Hangzhou, Zhejiang, September 28, 2021 – Skyline has recently successfully completed a series of productions at various scales including 200 liters viral vectors in a single batch at its new GMP manufacturing plant. The successful process was part of the company’s multi-production line capacity that enables the parallel production of viral vectors up to thousands of liters per year and planning for the addition of new production lines for larger single batch capacity is underway. The successful productions, with consistent high quality and high yield cross-scale, -batch and -site, were achieved based on Skyline’s proprietary process technologies, which support the scalable and reproducible production of different AAV serotypes.
Skyline’s built-to-suit 70,000-square-foot GMP manufacturing facility, located in Hangzhou, Zhejiang Province, became fully operational in July 2021. It’s part of the company’s inception strategy to establish a fully integrated, proprietary AAV gene therapy platform from discovery to CMC to support its vision of developing and delivering high-quality innovative gene therapy products to patients in need.
To deliver on the strategy, Skyline has built robust process technology platforms and CMC capabilities that support its pipeline lifecycle from in-vitro research and in-vivo study to clinical development. Skyline’s state-of-the-art GMP manufacturing consists of multiple platforms for process and analytics that guide and control product quality, including an advanced plasmid process, a proprietary HEK293 cell lines, an advanced serotype independent viral vector process, and an efficient scalable downstream purification process. As an integral part of the holistic GMP-compliant manufacturing system, a comprehensive analytical platform and a rigorous quality control system were established and implemented to further safeguard the safety and quality of the viral vector products.
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Terms and Conditions | Privacy Policy
This website www.skytx.com (“Website”) is developed and operated by Skyline Therapeutics (Shanghai) Co., Ltd. (“Skyline”). Any entity or individual is advised to read this Terms and Conditions carefully before access, browse or use this website. Do not access this Website if you do not consent to the terms herein. By your continued accessing, browsing, or using this Website, you will be deemed to have understood and fully agreed to be subject to this Terms and Conditions and abide by the laws and regulations applicable to this Terms and Conditions.
You understand and agree that we may change this Terms and Conditions at any time without prior notice. Please review this Terms and Conditions periodically to make sure that you are aware of contents in the most up-to-date version. If you do not accept any revision to this Terms and Conditions, please stop visiting, browsing, and otherwise using the Website.
Your access to and use of this Website is also governed by the Privacy Policy of Skyline, which is hereby incorporated by reference.
ProhibitionsWhen using this Website, you shall (a) not infringe lawful interests of Skyline or other third parties, (b) not interfere with or attempt to interfere with, by any means whatsoever, normal operation of this Website, (c) not to attempt to decrypt, decompile, disassemble or reverse engineer any software contained on or constitutes this Website, (d) not to delete or change any published material by Skyline or any other person or entity on this Website, or (e) not to include or link to any material or information provided on this Website within the web framework.
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FOR THE USE OF THIS WEBSITE OR ANY INFORMATION OBTAINED OR DOWNLOADED FROM THIS WEBSITE, YOU SHALL AGREE THAT YOU WILL, AT YOUR OWN RISK, DECIDE WHETHER TO USE THEM. SKYLINE, ITS LICENSOR, SUPPLIER OR ANY THIRD PARTY MENTIONED ON THIS WEBSITE SHALL NOT UNDERTAKE ANY LIABILITY FOR ANY LOSS RESULTING FROM THE USE OR UNAVAILABILITY OF THIS WEBSITE, OR ANY MALFUNCTION, COMPUTER VIRUS OR LOSS OF DATA OCCURRED IN OPERATION OR TRANSITION.
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Termination of useSkyline reserves the right, in its sole discretion, to limit, suspend, or terminate this Terms and Conditions and your rights to use all or any part of this Website or Content at any time and for any reason, without notice or liability. Skyline reserves the right to change, suspend or terminate all or any part of this Website or Content at any time without notice or liability.
