The Company has a strong expertise through the entire manufacturing process

Based on the genes provided by its customers, BioProtein Technologies generates transgenic rabbit lines. These animals are ideal bioreactors for producing gram to kilogram quantities of complex glycosylated proteins and vaccines within a framework that is fast, safe, and less expensive than other bioreactors.
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BioProtein Technologies owns the relevant intellectual property and has developed the know-how that allows its researchers to quickly generate transgenic rabbits expressing defined proteins in their milk. In particular, four patent families protect the entire production process. These include the exclusive worldwide rights for the use of the rabbit WAP (Whey Acidic Protein) gene promoter, a key promoter for secreting proteins or VLP-based vaccines in milk.
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:::::::: Your Integrated Manufacturing Solution

From your selected gene or cDNA encoding a given protein, BioProtein Technologies generates transgenic rabbit lines that express the biopharmaceutical in their milk. From this milk, the Company will extract and purify the protein or VLP-based vaccine of interest in a GMP environment and will deliver kilogram quantities of highly purified proteins both time- and cost-effectively.

Typically, 20 founder rabbits are generated in the standard process. Indeed, the low cost of rabbit embryos and the ability to transfer up to 20 embryos per recipient females allow the Company to generate a large number of transgenic founders for each project. This gives the opportunity to increase the chances to obtain one or several transgenic rabbit lines expressing sifficient quantities of biologically active proteins.

Founders will be selected for their efficiency to produce the protein of interest in their milk and used to generate a second and large generation (F1) of transgenic rabbits. Transgenic F1 progeny is identified via tissue biopsy followed by a PCR analysis. Sexually mature transgenic F1 females are then inseminated with non-transgenic sperm. Their milk is mechanically collected and the recombinant protein is characterized in order to select the best offspring lines for large scale production and to develop the purification process strategy (GLP, pre-GMP, GMP). In parallel, sperm from a well characterized F1 transgenic males is collected and cryopreserved in liquid nitrogen -Master Sperm Bank, MSB-, as recommended by the FDA Guidelines and the European Regulation. This sperm will be used to artificially inseminate non-transgenic females to generate the second filial offspring (F2).

Sperm from F2 transgenic males -Working Sperm Bank, WSB- is recovered and will serve, for 15 to 20 years, at generating transgenic F3 females which will produce industrial amounts of recombinant proteins or vaccine in their milk.

As a rabbit can have 8-10 litters each year with an average of seven young rabbits, the production scale-up can be quickly reached from an original group of founders.

The Company will manage both protein isolation and purification process (GMP), returning recombinant protein to customer. A partnership with Eurogentec, a Belgian company specialized and validated for protein purification under GMP requirements, has been developed to that issue. -->More...