Keywords: Embryo-fetal development; Biopharmaceutical; Developmental toxicity; Pregnancy; Teratogen;
مقالات ISI (ترجمه نشده)
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در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
Keywords: 2D-LC; Two Dimensional Liquid Chromatography; ADC; Antibody Drug Conjugate; AEX; Anion Exchange Chromatography; BEH; Bridged Ethylene Hybrid (hybrid silica); BSA; Bovine Serum Albumin; BsAb; Bispecific Antibody; CQA; Critical Quality Attribute; EMA; Europ
Keywords: salt; solubility; stability; biopharmaceutical; poorly water soluble; solution phase; solid phase; equilibrium; pKa; pH; AB; acetate buffer; ACN; acetonitrile; API; active pharmaceutical ingredient; BS; benzoate salt; CB; citrate buffer; DSC; differential
Keywords: robustness; quality by design; biopharmaceutical; drug product; formulation; manufacturing process; design space; BLA; biological license application; BPDG-FPS; Biophorum Development Group-Formulation Point Share; CQA; critical quality attribute; CPP; c
A new polymorph of ciprofloxacin saccharinate: Structural characterization and pharmaceutical profile
Keywords: Polymorph; Salt; Ciprofloxacin; Biopharmaceutical; Dissolution; Antibacterial;
Keywords: Protein purification; Downstream process; Biopharmaceutical; Anything but chromatography; Crystallization; Precipitation;
Keywords: Strategic alliances; Biopharmaceutical; Commercialization; Performance;
Keywords: Licensing; Biopharmaceutical; Patents; Licensing speed; Royalty rates; Innovation;
Comparability study of Rituximab originator and follow-on biopharmaceutical
Keywords: AA; amino acid; ABC; ammonium bicarbonate; ACN; acetonitrile; ADCC; antibody-dependent cellular cytotoxicity; CD; circular dichroism; CDC; complement-dependent cytotoxicity; CDRs; complementarity determining regions; CH; constant region of heavy chain; CH
Keywords: dual-chamber systems; dual-chamber cartridge; dual-chamber syringe; biologics; freeze-drying; aseptic processing; biopharmaceutical; small volume parenterals; home care; fixed dose combination;
Keywords: Biopharmaceutical; Bioscavenger; Cholinesterase; Nerve agent; Organophosphorus compound; Paraoxonase; Phosphotriesterase; AChE; acetylcholinesterase; BChE; butyrylcholinesterase; CaE; carboxylesterase; CSP; cresyl saligenyl phosphate; DFP; diisopropylfluo
Keywords: Peptide mapping; Comparability; Higher-order structure; Biopharmaceutical; Circular dichroism; Mass spectrometry; ADC; antibody drug conjugate; F(ab)2; divalent fragment antigen binding; Fab; monovalent fragment antigen binding; mAb1-deg; deglycosylated m
Keywords: 2D-LC; two-dimensional liquid chromatography; AA; amino acid; AC; affinity chromatography; ADC; antibody-drug conjugates; ADCC; antibody-dependent cellular cytotoxicity; AF4; asymmetric flow field fractionation; APTS; 1-aminopyrene-3,6,8-trisulfonate; Asn
Keywords: Protein separation; Biopharmaceutical; Cell cultures; Chromatography resins
Keywords: rhINF-γ; recombinant human Interferon gamma; PEG 4000; Polyethylene glycol 4000; HCP; host cell proteins; HTP-techniques; high throughput techniques; UV280; ultraviolet light with a wavelength of 280 nm; Phase diagram; Solubility curve; Cytokine; Crysta
Keywords: Biopharmaceutical; Biosimilar; Capillary electrophoresis coupled to mass spectrometry (CE-MS); Glycomics; Glycoproteomics; Glycosylation Critical Quality Attributes (GCQA); Liquid chromatography coupled to mass spectrometry (LC-MS); Matrix-assisted laser
Keywords: Protein drying; Ultrafiltration membrane; Thin film; Monoclonal antibody; Biopharmaceutical
Keywords: Biopharmaceutical; Biosimilar; Darbepoetin alfa; Epoetin; Glycan; Glycomic characterization; Glycopeptide; Glycosylation; Mass spectrometry; Recombinant erythropoietin;
Keywords: Particulate matter; Particle; Protein; Biopharmaceutical; In-line filtration; Immunogenicity;
Keywords: HCP; Mass spectrometry; Comparability; Biopharmaceutical
Keywords: Biopharmaceutical; Characterization; Hydrophilic interaction chromatography (HILIC); Ion-exchange chromatography (IEX); Mass spectrometry (MS); Monoclonal antibody (mAb); Reversed-phase liquid chromatography (RPLC); Size-exclusion chromatography (SEC); Th
Keywords: Compression; Freeze-drying; Biopharmaceutical; Elastic modulus; Crushing strength; Structure; Cake; Mechanics model; Sucrose
Keywords: Biopharmaceutical; Innovation; Logic; Net; Network;
Keywords: Acute kidney injury; alkaline phosphatase; biopharmaceutical; adenosine; sepsis; hypoxia; renal inflammation; renal failure; systemic inflammation;
Keywords: Chromatography; Mass spectrometry; Biopharmaceutical; Monoclonal antibody; Therapeutic protein
MS-based conformation analysis of recombinant proteins in design, optimization and development of biopharmaceuticals
Keywords: Biopharmaceutical; Antibody; Higher order structure; Native mass spectrometry; Hydrogen/deuterium exchange; Oxidative footprinting;
PASylation®: A versatile technology to extend drug delivery
Keywords: Biobetter; Biological drug; Biopharmaceutical; Kidney filtration; PASylation; PEGylation; Plasma half-life; Renal elimination; XTEN;
Characterization of therapeutic antibodies and related products by two-dimensional liquid chromatography coupled with UV absorbance and mass spectrometric detection
