After the discovery of DNA and recombinant DNA techniques in the past decades it became possible to transfer genes between different organisms, such as plants and bacteria. Scientists discovered how to transfer mammalian genes into the genetic material of other animals, and breed transgenic animals with specific (mixed) characteristics. This new scientific approach of recombining genetic material from different biological sources became known as recombinant DNA technology and the animals generated with such technology as transgenic animals.
Therapeutic proteins from milk
Pharming’s predecessor company GenPharm was founded to commercialize this innovative technology. The Pharming scientists were able to breed animals that could produce human-like proteins in their milk. The company further improved this technology and made it fully compliant with regulatory guidelines that apply in the United States and Europe.
For commercial purposes, Pharming also developed large scale purification methods for separating the human proteins from the other natural components in milk. The purification process for our lead product Ruconest was successfully up-scaled and transferred to the current manufacturing partner Sanofi Chimie. All production facilities and processes comply with regulatory GMP-guidelines and are suitable for large-scale production of the highest quality pharmaceutical products.
High quality in sufficient quantity
Pharming can produce complex therapeutic proteins in the mammary glands of rabbits or cattle and purify the protein from milk for its therapeutic application. This production method has the advantage of delivering high quality human proteins in sufficient quantities and consistently high quality. Pharming is the first company in the world to obtain regulatory approval for a recombinant protein pharmaceutical produced in milk of transgenic rabbits. The technology platform has been developed such that consistency of the product attributes is easily maintained through scaling up of the production process. Furthermore the transgenic rabbit platform has been optimized by Pharming to produce large quantities of recombinant proteins in a controlled, easily transferrable and scalable fashion.
There is a need in the industry for new means to produce over 900 protein therapeutics that are currently in development. Pharming believes that its production technology offers significant competitive advantages and will enable the development of better, safer and more cost-effective therapeutic products.
As of July 2013, Pharming has partnered the technology platform with The Shanghai Institute of Pharmaceutical Industry (SIPI); a Sinopharm Company.
This strategic collaboration for the development, manufacture and commercialization of new products based on Pharming’s technology platform, allows SIPI access to Pharming’s technology and know-how such that a joint global development of new products can benefit both parties.
Pharming Group NV (Pharming) is a Netherlands-based biotechnology company. The company operates through two business segments, including Recombinant proteins, and DNage. Pharming focuses on the development, production and commercialization of human therapeutic proteins to be used as innovative therapies. The company’s products are aimed at treatments for genetic disorders and surgical and traumatic bleeding. Pharming’s technologies include novel transgenic platforms for the production of biopharmaceuticals, as well as technology and processes for the purification and formulation of these biopharmaceuticals. The company’s commercial partners are: Santarus, Sobi, MegaPharm, Eczacibasi, Transmedic and Hyupjin. Pharming operates worldwide. In March 2014, it announced downsizing of the Dutch operations following from strategic re-emphasis on collaborative development efforts and out-sourcing of non-core activities.