by Trefor Jones` | Sep 20, 2017 | Industry News
This is the second of a series of articles I am writing looking at the technology transfer and industrialisation / commercialisation of gene and cell therapy products. In this part I will give an overview of some of the pitfalls that befall companies looking to...
by Trefor Jones` | Aug 20, 2017 | Industry News
Download PDF: WC500219500 On Dec 15th. 2016 the EMA published a draft set of Q&A on the setting and use of Health Based Exposure Levels (HBEL). However in this document they stated that “it is not intended to be used to set cleaning limits at the level of the...
by Trefor Jones` | Aug 18, 2017 | Industry News
Download as PDF:MOC coupons unavailable for Cleaning Validation What to do if you can’t use or obtain samples of materials used in your manufacturing process for cleaning validation recovery studies. Regulatory Expectations It is a regulatory expectation (e.g....
by Trefor Jones` | Aug 7, 2017 | Industry News
Considerations for the technology transfer of Cell Therapy products. Part 1 Download as pdf This is the first of a series of articles I am writing looking at the technology transfer and industrialisation of gene and cell therapy products. In this part I will give an...
by Trefor Jones` | Jul 10, 2017 | Industry News
Download: 7Questions you should ask before starting technology transfer 1 – Can your process be manufactured according to the concepts of cGMP? According to the FDA: CGMP refers to the Current Good Manufacturing Practice regulations. CGMPs assure proper design,...
by BlueHatch Consultancy | Jul 1, 2017 | Industry News
Article by Trefor Jones The failure of a Technology Transfer process will, at best result in delays to product sales and increased costs, and at worst may lead to 483 notices, warning letters, loss of reputation and most importantly an impact on the health of...
