CEVEC has developed a new and proprietary expression system for biopharmaceuticals based on human amniocytes offering significant advantages over existing production technologies.
Human cell-based expression systems are of special value for the expression and production of complex human therapeutic proteins, antibodies and related molecules, thus matching increasing demands for quality, identity and high expression rates. However, the number of human non-tumor derived cell types, which can be immortalized to stable high producer cells is very limited.
Amniocytes are derived from amniotic fluid cells obtained by amniocentesis. Amniocentesis is a clinical routine procedure performed during week 16 - 20 of gestation for prenatal diagnosis and ethically accepted and approved. CEVEC´s use of amniotic fluid volumes not required for clinical diagnosis is done in accordance with all legal and ethical requirements.
CEVEC´s intellectual property on amniocyte technology is protected worldwide within three patent families.
Using CEVEC's proprietary technology, primary human amniocytes have been immortalized by adenoviral genetic E1/pIX functions and selected for highly efficient CAP (CEVEC's Amniocyte Production) cell lines. CAP cell lines contain adenovirus type 5 nucleotide sequence 505-4079 including the E1 genes and the entire pIX sequence.
A master cell bank (MCB) of CAP cells growing in suspension has been established, tested and certified according to ICH guidelines and European Pharmacopeia. Therefore, a production cell line for your pharmaceutically active protein is just around the corner: Our simple and reliable protocols allow the fast generation of producer cell lines based on our parental permanent CAP cells under controlled and optimized conditions.
Requirements for the production of complex human proteins are:
- Safe agents with high specific activity
- Non-immunogenic profile
- Patient-friendly pharmacokinetics
- Produced in ethically accepted systems
The reality of existing biopharmaceutical production systems is:
- Lack of glycosylation (yeast, E.coli)
- Non-human carbohydrate residues that cause immune
- reactions (CHO, murine myeloma cells)
- Lack of authentic sialylation (human HEK293 cells)
- Failure to produce complex proteins in current expression systems
CAP cells offer the solution:
- Protein production with human posttranslational modifications
- Increase the specific activity, thereby reducing protein dose
- Avoid immunogenic non-human carbohydrate residues
- Include authentic sialylation for improved half-live
- High yields of authentic complex proteins thereby reducing costs of downstream processing
- Serum-free suspension culture
- One platform for both transient and stable expression