about
Industrialization of mAb production technology: the bioprocessing industry at a crossroadsClinical manufacturing of CAR T cells: foundation of a promising therapyThe Future of Pharmaceutical Manufacturing SciencesEarly implementation of QbD in biopharmaceutical development: a practical exampleImplementing quality by design for biotech products: Are regulators on track?Glycotherapy: new advances inspire a reemergence of glycans in medicineAptamers as a sensitive tool to detect subtle modifications in therapeutic proteinsExploiting virus-like particles as innovative vaccines against emerging viral infectionsPepsin-Containing Membranes for Controlled Monoclonal Antibody Digestion Prior to Mass Spectrometry Analysis.Bioprocess development workflow: Transferable physiological knowledge instead of technological correlations.Exploring the linkage between cell culture process parameters and downstream processing utilizing a plackett-burman design for a model monoclonal antibody.Uncertainty estimates of purity measurements based on current information: toward a "live validation" of purity methodsModel-based analysis on the extractability of information from data in dynamic fed-batch experiments.Role of Knowledge Management in Development and Lifecycle Management of BiopharmaceuticalsHuman pluripotent stem cell differentiation to functional pancreatic cells for diabetes therapies: Innovations, challenges and future directions.Evaluation of protein engineering and process optimization approaches to enhance antibody drug manufacturability.Discerning key parameters influencing high productivity and quality through recognition of patterns in process data.N-terminal glutamate to pyroglutamate conversion in vivo for human IgG2 antibodiesTowards controlling the glycoform: a model framework linking extracellular metabolites to antibody glycosylationApproach to design space from retrospective quality data.Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy.The criticality of high-resolution N-linked carbohydrate assays and detailed characterization of antibody effector function in the context of biosimilar development.Detection of Infertility-related Neutralizing Antibodies with a Cell-free Microfluidic Method.Applications of Raman Spectroscopy in Biopharmaceutical Manufacturing: A Short Review.Quality assessment for clinical proteomics.Differential response in downstream processing of CHO cells grown under mild hypothermic conditions.Developability studies before initiation of process development: improving manufacturability of monoclonal antibodies.Case study and application of process analytical technology (PAT) towards bioprocessing: Use of tryptophan fluorescence as at-line tool for making pooling decisions for process chromatography.A review of advanced small-scale parallel bioreactor technology for accelerated process development: current state and future need.Chemometrics applications in biotech processes: a review.Aggregates in monoclonal antibody manufacturing processes.Recent developments in membrane-based separations in biotechnology processes: review.Review of computational fluid dynamics applications in biotechnology processes.Quality attributes of recombinant therapeutic proteins: an assessment of impact on safety and efficacy as part of a quality by design development approach.Minimizing immunogenicity of biopharmaceuticals by controlling critical quality attributes of proteins.Understanding pharmaceutical quality by designTools for monitoring system suitability in LC MS/MS centric proteomic experiments.Application of quality by design and statistical quality control concepts in immunoassays.Next generation vaccines and vectors: Designing downstream processes for recombinant protein-based virus-like particles.Fluorescence spectroscopy and chemometric modeling for bioprocess monitoring.
P2860
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P2860
description
2009 nî lūn-bûn
@nan
2009 թուականի Յունուարին հրատարակուած գիտական յօդուած
@hyw
2009 թվականի հունվարին հրատարակված գիտական հոդված
@hy
2009年の論文
@ja
2009年論文
@yue
2009年論文
@zh-hant
2009年論文
@zh-hk
2009年論文
@zh-mo
2009年論文
@zh-tw
2009年论文
@wuu
name
Quality by design for biopharmaceuticals.
@ast
Quality by design for biopharmaceuticals.
@en
Quality by design for biopharmaceuticals.
@nl
type
label
Quality by design for biopharmaceuticals.
@ast
Quality by design for biopharmaceuticals.
@en
Quality by design for biopharmaceuticals.
@nl
prefLabel
Quality by design for biopharmaceuticals.
@ast
Quality by design for biopharmaceuticals.
@en
Quality by design for biopharmaceuticals.
@nl
P356
P1433
P1476
Quality by design for biopharmaceuticals.
@en
P2093
Anurag S Rathore
Helen Winkle
P2888
P356
10.1038/NBT0109-26
P577
2009-01-01T00:00:00Z