Whether to build in-house manufacturing capacity or use external CDMO
Capital expenditure
Lack of expertise and worrying about the engineering work
Investment of MFG drain if the clinical trials don't go well
Challenges caused by future market uncertainties
Clear Background
EPIC-CHO® GS third-generation cell line is introduced from CHO K1 cell source and licensed for commercialization, domesticated and screened by BiBo's professional CLD R&D team, and obtained by using patented GS knockdown technology with high protein expression, etc. EPIC-CHO® GS has completed comprehensive testing of the cell line, and meets the filing requirements.
Mature Matching
Bibo has supporting expression vectors, media and culture processes to ensure stable production capacity from cell line development to commercial scale production and accelerate research and development progress.
Compliance with Regulatory Requirements
EPIC CHO® GS has completed comprehensive testing of cell lines and meets the requirements for biologics filing and marketing in China, the United States and Europe.
EPIC-CHO® GS has a complete package of solutions, including expression vector system (pBG series) with independent intellectual property rights, and high expression medium, which empowers customers to fast-track their projects from molecular sequence to commercial delivery.
EPIC-CHO® GS
EPIC-CHO®
pBG
pCG
EPIC-CHO® GS, with its reliable transfer stability (PDL=90), fully meets the requirements of BiBo's proprietary 30,000-liter scale-up in a single tank, empowering customers to commercialize their antibody and protein projects at a more competitive production cost and stable supply.
Available E. coli Expression System Components
Vector optimization: screening combinations of different signal peptide, promoter, dissolution enhancing tag, and purification tag, etc.
Host selection: BL21(DE3)、Rosetta-gami (DE3) pLysS 、BL21(DE3) pLysS, etc.
Accessory proteins: DsbA, Dnak, DnaJ, GroEL, GroES and more than 10 other proteins to the target protein secretion amount.
Available P.pastoris Expression System Components
Expression hosts: X33、GS115、KM71、SMD1168, etc.
Selection of promoters: inducible promoters PAOX (PAOX 1 and PAOX 2), constitutive promoter PGAP, etc.
Signal peptides: Several signal sequences are available, to ensure a precisely cleaved N-terminus of the product and high titer.
Copy number: single or multicopy
Accessory proteins: Hac1, Bip, Pdi, Ero1 and more than 10 kinds of auxiliary proteins, to enhance the target protein secretion amount.
| Procedure | Content |
|---|---|
| Plasmid construction | Plasmid profile |
| Strain screening | High throughput screening |
| Multi-copy strain screening | Antibiotic or Antibiotic free selection marker |
| High density fermentation | High throughput mini-bioreactor system |
