High-concentration biologic formulations: challenges, strategies, and emerging technologies for subcutaneous delivery

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Ma J. European Journal of Pharmaceutics and Biopharmaceutics. 2026 July. Volume 226. Article 115178. doi: 10.1016/j.ejpb.2026.115178 .

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High-concentration biologic formulations: challenges, strategies, and emerging technologies for subcutaneous delivery
Safety, Tolerability, and Pharmacokinetics of HBM9378 (SKB378/WIN378), a Fully Human IgG1 Monoclonal Antibody Against TSLP After Single Ascending Doses in Chinese Healthy Subjects
Modeling and addressing on-target/off-tumor toxicity of claudin 18.2 targeted immunotherapies
An affinity-modulated T cell engager targeting Claudin 18.2 shows potent anti-tumor activity with limited cytokine release
Immunotherapy for rapid bone marrow conditioning and leukemia depletion that allows efficient hematopoietic stem cell transplantation
Efficacy and safety of HBM4003 combined with toripalimab in refractory neuroendocrine neoplasms: a multicenter, phase II study
PF-08052666 (SGN-MesoC2; HBM9033), a first-in-class topoisomerase 1 inhibitor-based ADC targeting MSLN, demonstrates potent antitumor activity in preclinical models of ovarian, lung, and colorectal cancers
Porustobart (HBM4003) plus toripalimab as second-line therapy in patients with advanced hepatocellular carcinoma: a multicenter, open-label, phase I study
Toripalimab in combination with HBM4003, an anti-CTLA-4 heavy chain-only antibody, in advanced melanoma and other solid tumors: an open-label phase I trial
Batoclimab vs placebo for generalized myasthenia gravis: a randomized clinical trial
Generation and preclinical evaluation of a human heavy-chain-only antibody recognizing the membrane-bound tumor-associated antigen mesothelin
Filamentous fungus-produced human monoclonal antibody provides protection against SARS-CoV-2 in hamster and non-human primate models
High throughput identification of human monoclonal antibodies and heavy-chain-only antibodies to treat snakebite
Avidity engineering of human heavy-chain-only antibodies mitigates neutralization resistance of SARS-CoV-2 variants
HBM1022: an afucosylated anti-CCR8 antibody, depletes specifically tumor infiltrating Tregs and inhibits tumor growth with excellent safety profile in preclinical studies
Nanoparticles targeting hematopoietic stem and progenitor cells: Multimodal carriers for the treatment of hematological diseases
Antigenic structure of the human coronavirus OC43 spike reveals exposed and occluded neutralizing epitopes
TNF-α inhibitor tanfanercept (HBM9036) improves signs and symptoms of dry eye in a phase 2 trial in the controlled adverse environment in China
A transgenic heavy chain IgG mouse platform as a source of high affinity fully human single-domain antibodies for therapeutic applications
WNT/beta-catenin signalling interrupts a senescence-induction cascade in human mesenchymal stem cells that restricts their expansion
An anti-CTLA-4 heavy chain-only antibody with enhanced Treg depletion shows excellent preclinical efficacy and safety profile
A phase I study of HBM4003, an anti-CTLA-4 heavy chain only monoclonal antibody, in combination with toripalimab in advanced melanoma
Innovative B7H4 x CD3 & B7H4 x 4-1BB bispecifics for solid tumor therapies
SARS-CoV-2 neutralizing human antibodies protect against lower respiratory tract disease in a hamster model
Therapeutic response and possible biomarkers in acute attacks of neuromyelitis optica spectrum disorders: a prospective observational study
Safety, tolerability, pharmacokinetics, and pharmacodynamics of HBM9161, a novel FcRn inhibitor, in a phase I study for healthy Chinese volunteers
A conserved immunogenic and vulnerable site on the coronavirus spike protein delineated by cross-reactive monoclonal antibodies
Structural basis for SARS-CoV-2 neutralizing antibodies with novel binding epitopes
Discover potent and functional human antibodies against a new B7-family member target for cancer immunotherapy
Cell Engager Summit Exclusive Speaker Interview
Preclinical evaluation of HBM7022, an HBICE™ 2+1 CLDN18.2 x CD3 bispecific antibody, for gastric cancer
Development of fully human T-cell engaging bispecific antibodies targeting B7H4
A human monoclonal antibody blocking SARS-CoV-2 infection
Multimeric single-domain antibody complexes protect against bunyavirus infections
HCAb based bispecific immune cell engager (HBICE) platform enables fast and convenient generation of the next generation bispecific antibodies with high potency, promising safety profiles and excellent developability
HBM1022, a novel anti-CCR8 antibody, depletes tumor-infiltrating regulatory T cells via enhanced ADCC activity, mediates potent anti-tumor activity
Novel monoclonal antibodies (mAbs) targeting human CCR8 provide potential candidates for next generation cancer immunotherapy
Discovery of potent and functional human antibodies against a new B7-family member, B7H7, for cancer immunotherapy
HBM1007 – A highly potent anti-CD73 mAb candidate for mono and combination IO therapy
BCMA x CD3 bispecific antibody – a novel HBICE™-based molecule with efficient tumor killing and minimal cytokine release
Towards a solution to MERS: protective human monoclonal antibodies targeting different domains and functions of the MERS-coronavirus spike glycoprotein
A heavy chain only antibody against CTLA4 with outstanding preclinical efficacy and safety profile
A new generation of fully human anti-CTLA-4 heavy chain only antibody
A biparatopic agonistic antibody that mimics fibroblast growth factor 21 ligand activity
Expression cloning and production of human heavy-chain-only antibodies from murine transgenic plasma cells
Heavy chain-only antibodies and tetravalent bispecific antibody neutralizing Staphylococcus aureus leukotoxins
Generation of heavy-chain-only antibodies in mice
Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double- Blinded, Randomized, Placebo-Controlled Phase II Study

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