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1. Monoclonal antibody purification and its progression to commercial scale

Author:
Chahar, Digamber Singh; Ravindran, Selvan; Pisal, S.S.
Source:
Biologicals 2020 v.63 pp. 1-13
ISSN:
1045-1056
Subject:
monoclonal antibodies,   etc   ; filtration; manufacturing; markets;     Show all 4 Subjects
Abstract:
... With the advancements in upstream technologies, the capacity for monoclonal antibody (mAb) production has transformed from a few milligrams to grams per liter. These titers lead to enormous pressure on downstream processes (DSPs), which need to be reworked to achieve higher efficiency and better utilization of available resources. Various parameters, such as column sizing, aggregate removal, filtr ...
DOI:
10.1016/j.biologicals.2019.09.007

2. Optimization study on periodic counter-current chromatography integrated in a monoclonal antibody downstream process

Author:
Gomis-Fons, Joaquín; Andersson, Niklas; Nilsson, Bernt
Source:
Journal of chromatography 2020 v.1621 pp. 461055
ISSN:
0021-9673
Subject:
monoclonal antibodies,   etc   ; countercurrent chromatography; mechanistic models;     Show all 3 Subjects
Abstract:
... An optimization study of an integrated periodic counter-current chromatography (PCC) process in a monoclonal antibody (mAb) downstream process at lab scale, is presented in this paper. The optimization was based on a mechanistic model of the breakthrough curve in the protein-A capture step. Productivity and resin utilization were the objective functions, while yield during the loading of the captu ...
DOI:
10.1016/j.chroma.2020.461055

3. A palladium-catalyst stabilized in the chiral environment of a monoclonal antibody in water

Author:
Kobayashi, Yuichiro; Murata, Keisuke; Harada, Akira; Yamaguchi, Hiroyasu
Source:
Chemical communications 2020 v.56 no.10 pp. 1605-1607
ISSN:
1364-548X
Subject:
monoclonal antibodies,   etc   ; amination; catalysts; catalytic activity; palladium;     Show all 5 Subjects
Abstract:
... We report the first preparation of a monoclonal antibody (mAb) that can immobilize a palladium (Pd)-complex. The allylic amination reaction using a supramolecular catalyst consisting of the Pd-complex and mAb selectively gives the (R)-enantiomer product with an enantiomeric excess (ee) of 98 ± 2%. This is in sharp contrast to the reaction catalyzed by a conventional Pd-catalyst (ee < 2%). ...
DOI:
10.1039/c9cc08756g

4. CD11d is a novel antigen on chicken leukocytes

Author:
Deeg, Cornelia A.; Degroote, Roxane L.; Giese, Isabella M.; Hirmer, Sieglinde; Amann, Barbara; Weigand, Maria; Wiedemann, Carmen; Hauck, Stefanie M.
Source:
Journal of proteomics 2020 v.225 pp. 103876
ISSN:
1874-3919
Subject:
monoclonal antibodies,   etc   ; antigens; chickens; integrins; leukocytes; mice; protein content;     Show all 7 Subjects
Abstract:
... In life sciences, antibodies are among the most commonly used tools for identifying, tracking, quantifying and isolating molecules, mainly proteins. However, it has recently become clear that antibodies often fall short with respect to specificity and selectivity and in many cases target proteins are not even known. When commercial availability of antibodies is scarce, e.g. for targeting proteins ...
DOI:
10.1016/j.jprot.2020.103876

5. Viral clearance capacity by continuous Protein A chromatography step using Sequential MultiColumn Chromatography

Author:
Goussen, Caroline; Goldstein, Laëtitia; Brèque, Corinne; You, Bruno; Boyer, Stéphane; Bataille, Damien; Burlot, Ludovic
Source:
Journal of chromatography 2020 v.1145 pp. 122056
ISSN:
1570-0232
Subject:
monoclonal antibodies,   etc   ; biopharmaceuticals; chromatography; manufacturing; proteins; risk reduction; therapeutics; viruses;     Show all 8 Subjects
Abstract:
... In response to the strong demand of biological protein therapeutics, such as monoclonal antibodies (MAbs), continuous downstream process was developed to deliver these molecules while maintaining desired product consistency and quality attributes, and providing manufacturing efficiency and flexibility. Viral safety is a critical quality attribute for biopharmaceuticals, such as MAbs. Evaluation of ...
DOI:
10.1016/j.jchromb.2020.122056

