Formulation of a generic framework for integrated product and process development

2002 ◽  
Author(s):  
Pingtao Yan ◽  
Mengchu Zhou ◽  
D. Sebastian
Keyword(s):  
Process Development ◽  
Generic Framework ◽  
Product And Process

Design for Environment - Computer Based Product and Process Development

1997 ◽  
pp. 174-187 ◽  
Author(s):  
H. Schott ◽  
C. Grüner ◽  
K. Büttner ◽  
Wirtsch F. Dannheim ◽  
H. Birkhofer
Keyword(s):  
Process Development ◽  
Design For Environment ◽  
Computer Based ◽  
Product And Process

Short- and Medium-Term Product and Process Development

1996 ◽  
pp. 195-208
Author(s):  
Klaus G. Grunert ◽  
Hanne Hartvig Larsen ◽  
Tage Koed Madsen ◽  
Allan Baadsgaard
Keyword(s):  
Process Development ◽  
Medium Term ◽  
Product And Process

Systematic Product and Process Development Tools in Life Cycle Management

2020 ◽  
pp. 33-51
Author(s):  
Mohamad Taleuzzaman ◽  
Sanjay Chuhan ◽  
Sadaf Jamal Gilani ◽  
Syed Sarim Imam ◽  
Sarwar Beg
Keyword(s):  
Life Cycle ◽  
Process Development ◽  
Life Cycle Management ◽  
Development Tools ◽  
Product And Process

scholarly journals VectorMOD: Method for Bottom-Up Proteomic Characterization of rAAV Capsid Post-Translational Modifications and Vector Impurities

2021 ◽  
Vol 12 ◽  
Author(s):  
Neil G. Rumachik ◽  
Stacy A. Malaker ◽  
Nicole K. Paulk
Keyword(s):  
Mass Spectrometry ◽  
Process Development ◽  
Cell Protein ◽  
Macromolecular Complex ◽  
Bottom Up ◽  
Post Translational Modifications ◽  
Simple Step ◽  
Product And Process ◽  
High Doses ◽  
And Control

Progress in recombinant AAV gene therapy product and process development has advanced our understanding of the basic biology of this critical delivery vector. The discovery of rAAV capsid post-translational modifications (PTMs) has spurred interest in the field for detailed rAAV-specific methods for vector lot characterization by mass spectrometry given the unique challenges presented by this viral macromolecular complex. Recent concerns regarding immunogenic responses to systemically administered rAAV at high doses has highlighted the need for investigators to catalog and track potentially immunogenic vector lot components including capsid PTMs and PTMs on host cell protein impurities. Here we present a simple step-by-step guide for academic rAAV laboratories and Chemistry, Manufacturing and Control (CMC) groups in industry to perform an in-house or outsourced bottom-up mass spectrometry workflow to characterize capsid PTMs and process impurities.

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