Technology
Transgenic Production Technology Platform (TPTP): Baxalta Pharmaceutical Company’s patented technology platform is the solid foundation upon which the company has been built.
Our unique, highly scalable reproducible production methodology is a GMP validated process for the production of high quality recombinant human proteins. The economical process is supported by clinical proven safety and efficacy data, which demonstrate lower immunogenicity compared with current cell-line or plasma fractionation-based methods.
The advent of recombinant DNA technology opened the door for significant medical advances. Recognizing the opportunity to create life-changing therapies for rare medical conditions and the large unmet medical needs, we focused on the generation of transgenic animals which express human recombinant proteins only in their milk. This enables the safe, pure production of a protein.
Through our proprietary transgenesis method, we are able to make complex therapeutic proteins which are often difficult to make in other types of bioreactors and which are accepted as human by the body. This means that the body’s immune system is not triggered to defend against the new protein as it typically would against a foreign biological entity.
The most unique aspect of our platform lies is its capacity for high-quality, large-scale, and easy upscale-able production. It has been optimized in a way that allows us to generate large quantities of recombinant proteins in a controlled, easily transferrable, and scalable fashion.
Our innovative approach to each and every stage of the process, from concept through to treatment, and our methods are protected by a wide range of intellectual property.
In the case of RUCONEST®, our treatment for acute hereditary angioedema (HAE), our intellectual property not only covers the therapeutic compound itself, but also methods of production and purification, and therapeutic use in human medical indications, including (but not limited to) HAE and other diseases linked to C1 inhibitor deficiency or for which C1 inhibitor could provide a cure.
Aside from ensuring our products are of the highest quality, we are committed to ensuring that they are ethically produced and comply fully with the criteria set out by regulatory bodies.