6. Accelerating the development of novel technologies and tools for the subcutaneous delivery of biotherapeutics

Author:
Collins, David S.; Sánchez-Félix, Manuel; Badkar, Advait V.; Mrsny, Randall
Source:
Journal of controlled release 2020 v.321 pp. 475-482
ISSN:
0168-3659
Subject:
monoclonal antibodies,   etc   ; biopharmaceuticals; commercialization; drug development; experts; industry; intravenous injection;     Show all 7 Subjects
Abstract:
... Subcutaneous (SC) delivery of biotherapeutics is well established as a route of administration across many therapeutic areas and has been shown to be effective and well-tolerated. It can offer several advantages over intravenous administration. This notwithstanding, there remain critical development issues and knowledge gaps in SC drug delivery. To articulate and address these issues, the SC Drug ...
DOI:
10.1016/j.jconrel.2020.02.036

7. Induction of ADCC by a folic acid–mAb conjugate prepared by tryptophan-selective reaction toward folate-receptor-positive cancer cells

Author:
Tagawa, Hiroshi; Maruyama, Katsuya; Sasaki, Koichi; Konoue, Natsuki; Kishimura, Akihiro; Kanai, Motomu; Mori, Takeshi; Oisaki, Kounosuke; Katayama, Yoshiki
Source:
RSC advances 2020 v.10 no.28 pp. 16727-16731
ISSN:
2046-2069
Subject:
monoclonal antibodies,   etc   ; cytotoxicity; folic acid; neoplasm cells; neoplasms; tryptophan;     Show all 6 Subjects
Abstract:
... We developed conjugates between monoclonal antibody (mAb) and folic acid (FA) by using a tryptophan (Trp)-selective reaction, which yields relatively homogenous products compared to conventional methods. The obtained mAb–FA conjugates showed significant cellular cytotoxicity toward folate receptor-expressing cancer cells, demonstrating that the conjugates retained the Fc region's original function ...
DOI:
10.1039/d0ra03291c

8. One-pot synthesis of heterodimeric agonists that activate the canonical Wnt signaling pathway

Author:
Mukherjee, Abhirup; Stathos, Mark E.; Varner, Chad; Arsiwala, Ammar; Frey, Steven; Hu, Yuge; Smalley, David M.; Schaffer, David V.; Kane, Ravi S.
Source:
Chemical communications 2020 v.56 no.25 pp. 3685-3688
ISSN:
1364-548X
Subject:
monoclonal antibodies,   etc   ; agonists; chemical reactions; ligands; mammals; signal transduction; synthesis;     Show all 7 Subjects
Abstract:
... Fragment antigen-binding domains (Fabs) from anti-Frizzled and anti-LRP6 monoclonal antibodies were conjugated using SpyTag–SpyCatcher chemistry via a one-pot reaction. The resulting synthetic heterodimeric agonist outperformed the natural ligand, Wnt-3a, in activating canonical Wnt signaling in mammalian cells. This approach should be broadly applicable to activate receptor-mediated cellular sign ...
DOI:
10.1039/d0cc00920b
PubMed:
32119023
PubMed Central:
PMC7179975

9. Boosting Cytotoxic Antibodies against Cancer

Author:
Gauthier, Laurent; Vivier, Eric
Source:
Cell 2020 v.180 no.5 pp. 822-824
ISSN:
0092-8674
Subject:
monoclonal antibodies,   etc   ; antigens; cytotoxicity; drugs; neoplasm cells; neoplasms;     Show all 6 Subjects
Abstract:
... Monoclonal antibodies (mAbs) targeting antigens expressed at the surface of tumor cells are widely used for cancer control in clinics, but these treatments need to be improved. Chew et al. show how an old drug, prochlorperazine, could be repurposed to enhance the efficacy of anti-tumor mAbs by increasing the cell-surface expression of tumor antigens. ...
DOI:
10.1016/j.cell.2020.02.025

10. A frontal analysis combined with a simultaneous chromatographic analysis of macromolecules using a single chromatographic system

Author:
Ambrožič, Rok; Modic, Petra; Hribar, Gorazd; Podgornik, Aleš
Source:
Journal of chromatography 2020 v.1610 pp. 460571
ISSN:
0021-9673
Subject:
monoclonal antibodies,   etc   ; absorbance; algorithms; cations; chromatography; detection limit; monitoring; plasmids;     Show all 8 Subjects
Abstract:
... A chromatographic system was adapted to allow monitoring of eluent of preparative column via absorbance and with the chromatographic analysis of the target macromolecule on the same chromatographic system. The proposed approach was tested on important macromolecules, such as monoclonal antibodies, monoclonal antibody aggregates and plasmid DNA (pDNA). A frontal analysis was made on the preparative ...
DOI:
10.1016/j.chroma.2019.460571

11. Nanoparticle Conjugation Stabilizes and Multimerizes β-Hairpin Peptides To Effectively Target PD-1/PD-L1 β-Sheet-Rich Interfaces

