In this study, we investigated the concentration range in which self-association starts to form in humanized IgG monoclonal antibody (mAb) solutions. Furthermore, on the basis of the results, we developed a practical method of screening for low-viscosity antibody solutions by using small-angle X-ray scattering (SAXS) measurements utilizing small quantities of samples. With lower-viscosity mAb3, self-association was not detected in the range of 1-80mg/mL. With higher-viscosity mAb1, on the other hand, self-association was detected in the range of 10-20mg/mL and was clearly enhanced by a decrease in temperature. The viscosities of mAb solutions at 160, 180, and 200mg/mL at 25°C quantitatively correlated very well with the particle size parameters obtained by SAXS measurements of mAb solutions at 15mg/mL at 5°C. The quantity of mAb sample required for the SAXS measurements was only 0.15mg, which is about one-hundredth of that required for actual viscosity measurements at a high concentration, and such quantities could be available even at an early stage of development. In conclusion, the SAXS analysis method proposed in this study is a valuable tool for the development of concentrated mAb therapeutics with high manufacturability and high usability for subcutaneous injection.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.ejpb.2016.11.027 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Enhancing lane detection in autonomous vehicles with multi-armed bandit ensemble learning.
Sci Rep
January 2025
School of Computer Science Engineering and Information Systems, Vellore Institute of Technology, Vellore, India.
This study introduces a novel ensemble learning technique namely Multi-Armed Bandit Ensemble (MAB-Ensemble), designed for lane detection in road images intended for autonomous vehicles. The foundation of the proposed MAB-Ensemble technique is inspired in terms of Multi-Armed bandit optimization to facilitate efficient model selection for lane segmentation. The benchmarking dataset namely TuSimple is used for training, validating and testing the proposed and existing lane detection techniques.
View Article and Find Full Text PDFCharacteristics and treatment patterns in patients with multiple myeloma in Japan: A retrospective cohort analysis.
PLoS One
January 2025
GSK, Stevenage, Hertfordshire, United Kingdom.
Background: Approval of proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies (mAbs), such as daratumumab, has reshaped treatment patterns in patients with multiple myeloma (MM) in Japan. This retrospective study evaluated patient characteristics, treatment patterns, and trends in MM patients using Medical Data Vision, the largest electronic health records database in Japan with anonymous inpatient and outpatient health information.
Methods: Patients aged ≥18 years, with ≥2 records of an MM diagnostic and disease code and ≥1 record of MM treatment between 01 April 2008 and 30 June 2023 were included.
Rapid Development of High Concentration Protein Formulation Driven by High-Throughput Technologies.
Pharm Res
January 2025
BioDev Department WuXi Biologics USA, 1 Cedarbrook Dr, Cranbury, NJ, 08512, USA.
Background: High concentration protein formulation (HCPF) development needs to balance protein stability attributes such as conformational/colloidal stability, chemical stability, and solution properties such as viscosity and osmolality.
Methodology: A three-phase design is established in this work. In Phase 1, conformational and colloidal stability are measured by 384-well-based high-throughput (HT) biophysical screening while viscosity reduction screening is performed with HT viscosity screening.
Structure and Dynamics of Monoclonal Antibody Domains Using Spins, Scattering, and Simulations.
ChemMedChem
January 2025
Institute for Bioscience and Biotechnology Research, University of Maryland, 9600 Gudelsky Drive, Rockville, Maryland, 20850, United States.
Antibody-based pharmaceuticals are the leading biologic drug platform (> $75B/year). Despite a wealth of information collected on them, there is still a lack of knowledge on their inter-domain structural distributions, which impedes innovation and development. To address this measurement gap, we have developed a new methodology to derive biomolecular structure ensembles from distance distribution measurements via a library of tagged proteins bound to an unlabeled and otherwise unmodified target biologic.
View Article and Find Full Text PDFAutogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial.
Nat Med
January 2025
Department of Medicine-Medical Oncology, University of Colorado Cancer Center, Denver, CO, USA.
Effective targeting of somatic cancer mutations to enhance the efficacy of cancer immunotherapy requires an individualized approach. Autogene cevumeran is a uridine messenger RNA lipoplex-based individualized neoantigen-specific immunotherapy designed from tumor-specific somatic mutation data obtained from tumor tissue of each individual patient to stimulate T cell responses against up to 20 neoantigens. This ongoing phase 1 study evaluated autogene cevumeran as monotherapy (n = 30) and in combination with atezolizumab (n = 183) in pretreated patients with advanced solid tumors.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!