BBI Solutions - the Antibody experts
Let our knowledgeable team of antibody experts fulfil your manufacturing needs in our ISO certified, cGMP facility. Whether you require 100mg of antibody for research purposes or 3 grams for your in vitro diagnostic assay, we have a flexible service to meet your needs.
In vitro antibody manufacture
We offer in vitro cell culture manufacture of monoclonal antibody in roller bottle and hollow fibre systems. Our ISO certified, cGMP* facility can accommodate the single-batch manufacture of tens of milligrams up to 5-gram quantities of antibody.
10 mg to 1 gram In vitro monoclonal antibody manufacture via roller bottle
Media formulations containing low bIgG fetal bovine serum, serum-free media, or animal component-free media can be used for productions when more stringent requirements are necessary. Productions are designed to limit the introduction of endotoxin.
- All incoming cell lines require BBI mycoplasma testing
- Cultures are grown in custom media and harvested for optimal antibody yield
- R&D and bulk production volumes are available
- cGMP production report is provided
- Monoclonal antibody containing supernatant is typically concentrated and purified prior to shipment
We also offer custom cell culture production of other mammalian cell lines (CHO, HEK 293) in addition to our standard hybridoma service offerings.
BBI offers scalable production models to fit your needs
In vitro antibody production in hollow fibre
For customers who require larger than 1 gram lot sizes and predictable yields, BBI now offers cGMP* in vitro antibody productions in a hollow fibre continuous perfusion system, significantly improving scalability and security in bulk.
Why hollow fibre production with BBI?
+ Batch sizes up to 5 grams
+ Serum and animal component-free culture system • No contaminating mouse or bovine IgG
+ Predictable long-term costs and ability for guaranteed yields
+ Extensive expertise and capabilities in the maintenance of hybridoma cell lines, including routine subcloning
+ Protein A purification for highly pure monomeric antibody
+ Option to conjugate bulk productions to BBI’s gold nanoparticles, or seamlessly integrate with our lateral flow services
There are 3 production models to fit your requirements:
+ Evaluate productivity of cell line in hollow fibre via 4-week production run
+ 200-400mgs of cGMP* antibody
+ Post pilot, cell lines are eligible for fixed cost model
Fixed Cost Model:
+ Generate defined mass of purified monoclonal antibody
+ Defined monoclonal antibody quantity delivered at a fixed per/mg price
Run Time Model:
+ If defined yield or fixed pricing is not required, run a production for a defined number of weeks in a time billing model
+ All purified antibody generated in the time scale is delivered at the close of production run
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*21 CFR Part 820, For research and In Vitro diagnostic use only