Hammerhøj, Mark Andrew Ainsworth, John Gubatan and Geert D’Haens

Drugs, 2025, 85, 67
DOI: 10.1007/s40265-024-02115-3

Avidity-Based Detection and Quantification of Igg Aggregates Using a Nanoplasmonic Fiber Optical Biosensor System

Thuy Thi Tran, Erik Martinsson, Sergio Vargas, Ingemar Lundström, Carl-Fredrik Mandenius and Daniel Aili

SSRN Journal, 2022
DOI: 10.2139/ssrn.4116189

Machine-guided dual-objective protein engineering for deimmunization and therapeutic functions

Eric Wolfsberg, Jean-Sebastien Paul, Josh Tycko, Binbin Chen, Michael C. Bassik, Lacramioara Bintu, Ash A. Alizadeh and Xiaojing J. Gao

Cell Systems, 2025, 16, 101299
DOI: 10.1016/j.cels.2025.101299

Recent research on the druggability properties of chemical modification of endogenous substances

Tao Yuan, Sulong Xiao and Demin Zhou

Sci. Sin.-Chim, 2025, 55, 2452
DOI: 10.1360/SSC-2025-0168

Strategies to Overcome Undesired Physicochemical Changes in Particle Engineering for Inhalation

Mariana Romero-Gonzalez, Julia Crowther, Mani Ordoubadi and Ashlee D. Brunaugh

KONA, 2025, 42, 121
DOI: 10.14356/kona.2025008

Harnessing the potential of 2-methyl imidazolium dihydrogen phosphate as a protein stabilizer: Assessing its toxicity and impact on aggregation, structural integrity, and functional efficacy of monoclonal antibodies

Radhika Pachpore, Shailesh Dugam, Triveni Manchekar, Bhalchandra Kulkarni, Dhanashree Jagtap, Prajakta Dandekar and Ratnesh Jain

Journal of Molecular Liquids, 2025, 417, 126587
DOI: 10.1016/j.molliq.2024.126587

A proteome scale study reveals how plastic surfaces and agitation promote protein aggregation

Marion Schvartz, Florent Saudrais, Stéphanie Devineau, Jean-Christophe Aude, Stéphane Chédin, Céline Henry, Aarón Millán-Oropeza, Thomas Perrault, Laura Pieri, Serge Pin, Yves Boulard, Guillaume Brotons and Jean-Philippe Renault

Sci Rep, 2023, 13
DOI: 10.1038/s41598-023-28412-7

Anti-Drug Antibody Response to Therapeutic Antibodies and Potential Mitigation Strategies

Erin L. Howard, Melanie M. Goens, Leonardo Susta, Ami Patel and Sarah K. Wootton

Biomedicines, 2025, 13, 299
DOI: 10.3390/biomedicines13020299

Nanoplasmonic Avidity-Based Detection and Quantification of IgG Aggregates

Thuy Tran, Erik Martinsson, Sergio Vargas, Ingemar Lundström, Carl-Fredrik Mandenius and Daniel Aili

Anal. Chem., 2022, 94, 15754
DOI: 10.1021/acs.analchem.2c03446

Recent advances in generative biology for biotherapeutic discovery

Marissa Mock, Christopher James Langmead, Peter Grandsard, Suzanne Edavettal and Alan Russell

Trends in Pharmacological Sciences, 2024, 45, 255
DOI: 10.1016/j.tips.2024.01.003

Automated optimisation of solubility and conformational stability of antibodies and proteins

Angelo Rosace, Anja Bennett, Marc Oeller, Mie M. Mortensen, Laila Sakhnini, Nikolai Lorenzen, Christian Poulsen and Pietro Sormanni

Nat Commun, 2023, 14
DOI: 10.1038/s41467-023-37668-6

Purification and characterization of soluble recombinant Crimean-Congo hemorrhagic fever virus glycoprotein Gc expressed in mammalian 293F cells