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Dispute ResolutionIn the event of any dispute, controversy or claim arising out of or relating to these Terms of Use or your use of the Website, Content or Services, you shall attempt in the first instance to resolve such dispute through friendly consultations.
In the event such dispute is not resolved through consultations within thirty (30) days after the date such consultations were first requested in writing, then you or we may submit the dispute for arbitration in Shanghai before the Shanghai International Economic and Trade Arbitration Commission(“SHIAC”) in accordance with SHIAC Arbitration Rules then in force.
The latest version of this Terms and Conditions is made and effective on November 26, 2021.
Skyline Therapeutics (Shanghai) Co., Ltd. (hereinafter referred to as “Skyline”, or “we”) respects the privacy of visitors (“You” or “Users) to our website www.skytx.com (“Website”), and therefore we establish this Privacy Policy (this “Policy”) pursuant to the applicable laws and regulations of China on the protection of personal information. This Policy applies to this Website and the services you may use on this Website. Please read carefully and make sure that you fully understand this Policy. If you do not agree to this Policy, please do not use this Website.
Information CollectionWhen you interact with us through this Website, we may collect your personal information to perform and respond to your requests to us. Under this Policy, “Personal Information” means any information by which you can be identified, such as your name, birthday, e-mail address, postal address, telephone number, or education background and professional experience (such as to submit resume online).
It is entirely your choice to provide us your Personal Information, and Skyline only collects the information you provide to us. According to this Policy, you will be deemed to have agreed to our use of your Personal Information when you visit this Website and provide us with your Personal Information.
Use of CookiesThis Website may use "Cookies" and other similar technologies. We store small data files called Cookies on your computer or mobile device for the normal operation of the Website. We will not use Cookies for any purpose other than those described in this policy. You may configurate Cookies under the help feature of the tool bar of most browsers. You may configurate most of the browsers to notify you when you receive a new cookie or choose to have your browser disable cookies altogether. Because Cookies allow you to take advantage of some of this Website’s essential features, we recommend that you leave them turned on.
Information UseWe will use such Personal Information solely for the purposes of maintaining this website, assisting you to register to acquire relevant services you may need, and responding to your questions and requests for information.
When we want to use Personal Information for other purposes not specified in this policy, we will seek your consent in advance. When we want to use the Personal Information collected for a specific purpose for other purposes, we will ask for your consent in advance.
Information Disclosures and SharingExcept as provided below, we will not share your Personal Information with third parties unless you have consented to the disclosure.
Sometimes we will ask some other companies or persons for service such as system technical support. To provide this kind of service, they may have access to your Personal Information but will not use the Personal Information for any other purpose.
We may share Personal Information to respond to duly authorized subpoenas or other lawful information requests of governmental authorities, including to meet national security or law enforcement requirements, to provide Internet security, or where required by law.
Security MeasuresIn accordance with relevant national standards, we implement security precaution measures that satisfies industrial standards to protect your Personal Information. Nevertheless, you shall remain responsible to make sure that your computer is sufficiently secured and protected from leaking your Personal Information.
Third Party LinksThis Policy applies only to this Website. This Website may contain links to other Websites ("Third-Party Websites") that are not operated or controlled by Skyline. The policies and procedures described herein do not apply to Third-Party Websites. Links to this Website do not imply that we endorse or have reviewed Third-Party Websites. We encourage you to contact these sites directly to obtain their privacy policy.
Minor’s PrivacyOur service does not address anyone under the age of fourteen (14). We do not knowingly collect personally identifiable information from minors under fourteen (14). In the case we discover that a minor under fourteen (14) has provided us with personal information, we immediately delete this from our servers. If you are a parent or guardian and you are aware that your child has provided us with personal information, please contact us so that we will be able to take necessary steps.
MiscellaneousThis Policy is made and effective on November 26, 2021, which is the latest version.
Skyline reserves the right to modify this Policy at any time by notifying Users, via the Website, of a new or updated Policy, and you can review the most up-to-date version on this Website.
Contact UsIf you have any questions about this Policy, please contact us at info@skytx.com.
