[go: up one dir, main page]

Undey et al., 2011 - Google Patents

Pat applied in biopharmaceutical process development and manufacturing: an enabling tool for quality-by-design

Undey et al., 2011

Document ID
742412860332618370
Author
Undey C
Low D
Menezes J
Koch M
Publication year

External Links

Snippet

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for …
Continue reading at books.google.com (other versions)

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/26Conditioning of the fluid carrier; Flow patterns
    • G01N30/38Flow patterns
    • G01N30/46Flow patterns using more than one column
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by the preceding groups
    • G01N33/48Investigating or analysing materials by specific methods not covered by the preceding groups biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using infra-red, visible or ultra-violet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40Concentrating samples
    • G01N1/4077Concentrating samples by other techniques involving separation of suspended solids

Similar Documents

Publication Publication Date Title
Maruthamuthu et al. Process analytical technologies and data analytics for the manufacture of monoclonal antibodies
Wasalathanthri et al. Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review
Kumar et al. Why is batch processing still dominating the biologics landscape? Towards an integrated continuous bioprocessing alternative
Silva et al. Automation and miniaturization: enabling tools for fast, high‐throughput process development in integrated continuous biomanufacturing
Chen et al. Digital twins in pharmaceutical and biopharmaceutical manufacturing: a literature review
Fisher et al. The current scientific and regulatory landscape in advancing integrated continuous biopharmaceutical manufacturing
Zobel-Roos et al. Accelerating biologics manufacturing by modeling or: is approval under the QbD and PAT approaches demanded by authorities acceptable without a digital-twin?
Reyes et al. Modern sensor tools and techniques for monitoring, controlling, and improving cell culture processes
Randek et al. On-line soft sensing in upstream bioprocessing
Wang et al. Development of novel bioreactor control systems based on smart sensors and actuators
Mehdizadeh et al. Generic R aman‐based calibration models enabling real‐time monitoring of cell culture bioreactors
Goldrick et al. High-throughput Raman spectroscopy combined with innovate data analysis workflow to enhance biopharmaceutical process development
Ündey et al. Applied advanced process analytics in biopharmaceutical manufacturing: Challenges and prospects in real-time monitoring and control
Helgers et al. Towards autonomous operation by advanced process control—process analytical technology for continuous biologics antibody manufacturing
Matte Recent advances and future directions in downstream processing of therapeutic antibodies
Rathore et al. Chemometrics applications in biotech processes: a review
Carrondo et al. How can measurement, monitoring, modeling and control advance cell culture in industrial biotechnology?
Łącki High throughput process development in biomanufacturing
Van der Borght et al. Information-driven catalyst design based on high-throughput intrinsic kinetics
Undey et al. Pat applied in biopharmaceutical process development and manufacturing: an enabling tool for quality-by-design
Drobnjakovic et al. Current challenges and recent advances on the path towards continuous biomanufacturing
Schmidt et al. Fast and flexible mrna vaccine manufacturing as a solution to pandemic situations by adopting chemical engineering good practice—continuous autonomous operation in stainless steel equipment concepts
Albino et al. Hybrid modeling for on-line fermentation optimization and scale-up: a review
Jenzsch et al. Trends in process analytical technology: Present state in bioprocessing
Huter et al. Model validation and process design of continuous single pass tangential flow filtration focusing on continuous bioprocessing for high protein concentrations