Nigel Aminake Makoah, Matefo Millicent Litabe, Fredy Brice Nemg Simo, Katlego Keith Maboho and Felicity Jane Burt

BMC Biotechnol, 2024, 24
DOI: 10.1186/s12896-024-00885-y

Unique structure of ozoralizumab, a trivalent anti-TNFα NANOBODY® compound, offers the potential advantage of mitigating the risk of immune complex-induced inflammation

Masanao Kyuuma, Ayaka Kaku, Chiemi Mishima-Tsumagari, Bunichiro Ogawa, Mayumi Endo, Yunoshin Tamura, Kei-ichiro Ishikura, Masashi Mima, Yutaka Nakanishi and Yasuyuki Fujii

Front. Immunol., 2023, 14
DOI: 10.3389/fimmu.2023.1149874

Impact of Monoclonal Antibody Aggregates on Effector Function Characterization

Wendy J. Walton, Shousong Jason Zhang, Joseph J. Wilson, Briana N. Harvey, Matthew Clemens and Yingmei Gu

Antibodies, 2025, 14, 31
DOI: 10.3390/antib14020031

Highly variable aggregation and glycosylation profiles and their roles in immunogenicity to protein-based therapeutics

Sina Sarsarshahi, Sanghati Bhattacharya, Zeb R. Zacharias, Eman S. Kamel, Jon C.D. Houtman and Reza Nejadnik

Journal of Pharmaceutical Sciences, 2025, 114, 103771
DOI: 10.1016/j.xphs.2025.103771

Analytical control strategy for biologics. Part I: Foundations

Brent S. Kendrick, Krishnan Sampathkumar, John P. Gabrielson and Da Ren

Journal of Pharmaceutical Sciences, 2025, 114, 103826
DOI: 10.1016/j.xphs.2025.103826

Glycosylation shapes the efficacy and safety of diverse protein, gene and cell therapies

Frances Rocamora, Angelo G. Peralta, Seunghyeon Shin, James Sorrentino, Mina Ying Min Wu, Eric A. Toth, Thomas R. Fuerst and Nathan E. Lewis

Biotechnology Advances, 2023, 67, 108206
DOI: 10.1016/j.biotechadv.2023.108206

Impact of Urea on Monoclonal Antibodies: Multiple Destabilization and Aggregation Effects for Therapeutic Immunoglobulin G Proteins

Ji Young Yang, Oliver Burkert, Boris Mizaikoff and Jens Smiatek

ACS Omega, 2024, 9, 5517
DOI: 10.1021/acsomega.3c07323

Comprehensive physicochemical and functional analysis of pembrolizumab based on controlled degradation studies: Impact on antigen–antibody binding

Anabel Torrente-López, Jesús Hermosilla, Antonio Salmerón-García, José Cabeza, Adolfina Ruiz-Martínez and Natalia Navas

European Journal of Pharmaceutics and Biopharmaceutics, 2024, 194, 131
DOI: 10.1016/j.ejpb.2023.12.005

Electrochemical Protein-based Bioanalytical Devices for Drug Analysis

Caroline G. Sanz and Victor C. Diculescu

CTMC, 2023, 23, 1448
DOI: 10.2174/1568026623666230411152640

Unraveling the Effects of Filtration, Process Interruptions, and Post-Process Agitation on Protein Aggregation

Christina Winter, Anna Springer, Jean-Loup Descamps, Joris Hoefinghoff, Salehi Mohammad-Sadegh, Amrit Paudel and Milica Stankovic-Brandl

AAPS PharmSciTech, 2025, 26
DOI: 10.1208/s12249-025-03076-w

Comparative Analysis of Protein Surface Hydrophobicity Maps Determined by Sparse Sampling INDUS and Spatial Aggregation Propensity

Imee Sinha, Shekhar Garde and Steven M. Cramer

J. Phys. Chem. B, 2023, 127, 10304
DOI: 10.1021/acs.jpcb.3c04902

Self-assembled nanonization of fatty acid-conjugated vaccine antigen for enhanced thermal stability

