02/14/202422 days ago
Columbia, Maryland, USA. – February 14, 2024 – Intralytix announced today that it has received the highly coveted Safe Quality Food (SQF) certification for food manufacturing. This comprehensive Hazard Analysis and Critical Control Points (HACCP)-based food safety and quality management certification sets Intralytix apart as the first and so far, the only bacteriophage company in history to attain such certification.
美国马里兰州哥伦比亚- 2024年2月14日–Intralytix公司今天宣布，该公司已获得梦寐以求的食品生产安全质量（SQF）认证。这项以危害分析和关键控制点（HACCP）为基础的全面食品安全和质量管理认证使 Intralytix 脱颖而出，成为历史上第一家也是迄今为止唯一一家获得此类认证的噬菌体公司。
Hal Warso, Director of Quality Assurance of Intralytix, Inc.Hal Warso, Director of Quality Assurance at Intralytix, commented: “SQF is an international food safety standard recognized by the Global food safety Initiative, which is approved as one of the benchmarked schemes for meeting very stringent requirements for food safety management systems worldwide. Intralytix receiving SQF certification is a testament to our dedication to producing safe and high-quality phage products for all our customers, and it further underscores the revolutionary impact that bacteriophage-based antimicrobials can have on ensuring a safer food supply chain.” Alexander Sulakvelidze, President and CEO of Intralytix, echoed the significance of this milestone, stating, “Our Company always has been on the forefront of everything bacteriophage technology-related, including acquiring and maintaining Kosher, Halal, and OMRI (organic) certifications for our phage products for food safety applications. We were the first phage company in the World to manufacture phage products in compliance with 21 CFR 117 cGMP standards. We have now added SQF certification to the list.” Dr. Sulakvelidze concluded: “This SQF certification is yet another milestone in Intralytix’s commitment to ensuring the highest standards of our phage products and food safety and quality. It further solidifies the Company’s position as a leader in the development and production of bacteriophage-based antimicrobials, providing innovative solutions to combat the growing global concerns of antibiotic resistance and foodborne illnesses.”
Intralytix’s bacteriophage-based antimicrobials offer a sustainable, environmentally friendly, and targeted approach for controlling harmful bacteria in food products, ensuring the safety and well-being of consumers in the United States. With SQF certification in hand, the company is poised to set new industry standards and continue its mission to provide innovative solutions to the global challenges of antibiotic resistance and foodborne illnesses.
Intralytix 基于噬菌体的抗菌剂为控制食品中的有害细菌提供了一种可持续、环保和有针对性的方法，确保了美国消费者的安全和健康。在获得 SQF 认证后，该公司将制定新的行业标准，并继续履行其使命，为抗生素耐药性和食源性疾病等全球性挑战提供创新解决方案。
About Intralytix, Inc. 关于 Intralytix 公司
Dr. Alexander “Sandro” Sulakvelidze, President & CEO of Intralytix.
Intralytix 公司总裁兼首席执行官 Alexander “Sandro” Sulakvelidze 博士。Intralytix is a cutting-edge United States biotechnology company dedicated to developing and producing bacteriophage-based antimicrobials. With a commitment to innovation and excellence, Intralytix is using its core bacteriophage technology platform to improve human health through the development and commercialization of innovative bacteriophage-based products for food safety, veterinary applications, human therapeutics, oral care, cosmetic, and dietary supplements/probiotic applications. The Company currently has the largest in the World portfolio of FDA- and USDA-approved phage products on the market for food safety applications. These products ensure the safety of foods against major foodborne bacterial pathogens such as Listeria monocytogenes, Salmonella spp., Shigella spp., Campylobacter spp., and Shiga toxin producing Escherichia coli or STEC (including E. coli O157:H7 and all “big six” STEC). Intralytix is actively expanding its nutraceutical product portfolio and is also working on developing phage therapeutics to combat various drug-resistant bacterial pathogens. To that end, Intralytix is currently the sponsor of three Investigational New Drugs (INDs) for randomized, controlled clinical trials designed to assess the safety and efficacy of oral administration of (1) EcoActive™ targeting adherent invasive E. coli (AIEC) in patients with inactive Crohn’s disease (NCT03808103); (2) ShigActive™ targeting Shigella in a human model of shigellosis (NCT05182749); and (3) VRELysin™ targeting vancomycin-resistant Enterococci (VRE) in healthy and VRE colonized subjects (NCT05715619). For more information, please visit www.intralytix.com or contact Dr. Alexander “Sandro” Sulakvelidze (410-625-2533, asulakvelidze@intralytix.com).
Intralytix 是美国一家尖端生物技术公司，致力于开发和生产基于噬菌体的抗菌药物。Intralytix 公司致力于创新和卓越，利用其核心噬菌体技术平台，通过开发和商业化基于噬菌体的创新产品来改善人类健康，这些产品可用于食品安全、兽医应用、人类治疗、口腔护理、化妆品和膳食补充剂/益生菌应用。目前，公司拥有世界上最大的、经美国食品及药物管理局（FDA）和美国农业部（USDA）批准的用于食品安全的噬菌体产品组合。这些产品可确保食品安全，防止主要食源性细菌病原体，如李斯特菌、沙门氏菌属、志贺氏菌属、弯曲杆菌属和产志贺毒素大肠杆菌或 STEC（包括大肠杆菌 O157:H7 和所有 “六大 “STEC）。Intralytix 正在积极扩大其营养保健品产品组合，同时还致力于开发噬菌体疗法，以抗击各种耐药细菌病原体。为此，Intralytix 目前是三项随机对照临床试验新药 (IND) 的赞助商，这些试验旨在评估口服 (1) EcoActive™ 针对粘附性侵袭性大肠杆菌 (AIEC) 的安全性和有效性。NCT03808103）；(2) ShigActive™ 针对志贺菌病人类模型（NCT05182749）；(3) VRELysin™ 针对耐万古霉素肠球菌（VRE）健康和 VRE 定植受试者（NCT05715619）。欲了解更多信息，请访问 www.intralytix.com 或联系 Alexander “Sandro” Sulakvelidze 博士（410-625-2533，asulakvelidze@intralytix.com）。