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NOVARTIS GLOSSRIO DE CROMATOGRAFIA TERMO 20 EU/mL standard CSE stock solution 2-nitro-5-thiobenzoic acid (TNB) 5,5'-dithiobis-(2-nitrobenzoic acid) (DTNB;

Ellman's reagent) 96-well plate Absorbance at 450 nm (A450) Acceptance criterion acidic peak Acrylonitrile (ACN) Affinity chromatography Aggregation albIFN bulk sample albIFN size purity albumin-interferon-alpha (albIFN) American Chemical Society (ACS) Antilog antiproliferation bioassay Aromatic side chains Assay plate Average result averaged final result Back-calculation Background subtraction be too numerous to count (TNTC) Bench vacuum line Bioburden black matte panel Bovine Serum Albumin (BSA) bulk drug substance solution (BDS) Butterfly overlay Capillary Capillary electrophoresis (CE) capillary gel electrophoresis Capillary isoelectric focusing using a Beckman CE system Cell passivation and cleaning solution Charge heterogeneity TRADUO Soluo estoque da CSE padro de 20 EU/mL 2-nitro-5-cido tiobenzico (TNB) 5,5'-ditiobis-(2-cido nitrobenzico) (DTNB; reagente de Ellman) Placa com 96 poos Absoro a 450 nm (A450) Critrio de aceitao Pico de cido Acrilonitrilo (ACN) Cromatografia de afinidade Agregao amostra de albIFN a granel pureza do albIFN albumina-interferon alfa (albIFN) American Chemical Society [Sociedade Norte-americana de Qumica (ACS)] Antilog bioensaio de anti-proliferao Cadeias laterais aromticas Placa de ensaio Resultado mdio Resultado final ponderado Retroclculo Subtrao do fundo Demasiadamente numerosas para se contar (TNTC) Linha a vcuo da bancada Carga biolgica painel preto fosco Albumina srica bovina (BSA) soluo do princpio ativo a granel (BDS) Camada borboleta [butterfly overlay] Capilar eletroforese capilar (EC) Eletroforese capilar em gel Focalizao isoeltrica capilar utilizando um sistema EC Beckman soluo de limpeza e passivao de clula Heterogeneidade da carga

Clarity Clear to opalescent Clip Clipping Coefficient of variation (CV) Collapse of cake color reference solution Column carry over column conditioning Compendial method constrained 4-parameter logistic curves Control Standard Endotoxin (CSE) Corrected percent area Correlation coefficient Cysteinylation content Deamidation degree of coloration test Differential Scanning Calorimetry digestion buffer diluted unmodified rabbit anti-HCP antiserum Dinitrothiocyanobenzene (DTNB) Diode array detector Effective Concentration (EC) Electrospray Ionization Mass Spectrometry Empty sample compartiment Enzyme Linked Immunosorbent Assay (ELISA) Equilibration step Estimates of X extinction coefficient Extrapolated value Far-UV and Near-UV Circular Dichroism Spectroscopy Final drug product (FDP) Flow rate Fluid Thioglycollate Medium Fluorescence Spectroscopy Forced degradation studies Foreign particulate matter Formulation buffer

Transparncia Claro a opalescente Clipe Clipagem Coeficiente de variao (CV) Reduo/Encolhimento do bolo (liofilizado) soluo de referncia de cor Transporte da coluna Acondicionamento da coluna Mtodo compendioso curvas logsticas restritas com 4 parmetros Endotoxina padro de controle (CSE) rea percentual corrigida Coeficiente de correlao Teor de cisteinilao Desamidao Teste do grau de colorao calorimetria diferencial de varredura tampo de digesto anti-soro anti-HCP de coelho no modificado e diludo Dinitrotiocianobenzeno (DTNB) Detector de arranjo de diodo Concentrao Eficaz (EC) Espectrometria de massa com ionizao por electrospray Compartimento vazio de amostra Ensaio Imunosorvente Ligado Enzima (ELISA) Etapa de equilbrio Estimativas de X Coeficiente de extino Valor extrapolado Espectroscopia de dicroismo circular na regio do UV-distante e do UV-prximo Medicamento final (FDP) Vazo Meio fluido tioglicolato Espectroscopia por fluorescncia Estudos de degradao forada Material estranho particulado Frmula tampo

Free thiol gel-clot method Glucation Glycation Goat anti-yeast HCP capture antibody Gradient cicle High Performance Liquid Chromatogram (HPLC) Human Serum Albumin (HSA) Identity Inhibitory concentration (IC) Instrument software In-use stability studies Ion-exchange HPLC (IE-HPLC) Isocratic conditions Laboratory turbidimeter LAL reagent LAL Reagent Water (LRW) Limulus Amebocyte Lysate (LAL) Linear fit linear regression coefficient lowest specified protein concentration Ls-g*(s) Profile and Weight Average Sedimentation Coefficient Determination by Sedimentation Velocity Analysis M16/M13/... process Main peak Mass spectrometry (MS) Matrix-assisted Laser Desorption/ionization Maximum Valid Dilution (MVD) Mean % Accuracy Meltback of cake Metal Catalyzed Oxidation (MCO) Methods and Instrument Data Analysis System (MIDAS) Microflow Imaging (MFI) microtiter plate reader Midpoint Milli Q Water Minimum Valid Concentration (MVC)