Yeon-Ho Kim, Chulhun Park, Hy D Nguyen, Hai V Ngo and Beom-Jin Lee

International Journal of Pharmaceutics, 2024, 658, 124176
DOI: 10.1016/j.ijpharm.2024.124176

Molecular Bases of Protein Antigenicity and Determinants of Immunogenicity, Anergy, and Mitogenicity

David Pedroza-Escobar, Irais Castillo-Maldonado, Tania González-Cortés, Dealmy Delgadillo-Guzmán, Pablo Ruíz-Flores, Jorge Haro Santa Cruz, Perla-Karina Espino-Silva, Erika Flores-Loyola, Agustina Ramirez-Moreno, Joaquín Avalos-Soto, Miguel-Ángel Téllez-López, Sergio-Everardo Velázquez-Gauna, Rubén García-Garza, Rubén Daniel Arellano Pérez Vertti and Cristian Torres-León

PPL, 2023, 30, 719
DOI: 10.2174/0929866530666230907093339

Current PAT Landscape in the Downstream Processing of Biopharmaceuticals

Pavithra Sathiyapriyan, Shatanik Mukherjee, Thomas Vogel, Lars‐Oliver Essen, David Boerema, Martin Vey and Uwe Kalina

Analytical Science Advances, 2025, 6
DOI: 10.1002/ansa.70013

Machine Learning for Predicting the Drug-to-Antibody Ratio (DAR) in the Synthesis of Antibody–Drug Conjugates (ADCs)

Lorenzo Angiolini, Fabrizio Manetti, Ottavia Spiga, Andrea Tafi, Anna Visibelli and Elena Petricci

J. Chem. Inf. Model., 2025, 65, 5847
DOI: 10.1021/acs.jcim.5c00037

Advances in nanobody multimerization and multispecificity: from in vivo assembly to in vitro production

Mohammed Al-Seragi, Yilun Chen and Franck Duong van Hoa

Biochemical Society Transactions, 2025, 53, 235
DOI: 10.1042/BST20241419

Protein‐basierte Nanopartikel: Von Wirkstofftransport zu Bildgebung, Nanokatalyse und Proteintherapie

Jonas Kaltbeitzel and Peter R. Wich

Angewandte Chemie, 2023, 135
DOI: 10.1002/ange.202216097

rhGALNS Enzyme Stability in Physiological Buffers: Implications for Sustained Release

Samuel Ruesing, Samuel Stealey, Qi Gan, Linda Winter, Adriana M. Montaño and Silviya P. Zustiak

Appl Biochem Biotechnol, 2025, 197, 5148
DOI: 10.1007/s12010-025-05266-5

Exploring Protein Aggregation in Biological Products: From Mechanistic Understanding to Practical Solutions

Satish Rojekar, Amol D. Gholap, Krishna Jadhav, Ganesh Shevalkar, Vrashabh V. Sugandhi, Rohan Pai, Kinjal Parikh, Mahendra Kumar Prajapati, Nimeet Desai, Lalitkumar K. Vora, Rahul G. Ingle and Keshav Raj Paudel

AAPS PharmSciTech, 2025, 26
DOI: 10.1208/s12249-025-03189-2

A tacrolimus-eluting nerve guidance conduit enhances regeneration in a critical-sized peripheral nerve injury rat model

Azur Azapagic, Jayant Agarwal, Bruce Gale, Jill Shea, Susan Wojtalewicz and Himanshu Sant

Biomed Microdevices, 2024, 26
DOI: 10.1007/s10544-024-00717-y

US FDA-approved therapeutic antibodies with high-concentration formulation: summaries and perspectives

Shawn Shouye Wang, Yifei (Susie) Yan and Kin Ho

Antibody Therapeutics, 2021, 4, 262
DOI: 10.1093/abt/tbab027

Live Monitoring of Nanoparticle Aggregation and Sedimentation in Biological Fluids Using X-ray Photon Correlation Spectroscopy

