Earticle

초록

영어

Recombinant protein therapeutics have opened new therapy options particularly in disease areas where previously no, or only insufficient, therapies were available. Some 165 biopharmaceutical products have gained approval. In 2008, total recombinant protein-based drug sales were $94 billion, and are expected to increase to $145 billion in 2014. The rising pressure of cost-containment in all major markets is driving the uptake of generics and also creates a demand for biosimilars. And the patent and regulatory data protection periods for the first and second waves of biopharmaceuticals based on recombinant proteins have started to expire, opening the way for other manufacturers to place follow-on products. However, the cost and duration of development for biosimilars are much greater than for small-molecule generics, and presents a significant barrier to entry and a resistor of biosimilars market growth. On the other side, the innovator companies have been focusing on differentiated next-generation products which bring about convincing medical progress and make the first-generation, off-patent products obsolete, such as pegylated interferons, long-acting epoetins and fast-acting/slow-acting insulins. In this context, it has even been considered that competition in future indeed might not primarily be between innovators and price-cutting copiers, but rather with second-generation biopharmaceuticals (so-called 'biobetters') based on improved formulation or delivery systems, or derivatized biologics with improved performance. HanAll BioPharma had acquired a French company having proprietary technology for the design and engineering of therapeutic proteins that allowed the identification of key entry sites for proteolysis (or protease-mediated degradation). Through systematic point mutations at selected positions for proteolysis, Hanall was able to create novel versions of therapeutic proteins with decreased susceptibility to protease-mediated degradation in vitro and in vivo, while the biological activity was not affected. These protease-resistant molecules showed advantageous pharmacokinetic properties when administered to animals by different routes (subcutaneous, intravenous or even oral). The presentation concerns a novel IFN-α-2b (HanferonTM) derived from this technology.

저자

• Seung Kook PARK [ Biopharmaceutical Research Center, HanAll Biopharma, Suwon 443-270, Korea. ]

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국생물공학회 학술대회

• 간기

  반년간

• 수록기간

  1985~2013

• 십진분류

  KDC 476 DDC 576