Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: Towards a global multi‐step design space

Journal of Pharmaceutical Sciences ◽

10.1002/jps.23273 ◽

2012 ◽

Vol 101 (10) ◽

pp. 3604-3618 ◽

Author(s):

Alex Eon-Duval ◽

Pascal Valax ◽

Thomas Solacroup ◽

Hervé Broly ◽

Ralf Gleixner ◽

...

Keyword(s):

Fusion Protein ◽

Manufacturing Process ◽

Quality By Design ◽

Design Space ◽

Drug Substance ◽

Design Approach ◽

Fc Fusion Protein ◽

Quality By Design Approach

Download Full-text

Quality by design approach of a pharmaceutical gel manufacturing process, part 1: Determination of the design space

Journal of Pharmaceutical Sciences ◽

10.1002/jps.22611 ◽

2011 ◽

Vol 100 (10) ◽

pp. 4432-4441 ◽

Author(s):

Juan G. Rosas ◽

Marcel Blanco ◽

Josep M. González ◽

Manel Alcalá

Keyword(s):

Manufacturing Process ◽

Quality By Design ◽

Design Space ◽

Design Approach ◽

Quality By Design Approach

Download Full-text

Quality by Design approach in the development of a magnetic transducer for biomedical measurements: preliminary results on Design Space configuration

Journal of Physics Conference Series ◽

10.1088/1742-6596/772/1/012016 ◽

2016 ◽

Vol 772 ◽

pp. 012016 ◽

Author(s):

D R Louzada ◽

E C Monteiro ◽

A M Rivero ◽

L G S Fortaleza ◽

C R H Barbosa ◽

...

Keyword(s):

Quality By Design ◽

Design Space ◽

Design Approach ◽

Preliminary Results ◽

Magnetic Transducer ◽

Quality By Design Approach ◽

Biomedical Measurements

Download Full-text

Application of a Quality by Design Approach to the Cell Culture Process of Monoclonal Antibody Production, Resulting in the Establishment of a Design Space

Journal of Pharmaceutical Sciences ◽

10.1002/jps.23744 ◽

2013 ◽

Vol 102 (12) ◽

pp. 4274-4283 ◽

Author(s):

Hiroaki Nagashima ◽

Akiko Watari ◽

Yasuharu Shinoda ◽

Hiroshi Okamoto ◽

Shinya Takuma

Keyword(s):

Cell Culture ◽

Monoclonal Antibody ◽

Antibody Production ◽

Quality By Design ◽

Design Space ◽

Design Approach ◽

Cell Culture Process ◽

Monoclonal Antibody Production ◽

Culture Process ◽

Quality By Design Approach

Download Full-text

Optimization of the manufacturing process of a complex amphotericin B liposomal formulation using quality by design approach

International Journal of Pharmaceutics ◽

10.1016/j.ijpharm.2020.119473 ◽

2020 ◽

Vol 585 ◽

pp. 119473

Author(s):

Huolong Liu ◽

Benjamin Rivnay ◽

Ken Avery ◽

Ja Hye Myung ◽

Darby Kozak ◽

...

Keyword(s):

Amphotericin B ◽

Manufacturing Process ◽

Quality By Design ◽

Design Approach ◽

Liposomal Formulation ◽

Quality By Design Approach

Download Full-text

Quality by design approach of a pharmaceutical gel manufacturing process, part 2: Near infrared monitoring of composition and physical parameters

Journal of Pharmaceutical Sciences ◽

10.1002/jps.22607 ◽

2011 ◽

Vol 100 (10) ◽

pp. 4442-4451 ◽

Author(s):

Juan G. Rosas ◽

Marcel Blanco ◽

Josep M. González ◽

Manel Alcalá

Keyword(s):

Manufacturing Process ◽

Quality By Design ◽

Near Infrared ◽

Design Approach ◽

Physical Parameters ◽

Quality By Design Approach ◽

Infrared Monitoring

Download Full-text

Quality-by-Design approach to monitor the operation of a batch bioreactor in an industrial avian vaccine manufacturing process

Journal of Biotechnology ◽

10.1016/j.jbiotec.2015.07.001 ◽

2015 ◽

Vol 211 ◽

pp. 87-96 ◽

Author(s):

Martina Largoni ◽

Pierantonio Facco ◽

Donatella Bernini ◽

Fabrizio Bezzo ◽

Massimiliano Barolo

Keyword(s):

Manufacturing Process ◽

Quality By Design ◽

Design Approach ◽

Batch Bioreactor ◽

Quality By Design Approach

Download Full-text

Application of the Quality by Design Approach to the Freezing Step of Freeze-Drying: Building the Design Space

Journal of Pharmaceutical Sciences ◽

10.1016/j.xphs.2018.02.003 ◽

2018 ◽

Vol 107 (6) ◽

pp. 1586-1596 ◽

Author(s):

Andrea Arsiccio ◽

Roberto Pisano

Keyword(s):

Freeze Drying ◽

Quality By Design ◽

Design Space ◽

Design Approach ◽

Quality By Design Approach

Download Full-text

Quality by Design approach in the development of a solvent-modified micellar electrokinetic chromatography method: Finding the design space for the determination of amitriptyline and its impurities

Analytica Chimica Acta ◽

10.1016/j.aca.2013.10.005 ◽

2013 ◽

Vol 802 ◽

pp. 113-124 ◽

Author(s):

S. Furlanetto ◽

S. Orlandini ◽

B. Pasquini ◽

M. Del Bubba ◽

S. Pinzauti

Keyword(s):

Quality By Design ◽

Micellar Electrokinetic Chromatography ◽

Design Space ◽

Design Approach ◽

Electrokinetic Chromatography ◽

Chromatography Method ◽

Quality By Design Approach

Download Full-text

Implementation of quality by design approach in manufacturing process optimization of dry granulated, immediate release, coated tablets – a case study

Drug Development and Industrial Pharmacy ◽

10.1080/03639045.2017.1328431 ◽

2017 ◽

Vol 43 (10) ◽

pp. 1626-1636 ◽

Author(s):

Michał Teżyk ◽

Emilia Jakubowska ◽

Bartłomiej Milanowski ◽

Janina Lulek

Keyword(s):

Process Optimization ◽

Manufacturing Process ◽

Quality By Design ◽

Immediate Release ◽

Design Approach ◽

Quality By Design Approach

Download Full-text

Preparation and Optimization of Moxifloxacin Microspheres for Colon Targeted Delivery Using Quality by Design Approach: In Vitro and In Vivo Study

Current Drug Delivery ◽

10.2174/1567201813666160512145625 ◽

2016 ◽

Vol 13 (7) ◽

pp. 1021-1033 ◽

Author(s):

Bhumika Prajapati ◽

Prasant Kumar Jena ◽

Tejal Mehta ◽

Sriram Seshadri

Keyword(s):

Targeted Delivery ◽

Quality By Design ◽

Design Approach ◽

In Vivo Study ◽

Quality By Design Approach

Download Full-text