Linfeng Wei, Chenhui Cui, Zimu Zhou, Songlin Li, Hanyu Song, Feng Tian, Xiuhong Li, Yihui Xu, Zhi Guo, Renzhong Tai and Huaidong Jiang

ACS Appl. Mater. Interfaces, 2025, 17, 45429
DOI: 10.1021/acsami.5c07078

Redirecting the JAK‐STAT signal blocks the SARS‐CoV‐2 replication

George Augustine, Valappil Sisila, Mohan Indhu, Divya Gupta, Dixit Tandel, Krishnan Harinivas Harshan, Ganesh Shanmugam, Padmanabhan Padmapriya, Srinivasan Sivasubramanian, Krishnaswamy Kaveri, Kamini Numbi Ramudu and Niraikulam Ayyadurai

Journal of Medical Virology, 2023, 95
DOI: 10.1002/jmv.28965

Unraveling the Microscopic Mechanism of Molecular Ion Interaction with Monoclonal Antibodies: Impact on Protein Aggregation

Suman Saurabh, Qinkun Zhang, John M. Seddon, Jian R. Lu, Cavan Kalonia and Fernando Bresme

Mol. Pharmaceutics, 2024, 21, 1285
DOI: 10.1021/acs.molpharmaceut.3c00963

Nano-Analytical Techniques in Pharmaceutical Analysis

C. Hima Bindu, T. Farmaan, K. Aparna, M. Sadan and T Reshma

Jordan j. pharm. sci., 2025, 18, 341
DOI: 10.35516/jjps.v18i2.2631

tANCHOR fast and cost-effective cell-based immunization approach with focus on the receptor-binding domain of SARS-CoV-2

Hubert Bernauer, Anja Schlör, Josef Maier, Norbert Bannert, Katja Hanack and Daniel Ivanusic

Biology Methods and Protocols, 2023, 8
DOI: 10.1093/biomethods/bpad030

Long-term effects of immunotherapy with a brain penetrating Aβ antibody in a mouse model of Alzheimer’s disease

Tobias Gustavsson, Nicole G. Metzendorf, Elin Wik, Sahar Roshanbin, Ulrika Julku, Aikaterini Chourlia, Per Nilsson, Ken G. Andersson, Hanna Laudon, Greta Hultqvist, Stina Syvänen and Dag Sehlin

Alz Res Therapy, 2023, 15
DOI: 10.1186/s13195-023-01236-3

Strategy to mitigate aggregation during Protein A chromatography and low pH virus inactivation for a nivolumab biosimilar candidate

Elizabeth Pargas-Ferrer, Sum Lai Lozada Chang, Katia García, Ernesto Azaharez, Julio Palacio, Midalys Cabrera Mena and Tammy Boggiano-Ayo

Journal of Chromatography A, 2025, 1743, 465698
DOI: 10.1016/j.chroma.2025.465698

Investigating Local Sequence‐Structural Attributes of Amyloidogenic Light Chain Variable Domains

Puneet Rawat, R. Prabakaran, Divya Sharma, Vasanth Mandala, Victor Greiff, Sandeep Kumar and M. Michael Gromiha

Proteins, 2025, 93, 1451
DOI: 10.1002/prot.26815

Relationships between surface tensiometry properties and fluorescence intensity of dark and light exposed monoclonal antibody Nivolumab/Opdivo® by using the contact angle method: A pilot study

Giorgia Miolo, Elisabetta De Diana, Patrizia Polverino de Laureto, Nicola Realdon, Sergio Rossi and Davide Rossi

Journal of Pharmaceutical Sciences, 2025, 114, 103823
DOI: 10.1016/j.xphs.2025.103823

Transformative protein scaffold designs for dual-modality cancer applications: Advances in therapeutic delivery and molecular imaging of tumor microenvironments

