The customers of e-Proteins are active in the life science domain, including pharmaceuticals and diagnostics; the certifications offered by e-Proteins concern essentially its avidin production system. e-Proteins always aims to offer the best quality in regards to ‘’product’’ rather than just the documentary system.
Avidin Certification ISO-9001 : 2015
The functioning quality system (ISO-9001:2015) is regularly audited by independent organizations. The system ISO9001 of e-Proteins for the production of avidin destined for biotechnological and pharmaceutical sectors is certified by ‘ww.sgs.com’. This is the guarantee that the activities of e-Proteins take place in conformity with all regulations which are applied to the sectors for which it is intended.
All of the usage precautions are taken to protect and back up the document data and I.T. linked to the traceability of our production.
GMP avidin Certification
This certification is available for companies proceeding clinical Trials with an EUDRA number or IND Code. This certification is validated by the Belgian National health Agency according to the use of the supplied drug substance to the customer . As all procedure are in place and in use, this certification takes about 3 months depending on the requested avidin quality and certifications (6 months more with virus inactivation steps , see below).
For the GMP avidin certification, e-Proteins applies the following guidelines
- Guideline on virus safety evaluation of biotechnological investigational medicinal
- Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products (EMA/CHMP/BWP/814397/2011)
- Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products (EMA/CHMP/BWP/429241/2013)
Note for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses (CPMP/BWP/268/95)
All batch records are analysed online using a comprehensive set of control systems. Any deviation is analysed and immediately corrected, and documented in a deviation report.
As the avidin is an animal origin product , e-Proteins is audited by the National Veteran agency every years in ordre to confirm its approval .
Virus inactivation and Virus removal step for avidin
e-Proteins has investigated more than 7 different methods for the Virus inactivation / removal . Only 3 of them enable to keep the maximum product activity. Depending on the customers requirements for its drug substance , e-Proteins can apply at least 2 of those methods in order to obtain the Virus inactivation/removal certification by a certified viral safety company. This certification takes about 9 months.
Avidin Certification sterile
To achieve a sterile certification with a certificate, e-Proteins subcontracts this step to a company with the appropriate equipment and infrastructure specialized in this field. Certified sterile avidin may then be released by the skilled e-Proteins pharmacist as a Drug Product, namely a product that can be used in an injectable way in clinical trials.