Single-use tangential flow filtration in bioprocessing: An approach to design and development

BioProcess International

Volumn 9, Issue 1, 2011, Pages 38-47

  Nicholson, Pauline ^a   Storm, Erik ^b  

^a Single Use Systems   (United Kingdom)

^b Pall Llife Sciences ^*  (United Kingdom)

Author keywords

Automation; Disposables; Filtration; Pat

Indexed keywords

AUTOMATION; BIOPROCESS; EXPERIMENTAL DESIGN; FILTRATION; MEMBRANE POTENTIAL; MICROTECHNOLOGY; SHORT SURVEY;

EID: 78651391832     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Short Survey

References (5)

1. Sterile Drugs Produced by Aseptic Processing - Current Good Manufacturing Practice (Guidance for Industry). US Food and Drug Administration, September 2004; www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070342.pdf.
2. PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Guidance for Industry). US Food and Drug Administration, September 2004; www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf
3. Botterill M, Rawlings B. Applying Good Engineering Practices to the Design of Single-Use Systems. BioProcess Int. 6(11) 2008: 18-25.
4. Fuller M, Pora H. Introducing Disposable Systems into Biomanufacturing: A CMO Case Study. BioProcess Int. 6(10) 2008: 30-36.
5. Warner TN, Nochumson S. Rethinking the Economics of Chromatography. Biopharm Int. January 2003: 58-60.