Regulatory
Producing biopharmaceuticals means following the highest quality and regulatory standards defined by national and international authorities like the Food and Drug Administration (FDA) or the European Medicines Agency (EMEA). Working under cGMP or GLP, an immense number of directives (e.g., European Pharmacopoeia (EP) or ICH guidelines) has to be followed strictly, including qualification of equipment, validation of methods and full documentation of supplies and procedures
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Bringing biopharmaceuticals through clinical trials and finally to the market, implies thorough establishment of the producing cell line under the most recent and stringent quality standards.
The development of CEVEC´s CAP cells has been fully documented and master cell banks (MCBs) of suspension CAP cells have been certified according to GMP/GLP principles and ICH guidelines.
The cell donor is fully documented including informed consent and all materials and process steps are fully documented according to standard operating procedures (SOPs).
The MCB is certified as follows:
- Isoenzyme analysis using four enzymes
- Transmission Electron microscopy (TEM)
- In vitro assay for the presence of bovine viruses
- Reverse transcriptase assay using F-Pert assay
- In vitro assay for the presence of viral contamination, 28 days using 2 cell lines (Vero and MRC5)
- In vivo assay for the presence of viral contamination using embryonated eggs
- Sterility according to EP including validation for the first test item using direct inoculation
- Mycoplasma according to EP/USP culture method and indicator cell assay including interference test
- PCR assay for the presence of the following human viruses: Epstein-Barr Virus (EBV), Herpes Simplex Virus (HSV) 1 and 2, Human Herpesvirus (HHV) 6, 7 and 8, Human Immundeficiency Virus (HIV) 1 and 2, human Papillomavirus (HPV), Parvovirus B19, Hepatitis A, B and C Virus, Influenza A and B Virus
