Keywords: Industry 4.0; In silico; Computer model; Digital twin; Tissue engineering; ATMP; Advanced Therapeutic Medicinal Product; ASME; American Society of Mechanical Engineers; CAD-CAM; Computer Aided Design - Computer Aided Manufacturing; cBiT; compendium for
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Keywords: API; active pharmaceutical ingredient; CP; centerpoint; CQA; critical quality attribute; DOE; design of experiments; MBPH; main-compression bottom punch height; MCC; microcrystalline cellulose; MCD; main-compression displacement; MCF; main compression for
Keywords: CQA; Question retrieval; Deep learning; Social network;
Keywords: Biotherapeutics; Gene and cell therapy; Pharmacokinetics; Non-clinical safety; Immunogenicity; Cross-reactive species; ATMP; advanced therapy medicinal products; CAR; chimeric antigen receptor; CD; cluster of differentiation; CMC; chemistry manufacturing
Keywords: protein formulation; multivariate analysis; biotechnology; stability; excipients; formulation; quality by design; protein excipient interactions; pharmaceutical sciences; biopharmaceuticals characterization; L-Histidine (PubChem CID: 6274); L-Histidine hy
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: AMMS; accurate mass spectrometry; AQbD; analytical quality-by-design; ASME; American Society of Mechanical Engineers; ATP; analytical target profile; CQA; critical quality attributes; DoE; design of experiments; DQ; design qualification; DS; design space;
Keywords: Metabolic flux analysis; Sensitivity analysis; Complex raw material; Filamentous fungi; Corn steep liquor; Key material attributes; ACV; L-α-aminoadipyl-L-cysteinyl-D-valine; CMA; critical material attributes; CPP; critical process parameters; CQA; criti
Keywords: Recombinant therapeutics; Aggregation; Host cell proteins; Glycosylation; Regulation; Biopharmaceuticals; 2D-PAGE; Two-dimensional polyacrylamide gel electrophoresis; ADCC; antibody-dependent cell-mediated cytotoxicity; AUC/SV-AUC; (Sedimentation velocity
Keywords: Nanomedicines; Nanosimilars; NBCDs; CQA; Regulation in the US and the EU; Scientific stakeholder exchange;
Keywords: CQA; Cross-source; Cold-start; Multi-view learning;
Keywords: Nanocrystals; (Nano-)cocrystals; Characterization; Solid state; Drug release; Particle size; CQA; Critical quality attributes;
Keywords: CCCD; circumscribed central composite design; CQA; critical quality attribute; DOE; design of experiments; QbD; quality-by-design; 3-Fluid nozzle; Design of experiments; Dissolution rate; Lipophilic drug; Poor water solubility; Solid dispersion; Spray dry
Keywords: BB; bilobalide; CE; collision energy; CPP; critical process parameter; CQA; critical quality attribute; CXP; collision cell exit potential; DMSO; dimethylsulfoxide; DP; declustering potential; EP; injection voltage; ESIâ; negative ionization mode; FMEA;
Keywords: Coffea arabica; Green seed residue; Agroindustrial residue; Antioxidant; Secondary metabolites; 5-CQA; 5-caffeoylquinic acid; AAPH; 2,2â²-azobis(2-methylpropionamidine) dihydrochloride; ABTS+; diammonium salt of 2,2â²-azino-bis(3-ethylbenzothiazoline-6-
Keywords: Asp-N; endoproteinase AspN; BLA; biologics license application; CDR; complementarity determining region; CFR; Code of Federal Regulations; CGF; carboxyl group footprinting; cGMP; current good manufacturing practice; CHO; Chinese hamster ovary; CID; collis
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
Design of a strong cation exchange methodology for the evaluation of charge heterogeneity in glatiramer acetate
Keywords: % RTR; Retention Time Ratio Percent; ATP; Analytical Target Profile; CQA; Critical Quality Attribute; CV; Coefficient of Variation; GA; Glatiramer Acetate; ICH; The International Conference on Harmonisation of Technical Requirements for Registration of Ph
Keywords: API; active pharmaceutical ingredient; CPP; critical process parameter; CQA; critical quality attribute; D; diameter of the extruder screws; DOE; design of experiments; GSD; granule size distribution; IQR; interquartile range; L/S-ratio; liquid to solid r
Keywords: NIRS; near infrared spectroscopy; PAT; process analytical technology; TDS; transdermal drug delivery systems; NIR; near infra-red; CQA; critical quality attribute; PLS; partial least square; %PE; % prediction error; MCT; mercury-cadmium-telluride; MC; Mea
Keywords: aAPC; artificial APC; ACT; adoptive cell therapy; CDM; chemically defined media; cGMP; current Good Manufacturing Practices; DC; dendritic cell; CPP; critical process parameter; CQA; critical quality attribute; FACS; fluorescence activated cell sorting; H
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
