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cGMP Manufacturing at 1000L scale

Articles & Presentations

October 2014

Read an article in October issue of European Biopharmaceutical Review by Dr Alison Porter, Head of Mammalian Cell Culture R&D at FUJIFILM Diosynth Biotechnologies' UK site. In the article Alison explains what must be considered when creating a new host cell line, and gives tips on how to save future development time and meet production requirements.

To read the full article click here: http://www.samedanltd.com/magazine/12/issue/223/article/3921 or you can download the article here.

May 2014

Please see below two posters presented at Cell Culture Engineering XIV in Quebec in May:

1) Using a direction evolution approach to identify CHO host cell lines with improved characteristics. Authors - Fay Saunders, Nazanin Dadehbeigi, Leon Pybus, Alison Porter. Mammalian Cell Culture R&D, FUJIFILM Diosynth Biotechnologies, UK

2) Optimization and control of monoclonal antibody product quality using a media and process toobox approach Authors : Min Zhang, Megan McCann, Stewart McNaull, Tim Hill. Upstream Process Development, FUJIFILM Diosynth Biotechnologies, USA.


February 2014

ADCs are showing great promise as a new therapeutic entity, but have a complex supply chain requiring biologics and high potency capability. This presentation from FUJIFILM Diosynth and our alliance partners Piramal Healthcare demonstrates our integrated approach for rapid delivery of ADCs

Click here to listen to our webinar hosted by InPharmaTechnologist entitled "A One Stop Shop Solution for the Manufacture of ADCs"


February 2014

Dr Alison Porter, our Head of Mammalian Cell Culture R&D, contributed to Genetic Engineering News' article "Cell Line Development: Where Nature Meets Nurture" in their February 1 2014 issue:

Click here to view online.


March 2013

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.


March 2013

Human hair follicle dermal sheath and papilla cells support keratinocyte growth in monolayer coculture

Rebecca Hill (Staff Scientist), Rachel Richer (Principal Scientist) and Anna Dodds (Staff Scientist) at FUJIFILM Diosynth Biotechnologies, are co-authors of this paper, published on Wiley's On-line library@

Read Paper


December 2012

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

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


November 2012

Generation and Characterization of Multipotent Stem Cells from Established Dermal Cultures

Rebecca Hill (Staff Scientist) and Bo Kara (Director of Science & Technology) at FUJIFILM Diosynth Biotechnologies, are co-authors of this paper, published on PLOS ONE. Read Article


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 2012

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 2011

'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 2011

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 2011

'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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