ArcticZymes与ReiThera在COVID-19候选疫苗项目提供SAN HQ核酸酶达成协议
2020-11-27

ArcticZymes与ReiThera在COVID-19候选疫苗项目提供SAN HQ核酸酶达成协议

2020.07.02,特罗姆瑟】ArcticZymes AS (OSE:AZT)ArcticZymes Technologies ASA的子公司。该公司宣布已与疫苗生产专家ReiThera Srl(意大利罗马)达成供应盐活性核酸酶(SAN-HQ)的协议,支持ReiThera用于开发和生产新冠病毒候选疫苗。这种候选疫苗基于ReiThera的病毒载体技术,计划很快进入临床试验。

SAN-HQ已经在依赖病毒载体的生物制药市场树立了自己的地位,客户通过病毒将遗传物质导入细胞以治疗或预防疾病。出于安全考虑,监管机构要求制造商在最终制剂中尽量减少和控制外源核酸杂质(未被载体封装的DNARNA)的数量。因此,一般会在下游病毒处理过程中用一种或多种核酸酶处理,来消化外源DNA。外源DNA也会导致病毒颗粒聚集,从而降低载体的产量和效力。减少病毒聚集的关键策略之一是将病毒保持在高盐浓度。与其他商业核酸酶不同,SAN-HQ可以在高盐浓度下高效地消化核酸。此外,SAN-HQ的使用浓度较低,这意味着使用后需要从病毒中去除的酶量更少,这是另一个关键优势。

具体来说,病毒疫苗的制造过程是一个复杂而漫长的多阶段过程,有许多步骤。SAN-HQ用于这一过程的一部分,但最终不会作为最终治疗性疫苗的一部分。因此,供应协议涉及提供这一必要组分,以简化部分过程。

ReiThera公司与德国的白血细胞公司(Leukocare AG)和比利时的Univercells公司(Univercells S.A.)组成了一个泛欧洲联盟,以快速开发其针对新型冠状病毒SARS-CoV-2的疫苗。SARS-CoV-2会导致COVID-19

 

ArcticZymes AS, CEO, Jethro Holter:

很高兴扩大我们的合作关系,支持ReiThera和它的联盟合作伙伴,快速跟踪它开发新型冠状病毒SARS-CoV-2疫苗的项目进展。ReiThera是欧洲领先的基因疫苗研发公司,专注于利用ArcticZymesSAN-HQ等最佳技术,将创新疗法推向市场。我们期待支持ReiThera的疫苗开发和未来的商业化。

该协议与我们扩大SAN-HQ生产规模的努力完美契合。20205月,挪威创新基金授予ArcticZymes,用于扩大SAN-HQ生产规模。生产规模的扩大,将满足我们的合作伙伴如ReiThera未来的商业需求。

 

ReiThera’s Project Manager, Marco Soriani:

“ReiThera研发新型冠状病毒(COVID-19)疫苗的努力依赖于其与主要制药利益攸关方的牢固伙伴关系,如ArcticZymes,后者提供了关键技术,以确保始终如一的高质量产品。我们期待与ArcticZymes在这个重要的产品开发项目上合作,该项目旨在应对全球COVID-19大流行。

 

关于ArcticZymes AS

ArcticZymes开发、生产和销售用于分子研究、体外诊断(IVD)和治疗的新型重组酶。公司专注于新型和高质量的酶技术,在快速的技术发展创造了对新型和改良酶的强劲需求的增长市场。其酶的一些独特特性包括热不稳定性和在具有挑战性的环境中的活性,以及可整合为商业合作伙伴的可定制、工程化的新特性。

 

所有ArcticZymes产品均通过ISO13485认证。

更多信息,请访问:www.arcticzymes.com

 

关于ReiThera Srl

ReiThera Srl是一家致力于基因疫苗和先进治疗药物的技术开发、GMP生产和临床转化的生物技术公司。该公司的管理和科学团队已经开发了一个高度创新的技术平台,该平台基于针对RSV和埃博拉等多种传染病的猿猴腺载体疫苗。ReiThera由一个经验丰富的管理团队领导;他们在以前的成功企业,如Okairos (GSK收购)中合作多年,并在含有灌装设备和质量控制实验室的cGMP设施中,拥有可扩展的病毒载体制造流程方面的长期生产经验。ReiThera也是一个泛欧联盟的成员,该联盟致力于开发和大规模生产一种针对COVID-19的腺病毒载体疫苗。

ReiThera在意大利罗马设有总部、研发实验室和GMP设施。

 