Tiol livre Mtodo de cogulo de gel Glicao Glicao Anticorpo de captura de HCP antilevedura de cabra Ciclo de gradiente Cromatografia lquida de alta eficincia (HPLC) Albumina Srica Humana (HSA) Identidade Concentrao inibidora (IC) Software do instrumento Estudos de estabilidade em uso HPLC de troca inica (IE-HPLC) Condies isocrticas Turbidmetro laboratorial Reagente LAL gua Reagente LAL (LRW) lisado de amebcito de Limulus (LAL) Ajuste linear Coeficiente de regresso linear concentrao protica mais baixa especificada Determinao do perfil Ls-g*(s) e do coeficiente mdio ponderado da sedimentao por anlise da velocidade de sedimentao Processo M16/13/... Pico principal Espectometria de massa (MS) Dessoro/ionizao a laser assistida por matriz Diluio Mxima Vlida (MVD) Preciso % mdia Sublimao incompleta Oxidao catalisada por metal (MCO) Methods and Instrument Data Analysis System [Sistema de Anlise de Dados de Instrumentos e de Mtodos (MIDAS)] Imagem do micro-fluxo (MFI) Leitor de placa microtituladora Ponto mdio (da curva padro) gua Milli Q Concentrao Mnima Vlida (MVC)

molecular sieving technique Monothioglycerol (MTG) N-Acetyl Cysteine (NAC) native conditions negative control replicate Nephelometric Turbidity Unit (NTU) N-terminal sequencing optimal dilution factor Path length Peptide mapping pH buffer phosphate-buffered saline (PBS) Photostability Plate Plate shaker polymerase chain reaction (PCR) Pooled slope Potassium phosphate monobasic Pour plate method Product gene Production plasmid Protein peak Quality control-microbiology (QCMicrobiology) Quantitation of albIFN size purity by Sedimentation Velocity Analysis Quantitation of Breox in albIFN Samples Quantitation of Yeast Host Cell Proteins in albIFN In-Process Samples by ELISA Reactive mixture Read out reduced and non-reduced condition Reduced and non-reduced reference standard Regression coefficient relative standard deviation (RSD) release analytical methods replicate relative potency Residual albIFN Residual Yeast Host Cell Protein

tcnica de peneiramento molecular Monotioglicerol (MTG) N-Acetil Cistena (NAC) Condies nativas rplica do controle negativo Unidade Nefelomtrica de Turbidez (NTU) Seqenciamento N-terminal fator de diluio ideal extenso da trajetria Mapeamento peptdico Tampo de pH soluo salina tamponada com fosfato (PBS) Fotoestabilidade Placa Agitador de placa Reao em cadeia da polimerase (PCR) Declive agrupado fosfato de potssio monobsico Mtodo de placa de cultura Produto gnico Plasmdio da produo Pico de protena controle de qualidade em microbiologia Quantificao da pureza do albIFN por anlise da velocidade de sedimentao Quantificao de Breox nas amostras de albIFN Quantificao das protenas da clula hospedeira de levedura em amostras de albIFN em processamento por ELISA Mistura de reao Dados condies reduzidas e no reduzidas Padro de referncia reduzido e no reduzido Coeficiente de regresso Desvio padro relativo (RSD) mtodos analticos de liberao Potncia relativa em duplicata albIFN residual Protena residual da clula hospedeira de levedura

Reverse Phase HPLC Purity Analysis of albIFN In-Process Samples Using the Jupiter C4 Column Reversed-Phase HPLC Sabouraud Agar Dextrose (SDA) Sample buffer Sample preparation Sample tube SCD broth SDS-Capillary Gel Electrophoresis (SDS-CGE) Second derivative UV Spectroscopy Semi-micro electrode semi-micro probe Shear stress Shutdown solution Silicon oil Silicone oil Silver stain Singlet Size Exclusion HPLC Analysis (SECHPLC) Slope sodium dodecyl sulfate (SDS) Soybean Casein Digest Agar (SCDA) Spike recovery Spiking Stainless steel exposure standard line equation standard operating procedure (SOP) stock solution Supernatant Supportive/Registration Stability Study System suitability testing test for parallelism Test sample Test sample tested spiked and unspiked Thermal Cycling tissue culture-treated 96-well flatbottom plates

Anlise da pureza das amostras de albIFN em processamento por HPLC de fase reversa utilizando a coluna Jpiter C4 HPLC de fase reversa Sabouraud Agar Dextrose (SDA) Tampo de amostra Preparao de amostra Tubo de amostra Fluido de SCD Eletroforese capilar em gel de SDS [dodecil sulfato de sdio] Espectroscopia UV derivada de segunda ordem Semi-microeletrodo Semi-microssonda Estresse de cisalhamento Soluo de interrupo leo de silicone leo de silicone Corante prata Singleto Anlise de HPLC de Excluso por Tamanho (SEC-HPLC) Declive dodecil sulfato de sdio (SDS) Meio Soybean Casein Digest Agar (SCDA) Recuperao por adio Adio Exposio a ao inoxidvel equao linear padro Procedimento operacional padro (SOP) soluo estoque Sobrenadante Estudo de Estabilidade de Suporte/de Registro Teste de adequao do sistema Teste de paralelismo Amostra de teste Amostra de teste Com e sem adio Ciclo Trmico placas de cultura de tecido de 96 poos com fundo chato

To average To be blanked Trending sample Tryptic peptide Tryptic Soy Agar (TSA) Turnable sample tray Vesicular stomatitis vrus (VSV) Wash buffer water blank injection Well y Intercept Yeast host cell protein (YHCP) Zoomed

Ponderar (calcular a mdia) Receber o branco Amostras tendenciosa Peptdeo trptico Meio Tryptic Soy Agar (TSA) bandeja giratria para amostras Vrus da Estomatite Vesicular (VSV) Tampo de lavagem injeo do branco de gua Poo Interceptao y Protena da clula hospedeira de levedura (YHCP) Ampliado(a)