Process analytical technology (PAT) tools for the cultivation step in biopharmaceutical production

The process analytical technology (PAT) initiative is now 10 years old. This has resulted in the development of many tools and software packages dedicated to PAT application on pharmaceutical processes. However, most applications are restricted to small molecule drugs, mainly for the relatively simple process steps like drying or tableting where only a limited number of parameters need to be controlled. A big challenge for PAT still lies in applications for biopharmaceuticals and then especially in the cultivation process step, where the quality of a biopharmaceutical product is largely determined. This review gives an overview of the currently available tools for monitoring and controlling the biopharmaceutical cultivation step and of the main challenges for the most common cell platforms (i.e. Escherichia coli, yeast, and mammalian cells) used in biopharmaceutical manufacturing. The real challenge is to understand how intracellular mechanisms (from synthesis to excretion) influence the quality of biopharmaceuticals and how these mechanisms can be monitored and controlled to yield the desired end product quality. Modern “omics” tools and advanced process analyzers have opened up the way for PAT applications for the biopharmaceutical cultivation process step

Additional investigation into the sero-response on immunisation of volumnteers with group A and C meningococcal vaccine

Uit de in dit aanvullende onderzoek verkregen gegevens werd geconcludeerd: 1. De ELISA van antistoffen gericht tegen groep A en groep C kapselpolysacchariden geeft resultaten die in bevredigende mate zijn gecorreleerd met die van de bactericidie-proef. 2. De immuunrespons, gemeten 14 dagen na vaccinatie voldoet aan de internationale WHO eis met betrekking tot de stijging van de antistofgehalten en aan die m.b.t. het percentage personen (max. 10%) dat geen of een te geringe stijging vertoont. De bereikte antistoftiters bereiken bij 90% (A), resp. (93%) (C) van de vrijwilliger dat als beschermend wordt beschouwd (2 ug/ml of hoger). 3. Er kunnen geen significante verschillen tussen de 3 onderzochte partijen A+C polysaccharide vaccin worden vastgesteld. Gezien deze conclusies lijken er geen belemmeringen te bestaan dit vaccin voor immunisatie van mensen te gebruiken.Abstract not availableRIV