原文引用:https://arcticzymes.com/arcticzymes-has-entered-into-an-agreement-with-reithera-to-supply-its-san-product-for-reitheras-covid-19-vaccine-candidate/

ArcticZymes has entered into an agreement with ReiThera to supply its SAN product for ReiThera’s COVID-19 vaccine candidate

 

Tromsø, 02 July, 2020: ArcticZymes AS (OSE:AZT), a subsidiary of ArcticZymes Technologies ASA, announces that it has entered into a supply agreement with vaccine specialist ReiThera Srl (Rome, Italy) for the supply of Salt Active Nuclease (SAN-HQ) to be used in the development and manufacturing of ReiThera’s novel vaccine candidate against COVID-19. The vaccine candidate, which is based on ReiThera’s viral vector technology, is scheduled to enter clinical trials soon.

 

SAN-HQ has established itself within the viral vector-based biopharmaceutical segment, where viruses are used to deliver genetic material into cells to treat or prevent disease. Due to safety concerns, regulators require manufacturers to minimize and control the amount of exogenous nucleic acids impurities (DNA or RNA not encapsulated by the vector) in the final dosage. Therefore, one or more nuclease treatments are often implemented in the downstream processing of the virus, in which the nuclease digests exogenous DNA. Exogenous DNA can also cause the viral particles to aggregate, which reduces both yield and potency of the vector. One of the key strategies to reduce aggregation involves keeping the virus at elevated salt concentrations. Unlike other commercially available nucleases, SAN-HQ digests nucleic acids with high efficiency at high salt concentrations. Furthermore SAN-HQ is utilized at much lower quantities which means less enzyme needs to be removed from the virus following its use which is another key advantage.

 

To put it into context, the manufacturing process of viral vaccines is a complicated and lengthy multi-stage process with many steps. SAN-HQ is utilised for one part of this process and does not end up as part of the final therapeutic vaccine. Hence, the supply deal relates to the provision of this essential component to streamline part of the process.

 

ReiThera, together with Leukocare AG (Germany) and Univercells S.A. (Belgium), has formed a pan-European consortium to fast-track the development of its vaccine against the novel coronavirus SARS-CoV-2, which causes COVID-19.

 

ArcticZymes AS, CEO, Jethro Holter said:

 

“We are delighted to expand our relationship in supporting ReiThera and its consortium partners with fast tracking its activities to develop a vaccine against the novel coronavirus SARS-CoV-2. ReiThera is a leading European company in genetic vaccine development focused on bringing innovative therapeutics to market via leveraging the best technologies such as ArcticZymes’ SAN-HQ. We look forward to supporting ReiThera in the development and future commercialisation of their vaccine.”

 

“This agreement seamlessly fits with our efforts to scale up SAN-HQ which is supported by the Innovation Norway funding recently granted to ArcticZymes in May 2020.  The timely scaling of SAN-HQ production will satisfy future commercial demand from our partners such as ReiThera.”

 

ReiThera’s Project Manager, Marco Soriani, said:

 

“ReiThera’s effort to develop a vaccine against the coronavirus that causes COVID-19 relies on its solid partnerships with key pharmaceutical stakeholders, such as ArcticZymes, which provide crucial technologies to ensure a consistently high-quality product. We look forward to working with ArcticZymes on this important product development program, which aims to tackle the global COVID-19 pandemic.”

 

-ENDS-

 

About ArcticZymes AS

 

ArcticZymes develops, produces and markets novel recombinant enzymes for use in molecular research, In Vitro Diagnostics (IVD) and therapeutics.

The Company focuses on novel and high-quality enzyme technologies in growth markets where rapid technological developments are creating a strong demand for new and improved enzymes. Some of its enzymes’ unique features include heat lability and activity in challenging environments as well as customized, engineered novel features which can be integrated to power the technologies of commercial partners.

All ArcticZymes products are ISO13485 certified.

For more information, please visit: www.arcticzymes.com

 

About ReiThera Srl

 

ReiThera Srl is a biotech company dedicated to the technology development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies. The company’s management and scientific teams have developed a highly innovative technological platform based on simian adeno-vectored vaccines against several infectious diseases, such as RSV and Ebola. ReiThera is led by an experienced management team that has worked together for many years in previous successful enterprises, including Okairos (acquired by GSK), and has a long-standing expertise in scalable processes for viral vector manufacturing, supported by a cGMP facility inclusive of filling suite and quality control laboratories. ReiThera is also part of a pan-European consortium focused on the development and large-scale manufacture of an adeno-viral vector vaccine against COVID-19.

ReiThera has its headquarters, R&D laboratories and GMP facilities in Rome, Italy.

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