Author:
Jeong, Woo-jin; Bu, Jiyoon; Han, Yanxiao; Drelich, Adam J.; Nair, Ashita; Král, Petr; Hong, Seungpyo
Source:
Journal of the American Chemical Society 2020 v.142 no.4 pp. 1832-1837
ISSN:
1520-5126
Subject:
monoclonal antibodies,   etc   ; antagonists; geometry; immunotherapy; ligands; nanoparticles; neoplasms; peptides;     Show all 8 Subjects
Abstract:
... β-Hairpin peptides present great potential as antagonists against β-sheet-rich protein surfaces, of which wide and flat geometries are typically “undruggable” with small molecules. Herein, we introduce a peptide–dendrimer conjugate (PDC) approach that stabilizes the β-hairpin structure of the peptide via intermolecular forces and the excluded volume effect as well as exploits the multivalent bindi ...
DOI:
10.1021/jacs.9b10160

12. Development of anti-drug monoclonal antibody panels against adalimumab and infliximab

Author:
Suzuki, Takuo; Tada, Minoru; Ishii-Watabe, Akiko
Source:
Biologicals 2020 v.63 pp. 39-47
ISSN:
1045-1056
Subject:
monoclonal antibodies,   etc   ; humans; models; neutralization; neutralizing antibodies; patients; pharmacokinetics; therapeutics;     Show all 8 Subjects
Abstract:
... The generation of anti-drug antibodies (ADAs) is one of the most serious problems in therapy using monoclonal antibodies (mAbs), because ADAs can impact the pharmacokinetics, efficacy, and safety of mAbs. It is therefore important to detect the generated ADAs in patients. For the appropriate detection of ADAs, methods that detect various types of ADAs (e.g., low- and high-affinity ADAs) are needed ...
DOI:
10.1016/j.biologicals.2019.12.003

13. Quality by Design approaches to assessing the robustness of tangential flow filtration for MAb

Author:
Wee, Hyun; Koo, KeunHoe; Bae, EunJeong; Lee, TaekYeol
Source:
Biologicals 2020 v.63 pp. 53-61
ISSN:
1045-1056
Subject:
monoclonal antibodies,   etc   ; case studies; filtration; models; quality control; risk assessment;     Show all 6 Subjects
Abstract:
... Quality by Design (QbD) is a modern approach for quality assurance in pharmaceutical production. This article illustrates a case study of TFF robustness performed for a process characterization of a monoclonal antibody under QbD principles by exploring functional relationships that link the process parameters to quality/process attributes with prior process knowledge, risk assessment, and multivar ...
DOI:
10.1016/j.biologicals.2019.12.001

14. Dromedary camel CD14high MHCIIhigh monocytes display inflammatory properties and are reduced in newborn camel calves

Author:
Hussen, Jamal; Shawaf, Turke; Al-Mubarak, Abdullah I. A.; Al Humam, Naser Abdallah; Almathen, Faisal; Schuberth, Hans-Joachim
Source:
BMC veterinary research 2020 v.16 no.1 pp. 62
ISSN:
1746-6148
Subject:
monoclonal antibodies,   etc   ; Camelus dromedarius; adults; calves; camels; flow cytometry; humans; monocytes; neonates; phenotype;     Show all 10 Subjects
Abstract:
... BACKGROUND: In human and different animal species, blood monocytes are classified based on their expression pattern of different monocytic markers into phenotypically and functionally different subsets. In the current study, we used flow cytometry and monoclonal antibodies to CD172a, CD14, CD163 and MHCII to identify monocyte subsets in peripheral blood of dromedary camels. RESULTS: Based on CD14, ...
DOI:
10.1186/s12917-020-02285-8
PubMed:
32070351
PubMed Central:
PMC7027094

15. Precise location of linear epitopes on the capsid surface of feline calicivirus recognized by neutralizing and non-neutralizing monoclonal antibodies

Author:
Cubillos-Zapata, Carolina; Angulo, Iván; Almanza, Horacio; Borrego, Belén; Zamora-Ceballos, María; Castón, José R.; Mena, Ignacio; Blanco, Esther; Bárcena, Juan
Source:
Veterinary research 2020 v.51 no.1 pp. 59
ISSN:
1297-9716
Subject:
monoclonal antibodies,   etc   ; Feline calicivirus; amino acids; capsid; coat proteins; epitope mapping; epitopes; neutralization; viral antigens;     Show all 9 Subjects
Abstract:
... We report the generation, characterization and epitope mapping of a panel of 26 monoclonal antibodies (MAbs) against the VP1 capsid protein of feline calicivirus (FCV). Two close but distinct linear epitopes were identified at the capsid outermost surface (P2 subdomain) of VP1, within the E5′HVR antigenic hypervariable region: one spanning amino acids 431-435 (PAGDY), highly conserved and recogniz ...
DOI:
10.1186/s13567-020-00785-x
PubMed:
32357948
PubMed Central:
PMC7195702

16. Implementing PAT for single-pass tangential flow ultrafiltration for continuous manufacturing of monoclonal antibodies

