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cGMP Manufacturing at 1000L scale

Articles & Presentations

March 2012

Achieving Optimal Performance from Single Use Systems.

Webinar : Achieving Optimal Performance from Single Use Systems. Stewart McNaull, Section Leader, Upstream Process Development, from our RTP, North Carolina Office, and Bo Kara, Director of Science & Technology from our Billingham, UK site, delivered this webinar organised by Xtalks. During the webinar they discussed how we have provided manufacturing flexibility under accelerated timelines on a cost-effective basis, and how we compared process and product quality data for single-use systems vs stainless steel reactors, critical factors to consider when selected the elements of the final (1000L) manufacturing train.

Click here to view the archive on Xtalks website.

December 2012

Lean Six Sigma : A CMO's Most Useful Travelling Companion

Read Stephen Taylor's article in BioProcess International's December Supplement


July 2012

Optimizing Expression Systems

Jonathan Pointon, PhD, principal scientist, describes in this article in the July issue of BioPharm International how Fujifilm Diosynth Biotechnologies' pAVEway(TM) expression system can help ensure high product titers and efficient scale-up to GMP manufacture, while minimizing issues such as leaky expression, that can have detrimental effects on host and plasmid stability. For link to the article click here.


January 2013

Site Specific PEGylation at Histidine Tags

John Liddell, Ian Hodgson and Charles Heise at Fujifilm Diosynth Biotechnologies, Billingham, UK, are co-authors of this paper, in conjuntion with PolyTherics Limited, and UCL School of Pharmacy. The article, which describes the covalent conjustation of PEG site-specifically to a polyhistidine tag (His-tag) on a protein, can be viewed online on Bioconjugate Chemistry here or you can download a copy here.


October 2013

'Drawn to Scale'

Graham McCreath, Head of Process Design and Mahesh Shivhare, Senior Process Statistician at Fujifilm Diosynth Biotechnologies, Billingham, UK, discuss how small scale process modelling can be used in simulation studies to help predict the performance of a commercial biopharmaceutical process.

This article appears in the October Edition of European Biopharmaceutical Review and can be viewed online here or you can download the article here


May 31st 2013

George Koch, Chief Scientific Officer for Contract Manufacturing and Director of Project Manager for Fujifilm Diosynth Biotechnologies, RTP, NC presents a BPI Webinar "Key Aspects of Managing Early Phase Development Programs for Long Term Success"


May 2013

'The Perfect Host'
John Liddell, Head of Process & Analytical Sciences and Ian Hodgson, Head of Molecular Biology at Fujifilm Diosynth Biotechnologies, Billingham, UK, discuss how microbial hosts can be used to express a range of antibodies and antibody fragments.

This article appears in the Spring Edition of European Biopharmaceutical Review and can be viewed by subscribing here

Or you can download the article here.



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