FDA Inspection Success Avecia Biologics is delighted to announce that it successfully underwent its first Pre-Approval Inspection by the FDA in January 2009. The Inspection, which was in relation to a client's Biologics Licence Application, resulted in just one 483 observation. The FDA Inspection was closely followed by an Inspection from the UK Medicines & Healthcare products Regulatory Agency (MHRA). This was in support of Avecia's application for a manufacturing licence for 'commercial product'. It too made just one observation, classed as 'other'.

"The Avecia Toolbox"   Insoluble protein expression? How to ensure success at scale Short fermentation times and high expression levels make E. coli an attractive host for low cost protein production. Unfortunately many useful therapeutic proteins express as insoluble and inactive inclusion bodies in E. coli and require in vitro refolding to make the active product. At Avecia we are experts in developing high yielding refolding processes that can be readily scaled up. One key thing that customers can do to improve the chances of success is the development of robust and high throughput methods so that conditions that promote refolding can be easily spotted. We have extensive experience in the development, scale-up and operation of many processes, but no-one knows your protein as well as you do. To answer your personal scales up issues please contact us at biotech@avecia.com. Reductant alternatives to a smelly situation When your protein needs reducing, having you considered switching from ß-mercaptoethanol or DTT to TCEP? This reagent is very effective and in fact usually preferred to the others for scale-up as the half-life and stability at a range of pHs is far superior. Remember, that which may take a few minutes at lab scale can take a lot longer during manufacture. As an added bonus, your lab will smell a whole lot sweeter!

Win tickets for the Atlanta Braves! Will you be at BIO 2009 in Atlanta? Enter our prize draw to win tickets for you and a colleague to visit Turner Field on Tuesday May 19th for the Braves vs Rockies. Click here to enter your name and contact details. The draw will take place on Friday May 1st. Avecia will be at BIO 2009 on Booth 5325 and look forward to seeing you there!