Author:
Thakur, Garima; Thori, Swapnil; Rathore, Anurag S.
Source:
Journal of membrane science 2020 v.613 pp. 118492
ISSN:
0376-7388
Subject:
monoclonal antibodies,   etc   ; algorithms; artificial membranes; case studies; cleaning; empirical models; manufacturing; monitoring; near-infrared spectroscopy; ultrafiltration;     Show all 10 Subjects
Abstract:
... Control of single pass tangential flow ultrafiltration is crucial for continuous manufacturing of monoclonal antibodies. We propose a strategy to control the output concentration of a continuous ultrafiltration step regardless of variations in the volume or concentration of the feed material. Scheduling algorithms for the filtration runs and cleaning cycles are developed, accounting for the expect ...
DOI:
10.1016/j.memsci.2020.118492

17. Colloidal gold-based immunochromatographic strip assay for the rapid detection of bacitracin zinc in milk

Author:
Na, Guanqiong; Hu, Xiaofei; Yang, Jifei; Sun, Yaning; Kwee, Sharon; Tang, Liang; Xing, Guangxu; Xing, Yunrui; Zhang, Gaiping
Source:
Food chemistry 2020 v.327 pp. 126879
ISSN:
0308-8146
Subject:
monoclonal antibodies,   etc   ; bacitracin; detection limit; immunoaffinity chromatography; inhibitory concentration 50; mice; milk; monitoring; rapid methods; zinc;     Show all 10 Subjects
Abstract:
... In this study, a murine monoclonal antibody (mAb) of 6D2-G10 against bacitracin zinc (BAC) was produced and applied to an immunochromatographic strip (ICS) for the initial detection of BAC in milk. The ICS with a cut-off value of 25 ng/mL could be perceived by the naked eye within 10 min. With the assist of the strip reader, the limit of detection (LOD) was measured as 0.82 ng/mL, the half-maximal ...
DOI:
10.1016/j.foodchem.2020.126879

18. Continuous Fc detection for protein A capture process control

Author:
Patil, Ujwal; Crum, Mary; Vu, Binh; Wasden, Katherine; Kourentzi, Katerina; Willson, Richard C.
Source:
Biosensors & bioelectronics 2020 v.165 pp. 112327
ISSN:
0956-5663
Subject:
monoclonal antibodies,   etc   ; adsorbents; biosensors; cell culture; fluorescence; humans; immunoglobulin G; ligands; monitoring; process control; therapeutics;     Show all 11 Subjects
Abstract:
... Purification of therapeutic monoclonal antibodies usually involves a protein A affinity capture step. Because column breakthrough of antibody in complex, UV-absorbing culture fluid cannot be readily detected in real time, processes are designed so conservatively that column capacity is usually underutilized, wasting adsorbent and reducing productivity. We have developed a fluorescence-based monito ...
DOI:
10.1016/j.bios.2020.112327

19. All systems go: converging synthetic biology and combinatorial treatment for CAR-T cell therapy

Author:
Lanitis, Evripidis; Coukos, George; Irving, Melita
Source:
Current opinion in biotechnology 2020 v.65 pp. 75-87
ISSN:
0958-1669
Subject:
monoclonal antibodies,   etc   ; Adenoviridae; T-lymphocytes; antigens; drug therapy; neoplasms; radiotherapy; synthetic biology; vaccines;     Show all 9 Subjects
Abstract:
... Synthetic biology has been transformative to the treatment of advanced hematological malignancies by chimeric antigen receptor (CAR)-engineered T cells. A range of obstacles are now understood to limit the responses of solid epithelial-derived tumors to CAR therapy. For example, inefficient tumor homing and a fortified stroma can restrain the number of CAR-T cells reaching the tumor bed. Upon tran ...
DOI:
10.1016/j.copbio.2020.01.009

20. Enhancing the stability of adalimumab by engineering additional glycosylation motifs

Author:
Reslan, Mouhamad; Sifniotis, Vicki; Cruz, Esteban; Sumer-Bayraktar, Zeynep; Cordwell, Stuart; Kayser, Veysel
Source:
International journal of biological macromolecules 2020 v.158 pp. 189-196
ISSN:
0141-8130
Subject:
monoclonal antibodies,   etc   ; antigens; binding capacity; engineering; glycosylation; half life; immunogenicity; melting point; mutation; neoplasms; receptors; therapeutics;     Show all 12 Subjects
Abstract:
... Monoclonal antibodies (mAbs) are of high value in the diagnostic and treatment of many debilitating diseases such as cancers, auto-immune disorders and infections. Unfortunately, protein aggregation is one of the ongoing challenges, limiting the development and application of mAbs as therapeutic products by decreasing half-life, increasing immunogenicity and reducing activity. We engineered an agg ...
DOI:
10.1016/j.ijbiomac.2020.04.147