Applying quality by design to vaccine development - BioProcess ...
Applying quality by design to vaccine development - BioProcess ...
Applying quality by design to vaccine development - BioProcess ...
- No tags were found...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Key Changes <strong>to</strong> H1 DSP Between 2009 & 2010‣ H1 Process modifications were successfully evaluated at small‐scale in PD prior <strong>to</strong>transfer <strong>to</strong> manufacturingProcess step H1 2009 H1 2010 RationaleExtraction 0 mM NaCl 50 mM NaCl Improved yieldIEX –wash 2 0 mM NaCl 100 mM NaCl Increased purityIEX ‐ elution 100 mM NaCl 250 mM NaCl Increased step‐yieldHIC ‐ equilibration 0 % CHAPS 0.05% CHAPS Improved purityFrom Clone <strong>to</strong> Clinic®
Change language