Mohammed Alissa, Abdullah Alghamdi, Suad A. Alghamdi, Mohammed A. Alshehri, Ghfren S. Aloraini, Abdullah Albelasi and Mohammed S. Alshammari

International Journal of Biological Macromolecules, 2025, 318, 144881
DOI: 10.1016/j.ijbiomac.2025.144881

From precision synthesis to cross-industry applications: The future of emerging peptide technologies

Mingming Wang, Hongmin Xia, Cheng Wang, Tong Zhang, Mengru Zhang, Xinyi Li, Chune Peng, Tianyuan Jing, Yuwei Wang, Lizeng Peng and Ping Wang

Pharmacological Research, 2025, 218, 107839
DOI: 10.1016/j.phrs.2025.107839

Zwitterionic Polymer: A New Paradigm for Protein Conjugation beyond PEG

Zhipeng Zeng, Shi Chen and Yongming Chen

ChemMedChem, 2023, 18
DOI: 10.1002/cmdc.202300245

Synthetic T-Cell Receptor-like Protein Behaves as a Janus Particle in Solution

Emily Sakamoto-Rablah, Jordan Bye, Arghya Modak, Andrew Hooker, Shahid Uddin and Jennifer J. McManus

J. Am. Chem. Soc., 2025, 147, 247
DOI: 10.1021/jacs.4c08932

AggNet: Advancing protein aggregation analysis through deep learning and protein language model

Wenjia He, Xiaopeng Xu, Haoyang Li, Juexiao Zhou and Xin Gao

Protein Science, 2025, 34
DOI: 10.1002/pro.70031

Molecular Docking, Dynamics, and WaterSwap Analysis to Identify Anti-aggregating Agents of Insulin and IFN-β

Priyanka Sharma, Baddipadige Raju, Gera Narendra, Bharti Sapra and Om Silakari

Appl Biochem Biotechnol, 2022, 194, 3261
DOI: 10.1007/s12010-022-03881-0

Impact of stirring material on formation of submicron and subvisible aggregates in mAbs by quantitative laser diffraction, dynamic light scattering and background membrane imaging

Utkarsh Tathe, Sampada Khopkar, Pratap Rasam, Aswani Kancherla, Prajakta Dandekar and Ratnesh Jain

International Journal of Pharmaceutics, 2024, 660, 124321
DOI: 10.1016/j.ijpharm.2024.124321

Anti-angiogenic biomolecules in neovascular age-related macular degeneration; therapeutics and drug delivery systems

Mir Salar Kazemi, Alireza Shoari, Neda Salehibakhsh, Hooman Aghamirza Moghim Aliabadi, Mohammad Abolhosseini, Seyed Shahriar Arab, Hamid Ahmadieh, Mozhgan Rezaei Kanavi and Mahdi Behdani

International Journal of Pharmaceutics, 2024, 659, 124258
DOI: 10.1016/j.ijpharm.2024.124258

Improving product quality and productivity of an antibody-based biotherapeutic using inverted frustoconical shaking bioreactors

Xuekun Wang, Jin Xu, Qingcheng Guo, Zhenhua Li, Jiawei Cao, Rongrong Fu, Mengjiao Xu, Xiang Zhao, Fugui Wang, Xinmeng Zhang, Taimin Dong, Xu Li, Weizhu Qian, Shen Hou, Lusha Ji, Dapeng Zhang and Huaizu Guo

Front. Bioeng. Biotechnol., 2024, 12
DOI: 10.3389/fbioe.2024.1352098

Facile Synthesis of Peptide-Conjugated Gold Nanoclusters with Different Lengths

Qun Ma, Lichao Liu, Zeyue Yang and Peng Zheng

Nanomaterials, 2021, 11, 2932
DOI: 10.3390/nano11112932

High-Throughput Counting and Sizing of Therapeutic Protein Aggregates in the Nanometer Size Range by Nano-Flow Cytometry