Identification and characterization of monoclonal antibody fragments cleaved at the complementarity determining region using orthogonal analytical methods
Keywords: CE-SDS; sodium dodecyl sulfate capillary electrophoresis; mAb; monoclonal antibody; RP-LC-MS; reversed phase liquid chromatography mass spectrometry; CDR; complementarity determining region; SEC-HPLC; size exclusion liquid chromatography; dSEC-HPLC; d
Keywords: ANN; artificial neural networks; API; active pharmaceutical Ingredient; CFD; computational fluid dynamics; CMA; critical material attribute; CQA; critical quality attribute; CPP; critical process parameter; DEM; discrete element Method; DoDE; design of dy
Keywords: AE; Acoustic Emission; ANN; Artificial Neural Networks; API; Active Pharmaceutical Ingredient; BET; Brunauer-Emmett-Teller; CFD; Computational Fluid Dynamics; CIP; Constrained Interpolation Profile; CQA; Critical Quality Attributes; DEM; Discrete Elem
Keywords: continuous manufacturing; direct compression; control strategy; state of control; statistical process control; process capability; CM; continuous manufacturing; Cpk; process capability index; CQA; critical quality attributes; CU; content uniformity; DC; d
Keywords: biotechnology; formulation; HPLC; multivariate analysis; oxidation; factorial design; protein aggregation; protein formulation; proteins; stability; AC; acceptance criterion; Buff; buffer concentration; CQA; critical quality attribute; CI; confidence inte
Keywords: CGA; chlorogenic acid; CGA eq.; chlorogenic acid equivalents; CQA; caffeoylquinic acid; HMF; hydroxymethylfurfural; HC_H; high concentrated hydrolysate; LC_H; low concentrated hydrolysate; HC_S; high concentrated slurry; LC_S; low concentrated slurry; L/S
Keywords: CGAs; chlorogenic acids; GCB; green coffee beans; RC; roasted coffee; SS; coffee silver-skins; dSS; silver-skins from decaffeinated green coffee beans; SC; spent coffee; SCe; spent coffee from espresso machines waste; DPPH; 2,2-diphenyl-1-picrylhydrazyl;
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: BM-hMSC; bone marrow derived human mesenchymal stem cells; MNC; mononuclear cells; FBS; fetal bovine serum; DMSO; dimethylsulphoxide; CFU-f; colony forming unit fibroblast; QC; quality control; QA; quality assurance; STR; short tandem repeat; CQA; critica
Keywords: API; active pharmaceutical ingredient; Cmax; maximum plasma concentration; CQA; critical quality attribute; CPP; critical process parameter; EMA; European Medicines Agency; FDA; U.S. Food and Drug Administration; FPF; fine particle fraction; ICH; Internat
Keywords: CQA; Question and answer; Voting correlation; Voting prediction
Keywords: Calcium hydrogen phosphate (PubChem CID: 24441); CED; circle equivalent diameter; CQA; critical to quality attribute; GMP; good manufacturing practice; MVA; multivariate data analysis; PSD; particle size distribution; Pharmaceutical excipients; Process an
Keywords: Design space; Process robustness; Ethanol precipitation; Danhong injection; Quality by design; AC; active ingredient content (mg gâ1); ACR; active ingredient recovery (%); AEA; the amount of ethanol added (mL gâ1); ANOVA; analysis of variance; ARD;
Q-marker based strategy for CMC research of Chinese medicine: A case study of Panax Notoginseng saponins
Keywords: Q-marker; Chinese medicine; CMC; PNS; Manufacture processes; Q-marker; quality-marker; CM; Chinese medicine; PNS; Panax Notoginseng Saponins; CMC; chemistry, manufacturing and control; CQA; critical quality attribute; CPP; critical process parameter; ANN;
Glycosimilarity assessment of biotherapeutics 1: Quantitative comparison of the N-glycosylation of the innovator and a biosimilar version of etanercept
Keywords: APTS; 8-aminopyrene-1,3,6-trisulfonic acid; CGE-LIF; capillary gel electrophoresis - laser induced fluorescence; CQA; critical quality attributes; ADCC; antibody-dependent cell-mediated cytotoxicity; CDC; complement-dependent cytotoxicity; Fc; fragment
Development of TCM-based composite particles for direct compaction by particle design
Keywords: Direct compaction; Design of experiment; Compactibility; Flowability; Yield; Traditional Chinese medicine; AHE; Andrographis herba extract; API; active pharmaceutical ingredient; AR; angle of repose; AUTCC; area under the tensile strength versus compactio
Hot-melt coating with Precirol ATO 5 in a fluidized-bed apparatus: Application of experimental design in the optimization of process parameters
Keywords: Granules; Paracetamol; Glycerol distearate; Size distribution; Flowability; Drug release; AAP; atomization air pressure; AUC; area under the drug release curve; BCS; Biopharmaceutics Classification System; CI; compressibility index; CPP; critical process
Nanopharmaceuticals for wound healing - Lost in translation?
