Lonza PyroGene을 사용한 의약 완제품 FDA 승인 사례
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작성자 영사이언스 작성일18-12-03 13:50 조회1,987회 댓글0건관련링크
https://bioscience.lonza.com/lonza_bs/CH/en/Endotoxin-Detection/p/0000…
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안녕하세요. ㈜영사이언스입니다.
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.
확인하시고 추가로 궁금하거나 필요하신 내용 있으시면 ㈜영사이언스로 연락 주세요. 감사합니다.
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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