Kaimin Gao, Hong Lian, Chengfeng Xue, Jing Zhou and Xiaomei Yan

Anal. Chem., 2022, 94, 17634
DOI: 10.1021/acs.analchem.2c04382

Fibrillation of Human Serum Albumin Differentially Affected by Asp-, Arg-, and Tyr-Capped Gold Nanoparticles

Sreshtha Chaki, Sujan Santra and Swagata Dasgupta

J. Phys. Chem. B, 2024, 128, 3538
DOI: 10.1021/acs.jpcb.3c06932

Enhancing monoclonal antibody stability during protein a chromatography using 2-methyl imidazolium dihydrogen phosphate

Ranjeet Desai, Rahul Jaiswal, Triveni Manchekar, Shailesh Dugam, Ratnesh Jain and Prajakta Dandekar

Journal of Chromatography A, 2024, 1733, 465263
DOI: 10.1016/j.chroma.2024.465263

Exploring the thermodynamics of protein aggregation: an insight to Huntington's disease therapeutics

Rajinder Singh Kaundal, Tejasvi Pandey and Vivek Pandey

Neurosci Behav Physi, 2024, 54, 1042
DOI: 10.1007/s11055-024-01639-1

Protein-based nano delivery systems focusing on protein materials, fabrication strategies and applications in ischemic stroke intervention: A review

Chao Yan, XuChun Zhu, Yingying Ren, Shanyue Guan, Shan He, Feng Qiu, Mingzheng Huang, Xiaozhong Qu and Hongzhi Liu

International Journal of Biological Macromolecules, 2025, 311, 143645
DOI: 10.1016/j.ijbiomac.2025.143645

Instability Challenges and Stabilization Strategies of Pharmaceutical Proteins

Mohsen Akbarian and Shu-Hui Chen

Pharmaceutics, 2022, 14, 2533
DOI: 10.3390/pharmaceutics14112533

Hinge Truncation to Improve Aggregation Kinetics and Thermal Stability of an Antibody Fab Fragment

Cheng Zhang, Kersti Karu and Paul A. Dalby

Mol. Pharmaceutics, 2025, 22, 5389
DOI: 10.1021/acs.molpharmaceut.5c00358

In vitro and in vivo studies of plant-produced Atezolizumab as a potential immunotherapeutic antibody

Kaewta Rattanapisit, Christine Joy I. Bulaon, Richard Strasser, Hongyan Sun and Waranyoo Phoolcharoen

Sci Rep, 2023, 13
DOI: 10.1038/s41598-023-41510-w

The handling of biopharmaceuticals used in home-based therapy for cancer patients

Lisa Hardebol, Charlotte Sikking, Marlou Florack and Mirjam Crul

International Journal of Pharmacy Practice, 2023, 31, 298
DOI: 10.1093/ijpp/riad008

Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies

Chantal T. Harris and Sivan Cohen

BioDrugs, 2024, 38, 205
DOI: 10.1007/s40259-023-00641-2

Pre-Clinical In-Vitro Studies on Parameters Governing Immune Complex Formation

Marie Fichter, Gesa Richter, Alexander Bepperling and Paul Wassmann

Pharmaceutics, 2022, 14, 1254
DOI: 10.3390/pharmaceutics14061254

QTY code designed antibodies for aggregation prevention: A structural bioinformatic and computational study

Mengke Li, Yanze Wang, Fei Tao, Ping Xu and Shuguang Zhang

Proteins, 2024, 92, 206
DOI: 10.1002/prot.26603

Oligomerization and Adjuvant Activity of Peptides Derived from the VirB4-like ATPase of Clostridioides difficile

Julya Sorokina, Irina Sokolova, Mariya Majorina, Anastasia Ungur, Vasiliy Troitskiy, Amir Tukhvatulin, Bogdan Melnik and Yury Belyi

Biomolecules, 2023, 13, 1012
DOI: 10.3390/biom13061012

Design Principles for Immunomodulatory Biomaterials

Samuel Abidemi Oluwole, Welday Desta Weldu, Keerthana Jayaraman, Kelsie Amanda Barnard and Christian Agatemor

