페이지 정보작성자 영사이언스 작성일18-12-03 13:50 조회702회 댓글0건
의약 완제품에 대해서 처음으로 기존의 LAL 시험법 대신 Lonza의 PyroGene™ (Recombinant Factor C Assay)을 사용해서 FDA 허가 받은 제품이 있어 관련 뉴스를 소개해 드리고자 합니다. FDA 허가 받은 제품은 Eli Lilly사의 Emgality™ (galcanezumab)로 성인 편두통을 예방하는 monoclonal antibody drug 입니다.
PyroGene™은 2003년 Lonza에서 처음으로 출시 되었지만 약전에 등재되지 않은 시험법이기 때문에 사용하는 것이 쉽지 않았습니다. 그러나 미국 FDA에서는 2012년에, EP에서는 2016년에
Recombinant Factor C시험법이 LAL 시험의 대체시험법으로 등재 되었고, 올해 첫 reference가 생기게 된 것입니다.
아래 관련 기사 및 PyroGene™ 제품의 자료들을 참고하셔서 새로운 시험법의 도입을 고려해 보시면 좋을 것 같습니다.
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FDA Approves First Drug Using the Recombinant Factor C Assay for
Walkersville, MD (USA) / Basel (CH), 8 November 2018 – Lonza announced today that the recombinant Factor C (rFC) Assay has
been used for endotoxin testing of Eli Lilly’s Emgality™ (galcanezumab), the first drug approved by the U.S. Food and Drug
Administration (FDA) to have been released using this method instead of
traditional Limulus Amebocyte Lysate (LAL) - based methods. Emgality™ is a monoclonal antibody drug treatment for the prevention of
migraine in adults.
In 2003 Lonza launched the PyroGene™ recombinant Factor C Assay, the first endotoxin testing method to utilize a recombinant form of Factor C, the first component in the horseshoe-crab clotting cascade activated by the presence of endotoxins. As an animal-free method, the PyroGene™ Assay offers a more sustainable alternative to LAL-based tests that use the lysate obtained from horseshoe crab blood as their main ingredient.
"The recent FDA approval of Emgality™ marks a significant breakthrough in establishing the recombinant Factor C Assay as the non-animal method of choice for the identification of contaminating endotoxins in drug products," said Lakiya Wimbish, Product Manager for Lonza’s PyroGene™ Recombinant Factor C Assay. "This development serves as an official confirmation that the recombinant Factor C method can be as accurate, sensitive and specific as LAL-based methods, while helping to secure the supply of natural resources."
Allen Burgenson, Lonza’s Global Subject Matter Expert for Endotoxin Testing Solutions, said, "Lonza is the commercial innovator in bringing recombinant technology for endotoxin testing to market. This milestone accomplishment in advancing rFC technology will help to ensure the sustainability of the world’s horseshoe crab species. The three species of horseshoe crab found in Asia (Carcinoscorpius rotundicauda, Tachypleus tridentatus and Tachypleus gigas) are in serious decline due to overfishing, habitat loss and their use as a regional food. As these species become depleted due to a lack of regulatory oversight, countries such as China that use them to prepare Tachypleus Amebocyte Lysate (TAL) will look to the North American species, Limulus polyphemus, to fulfill their ever increasing needs in order to release non-pyrogenic pharmaceutical products to the market. Use of recombinant products, such as recombinant Factor C for endotoxin detection will greatly reduce the pressure on these species."
More information about Lonza’s PyroGene™ Recombinant Factor C Assay is available on the Lonza website: www.lonza.com/pyrogene
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