Cell Therapy & Gene Therapy — Application Guides
Three expert guides for ATMP and gene therapy manufacturing workflows — from iPSC and hPSC maintenance to AAV viral vector production in HEK293T and monoclonal antibody production via hybridoma technology.
Cell and gene therapy manufacturing places the highest demands on biological raw material quality. A single lot change in FBS can shift viral vector yields by 10-fold, alter iPSC differentiation efficiency, or co-purify bovine IgG with your therapeutic mAb. These guides cover the serum selection, lot testing, and bioprocessing decisions that determine manufacturing success — from research scale to clinical GMP.
AAV Viral Vector Production — HEK293T & FBS Guide
How FBS endotoxin reduces AAV yield, lot testing protocol, when to switch to serum-free, and single-use bioprocessing for rAAV scale-up.
Anleitung lesen →iPSC & Stem Cell Culture — Feeder-Free Medium & Serum Guide
When iPSC culture uses FBS, when it's serum-free, HiDef-B8 as mTeSR alternative, and differentiation serum strategy by lineage.
Anleitung lesen →Hybridoma & mAb Production — FBS & Serum Guide
Three-phase serum strategy for hybridoma fusion, cloning and mAb production — Low IgG and Ultra Low IgG FBS for Protein A/G purification.
Anleitung lesen →Recommended Products for Cell & Gene Therapy
Key Regulatory Considerations
Cell and gene therapy products fall under ATMP (Advanced Therapy Medicinal Product) regulation in the EU and BLA/IND frameworks in the US. FBS used in manufacturing requires full traceability documentation — including country of origin, TSE/BSE statement, endotoxin and sterility testing, and viral safety panel. SeamlessBio provides complete regulatory documentation packages for GLP and pre-GMP applications:
- Certificate of Analysis (sterility, mycoplasma, endotoxin, haemoglobin, viral panel)
- TSE/BSE Statement and country-of-origin certificate
- USDA import permit (for US regulatory submissions)
- Batch reservation documentation for multi-lot bridging studies
- BVDV RNA/qPCR testing (additional service, separately documented)
Regulatory-Grade FBS for ATMP Manufacturing
Request a documentation package, lot reservation quote, or FBS Low Endotoxin sample for your AAV, iPSC or mAb manufacturing workflow.
E-Mail: info@seamlessbio.de | +49 851 37932226 | seamlessbio.de/contact
English 
Deutsch