ACS Appl. Bio Mater., 2024, 7, 8059
DOI: 10.1021/acsabm.4c00537

Exploring the next generation of antibody–drug conjugates

Kyoji Tsuchikama, Yasuaki Anami, Summer Y. Y. Ha and Chisato M. Yamazaki

Nat Rev Clin Oncol, 2024, 21, 203
DOI: 10.1038/s41571-023-00850-2

Unraveling the physiochemical characteristics and molecular insights of Zein protein through structural modeling and conformational dynamics: a synergistic approach between machine learning and molecular dynamics simulations

Amit Kumar Srivastav, Jyoti Jaiswal and Umesh Kumar

Journal of Biomolecular Structure and Dynamics, 2024, 1
DOI: 10.1080/07391102.2024.2428825

Experimental procedures to investigate fibrillation of proteins

Chinmaya Panda, Laipubam Gayatri Sharma and Lalit M. Pandey

MethodsX, 2023, 11, 102445
DOI: 10.1016/j.mex.2023.102445

Antigen Delivery Platforms for Next-Generation Coronavirus Vaccines

Aziz A. Chentoufi, Jeffrey B. Ulmer and Lbachir BenMohamed

Vaccines, 2024, 13, 30
DOI: 10.3390/vaccines13010030

On the humanization of VHHs: Prospective case studies, experimental and computational characterization of structural determinants for functionality

Monica L. Fernández‐Quintero, Enrico Guarnera, Djordje Musil, Lukas Pekar, Carolin Sellmann, Filipe Freire, Raquel L. Sousa, Sandra P. Santos, Micael C. Freitas, Tiago M. Bandeiras, Margarida M. S. Silva, Johannes R. Loeffler, Andrew B. Ward, Julia Harwardt, Stefan Zielonka and Andreas Evers

Protein Science, 2024, 33
DOI: 10.1002/pro.5176

Liquid-liquid phase separation driven by charge heterogeneity

Daniele Notarmuzi and Emanuela Bianchi

Commun Phys, 2024, 7
DOI: 10.1038/s42005-024-01875-4

Streamlining biosimilar development based on 20 years’ experience

Cecil Nick

Expert Opinion on Biological Therapy, 2024, 24, 571
DOI: 10.1080/14712598.2024.2314612

Artificial intelligence in drug development for delirium and Alzheimer’s disease

Ruixue Ai, Xianglu Xiao, Shenglong Deng, Nan Yang, Xiaodan Xing, Leiv Otto Watne, Geir Selbæk, Yehani Wedatilake, Chenglong Xie, David C. Rubinsztein, Jennifer E. Palmer, Bjørn Erik Neerland, Hongming Chen, Zhangming Niu, Guang Yang and Evandro Fei Fang

Acta Pharmaceutica Sinica B, 2025
DOI: 10.1016/j.apsb.2025.04.026

Characterization of free light chain impurity in a bispecific antibody

Monica Sadek, Neelima Mantha, Steffen Lippold, Delia Li, Kyle Spitler, Ran Li, Phillip Spinosa, Bob Liu, Steven Luu, Nicholas Woon, Yeying Zhang, Jia Guo, Renee Yang, Jonathan Zarzar and Yi Yang

mAbs, 2025, 17
DOI: 10.1080/19420862.2025.2527689

Target-independent Immune-cell Activation by Aggregates of T Cell-redirecting Bispecific Antibodies

Minoru Tada, Michihiko Aoyama and Akiko Ishii-Watabe

Journal of Pharmaceutical Sciences, 2023, 112, 2419
DOI: 10.1016/j.xphs.2023.06.016

Understanding and controlling the molecular mechanisms of protein aggregation in mAb therapeutics

Kuin Tian Pang, Yuan Sheng Yang, Wei Zhang, Ying Swan Ho, Pietro Sormanni, Thomas C.T. Michaels, Ian Walsh and Sean Chia