Keywords: Protein; Biopharmaceutical; Monoclonal antibody; Antibody-drug conjugate; Two-dimensional liquid chromatography; Mass spectrometry;
A scalable low-cost cGMP process for clinical grade production of the HIV inhibitor 5P12-RANTES in Pichia pastoris
Keywords: Pichia; Yeast; Process development; Chemokine; HIV; Microbicide; CCR5; 5P12-RANTES; Biopharmaceutical; cGMP;
Phase 1 clinical study with Bioneedles, a delivery platform for biopharmaceuticals
Keywords: Bioneedle; Polymer; Starch; Clinical trial; Delivery platform; Biopharmaceutical
A structural approach to the HAZOP - Hazard and operability technique in the biopharmaceutical industry
Keywords: HAZOP; Risk assessment; Hazard; Safety; Deviations; Biopharmaceutical;
Current and future trends in UHPLC
Keywords: Bioanalysis; Biopharmaceutical; Fast analysis; Fully porous particle; High-resolution analysis; HILIC; Metabolomics; Superficially porous particle; UHPLC; UHPLC-MS;
Identification of a novel endogenous regulatory element in Chinese hamster ovary cells by promoter trap
Keywords: Promoter trap; Endogenous promoter; Chinese hamster ovary cells; Expression system; Biopharmaceutical
Tackling the increasing complexity of therapeutic monoclonal antibodies with mass spectrometry
Keywords: Analytical method; Antibody (Ab); Antibody-drug conjugate (ADC); Biopharmaceutical; Biosimilar; Bispecific antibody; Glycosylation; Mass spectrometry; Native mass spectrometry; Sequence variant
Top-down characterization of biopharmaceuticals
Keywords: Biopharmaceutical; Biosimilar; Deamidation; Fragmentation; Glycoprotein; Glycosylation; Ionization; Mass spectrometry (MS); Protein characterization; Top-down analysisCID, Collision-induced dissociation; ESI, Electrospray ionization; FT-ICR, Fourier trans
Metabolism and metabolic burden by α1-antitrypsin production in human AGE1.HN cells
Keywords: Mammalian cell; Cell culture; Biopharmaceutical; Metabolic flux; AAT deficiency; Therapeutic protein
An environmental life cycle assessment comparison of single-use and conventional process technology for the production of monoclonal antibodies
Keywords: Monoclonal antibody; Biopharmaceutical; Single-use; Disposable; Bioreactor; Life cycle assessment; LCA; Process train; Clean-in-place; Steam-in-place; CIP/SIP
Therapeutic antibodies: Market considerations, disease targets and bioprocessing
Keywords: Monoclonal antibody; Market; Oncology; Immune disorder; Biopharmaceutical; Bioprocessing
Embryo-fetal distribution of a biopharmaceutical IgG2 during rat organogenesis
Keywords: Placental transfer; Biodistribution; Monoclonal antibodies; Biopharmaceutical; IgG
Extraction, purification and characterization of the plant-produced HPV16 subunit vaccine candidate E7 GGG
Keywords: CD; circular dichroism; CIN; cervical intraepithelial neoplasia; CV; column volume; DCs; dendritic cells; DTT; dithiothreitol; ESI; electro spray ionization; HIC; hydrophobic interaction chromatography; HPV; human papillomavirus; IEC; ion exchange chromat
Metabolic flux rearrangement in the amino acid metabolism reduces ammonia stress in the α1-antitrypsin producing human AGE1.HN cell line
Keywords: Mammalian cell; Therapeutic protein; AAT deficiency; Nitrogen metabolism; Biopharmaceutical; Metabolic flux analysis
Fragmentation hydrogen exchange mass spectrometry: A review of methodology and applications
Keywords: Hydrogen exchange; Mass spectrometry; Protein interaction; Ligand; Folding; Biopharmaceutical
Industrial-scale manufacturing of pharmaceutical-grade bioactive peptides
Keywords: Bioactive peptides; Biopharmaceutical; Drugs; Bioprocessing; Scale-up
Data analysis in stability studies of biopharmaceutical drugs with isothermal and non-isothermal assays
Keywords: Arrhenius; Biopharmaceutical; Bootstrap; Data analysis; Isothermal assay; Non-isothermal assay; Peptide; Protein; Regression method; Stability
A special report on India's biotech scenario: Advancement in biopharmaceutical and health care sectors
Keywords: India; Biotechnology; Biopharmaceutical; Health care; Therapeutics; Diagnostics
Evaluation of a combinatorial cell engineering approach to overcome apoptotic effects in XBP-1(s) expressing cells
Keywords: Cell engineering; CHO; Biopharmaceutical; Mammalian; Fed-batch; Cell culture; XBP-1; XIAP; Apoptosis
Gene amplification and vector engineering to achieve rapid and high-level therapeutic protein production using the Dhfr-based CHO cell selection system
Keywords: Biopharmaceutical; Amplification; Methotrexate; Expression; Enhancers
Analysis of adsorption of a baculovirus bioreaction bulk on an ion-exchange surface by surface plasmon resonance
Keywords: Surface plasmon resonance; Ion-exchange chromatography; Scaled-down model for process development; Predictive modeling; Baculovirus; Biopharmaceutical
Removal of B cell epitopes as a practical approach for reducing the immunogenicity of foreign protein-based therapeutics
Keywords: Deimmunization; Mutagenesis; Antigen; Antigenicity; Antibody; Biopharmaceutical
Physicochemical and biological assays for quality control of biopharmaceuticals: Interferon alfa-2 case study
Keywords: Interferon; Bioassay; Dynamic light scattering; Biopharmaceutical; qRT-PCR