Keywords: Nanomaterials; Biomaterials; Advanced wound healing therapies; Current regulatory perspective; ASTM; American Society for Testing and Materials; CQA; critical quality attributes; ECM; extracellular matrix; EGF; epidermal growth factor; EMA; European medic
Centella asiatica attenuates Aβ-induced neurodegenerative spine loss and dendritic simplification
Keywords: CAW; water extract of Centella asiatica; AD; Alzheimer's disease; CQA; caffeoylquinic acid; IsoA; isocholorogenic acid A; 1,5diCQA; 1,5-dicaffeoylquinic acid; CHLA; chlorogenic acid; AA; asiatic acid; AS; asiaticoside; MA; madecassic acid; MS; madecasssos
Evaluation of Asteraceae herbal extracts in the management of diabetes and obesity. Contribution of caffeoylquinic acids on the inhibition of digestive enzymes activity and formation of advanced glycation end-products (in vitro)
Keywords: Asteraceae plants; Caffeoylquinic acids; Hyperglycaemia; Digestive enzymes inhibition; Advanced glycation end-products; AGEs; advanced glycations end-products; AMG; aminoguanidine; ANOVA; analysis of variance; BSA; bovine serum albumin; CQA; caffeoylquini
Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): An improved dermatokinetic profile for inflammatory disorder(s)
Keywords: NLCs; Nanostructured lipid carriers; SLNs; Solid lipid nanoparticles; CA; Cetyl alcohol; QbD; Quality by Design; FbD; Formulation by Design; CQA; Critical Quality Attributes; CMA; Critical Material Attributes; CFA; Critical Formulation Attributes; Opt; Op
Natural lipids enriched self-nano-emulsifying systems for effective co-delivery of tamoxifen and naringenin: Systematic approach for improved breast cancer therapeutics
Keywords: SNEDDS; Self-nano-emulsifying drug delivery systems; Smix; Surfactant mix; TMX; Tamoxifen; NG; Neringenin; PUFA; Polyunsaturated fatty acids; GIT; Gastrointestinal tract; Opt; Optimized; QbD; Quality by design; DoE; Design of experiment; CQA; Critical qua
Lyophilized Drug Product Cake Appearance: What Is Acceptable?
Keywords: lyophilization; processing; freeze drying; protein formulation; drying; formulation; glass transition; stability; amorphous; CQA; critical quality attribute; Tc; collapse temperature; Tgâ²; glass transition temperature of the maximally freeze-concentrate
Assessing analytical comparability of biosimilars: GCSF as a case study
Keywords: CQA; critical quality attributes; GCSF; granulocyte colony stimulating factor; CD; circular dichroism spectroscopy; RPC; reverse phase chromatography; SEC; size exclusion chromatography; FLD; fluorescence detector; mAbs; monoclonal antibodies; PTM; post t
Performance review of a fast HPLC-UV method for the quantification of chlorogenic acids in green coffee bean extracts
Keywords: 3-CQA; 3-Caffeoyquinic Acid; 3,4-diCQA; 3,4-Dicaffeoylquinic Acid; 3,5-diCQA; 3,5-Dicaffeoylquinic Acid; 4-CQA; 4-Caffeoyquinic Acid; 4,5-diCQA; 4,5-Dicaffeoylquinic Acid; 5-CQA; 5-Caffeoyquinic Acid; 5-FQA; 5-Feruloylquinic Acid; CGA; chlorogenic acids;
Optimization of a pharmaceutical tablet formulation based on a design space approach and using vibrational spectroscopy as PAT tool
Keywords: AA; average assay; API; active pharmaceutical ingredient; AV; acceptance value; CI; Carr index; CMA; critical material attribute; CQA; critical quality attribute; CU; content uniformity; DHI; distributional homogeneity index; DoE; design of experiments; H
Metabolic profiling of antioxidants constituents in Artemisia selengensis leaves
Keywords: AST; Artemisia selengensis Turcz; HPLC-QTOF-MS2; high-performance liquid chromatography equipped with diode array detector, electrospray ionization and quadruple/time-of-flight tandem mass spectrometry; TPC; total phenolics content; TFC; total flavonoids
Optimization of Panax notoginseng extraction process using a design space approach
Keywords: AEA; amount of ethanol added (mL/g); ANOVA; analysis of variance; ARD; average relative deviation (%); C; saponin concentration; Cal; calculated values; CPP; critical process parameter; CQA; critical quality attribute; DM; the dry matter content of an ext