Biotechnology Advances, 2023, 67, 108192
DOI: 10.1016/j.biotechadv.2023.108192

Immunogenicity risk assessment and mitigation for engineered antibody and protein therapeutics

Paul J. Carter and Valerie Quarmby

Nat Rev Drug Discov, 2024, 23, 898
DOI: 10.1038/s41573-024-01051-x

Discovery and Characterization of an Acid-Labile Serine-Lysine Cross-Link in Antibody High-Molecular-Weight Species Using a Multipronged Mass Spectrometry Approach

Gao-Yuan Liu, Zhengqi Zhang, Yuetian Yan, Shunhai Wang and Ning Li

Anal. Chem., 2023, 95, 13813
DOI: 10.1021/acs.analchem.3c01602

Characterization and root cause analysis of immunogenicity to pasotuxizumab (AMG 212), a prostate-specific membrane antigen-targeting bispecific T-cell engager therapy

Hweixian Leong Penny, Kelly Hainline, Nathaniel Theoharis, Bin Wu, Christian Brandl, Christian Webhofer, Mason McComb, Sabine Wittemer-Rump, Gökben Koca, Sabine Stienen, Ralf C. Bargou, Horst-Dieter Hummel, Wolfgang Loidl, Carsten Grüllich, Tobias Eggert, Ben Tran and Daniel T. Mytych

Front. Immunol., 2023, 14
DOI: 10.3389/fimmu.2023.1261070

Pre-Concentration Freezing Alters the Composition of Mesenchymal Stem/Stromal Cell-Conditioned Medium

Francesca Cadelano, Chiara Giannasi, Alice Gualerzi, Martina Gerli, Stefania Niada, Elena Della Morte and Anna Teresa Brini

Biology, 2025, 14, 181
DOI: 10.3390/biology14020181

Evaluation of the potential immunogenicity of recombinant human bone morphogenetic proteins

U. F. Mukhametov, S. V. Lyulin, D. Yu. Borzunov and I. F. Gareev

jour, 2022, 21, 116
DOI: 10.52420/2071-5943-2022-21-5-116-127

Complexing Protein-Free Botulinum Neurotoxin A Formulations: Implications of Excipients for Immunogenicity

Michael Uwe Martin, Juergen Frevert and Clifton Ming Tay

Toxins, 2024, 16, 101
DOI: 10.3390/toxins16020101

Topical delivery of anti-VEGF macromolecules for retinopathy: A review

Varaprasad R. Regu, Ranjit P. Swain, Lolly Pattnaik and Bharat B. Subudhi

International Journal of Biological Macromolecules, 2025, 312, 144151
DOI: 10.1016/j.ijbiomac.2025.144151

In-line fiber optical sensor for detection of IgG aggregates in affinity chromatography

Thuy Tran, Robert Gustavsson, Erik Martinsson, Filip Bergqvist, Andreas Axen, Ingemar Lundström, Carl-Fredrik Mandenius and Daniel Aili

Journal of Chromatography A, 2024, 1730, 465129
DOI: 10.1016/j.chroma.2024.465129

Aggregation of therapeutic monoclonal antibodies due to thermal and air/liquid interfacial agitation stress: Occurrence, stability assessment strategies, aggregation mechanism, influencing factors, and ways to enhance stability

Shravan Sreenivasan, Christian Schöneich and Anurag S. Rathore

International Journal of Pharmaceutics, 2024, 666, 124735
DOI: 10.1016/j.ijpharm.2024.124735

Probing the Biosafety of Implantable Artificial Secretory Granules for the Sustained Release of Bioactive Proteins

Patricia Álamo, Eloi Parladé, Marianna T. P. Favaro, Alberto Gallardo, Rosa Mendoza, Luís C. S. Ferreira, Nerea Roher, Ramón Mangues, Antonio Villaverde and Esther Vázquez

ACS Appl. Mater. Interfaces, 2023, 15, 39167
DOI: 10.1021/acsami.3c08643