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Austrianova focuses relentlessly on excellence

04-21-2022 12:44 PM CET | Health & Medicine

Press release from: Austrianova

Austrianova ISO 9001:2015 certified

Austrianova ISO 9001:2015 certified

SINGAPORE, April 21st, 2022

Austrianova (the SG Austria group, Austrianova Singapore and Austrianova Thailand) is pleased to announce that it has been awarded ISO 9001:2015 certification for the production of encapsulated and non-encapsulated cells its facility in Thailand. ISO 9001:2015 is an internationally recognized standard that ensures that products and services meet the needs of customers through an effective quality management system. ISO 9001:2015 is in addition to the company's Good Manufacturing Practice (GMP) compliance.

GMP is a product quality standard, with a focus on getting products with reproducible quality to the customer and it applies to all products such as pharmaceutical products (including cell therapies) and medical devices but also food and beverages, dietary supplements and cosmetics. In contrast, ISO 9001 is more focused on quality standards for running a whole business. This means that it includes manufacturing products of the right quality reproducibly but it also includes many other business goals. Thus ISO 9001:2015 certification is based on several quality management principles, including having a strong customer focus, involvement of high-level company management in quality, an outlined process-based approach, and ongoing improvement of these procedures and approaches.

Austrianova's decision to work towards ISO 9001:2015 accreditation demonstrates the Company's commitment to continually improving its products and services. Certification is only granted after an extensive company-wide audit that includes quality management system development, a management system documentation review, pre-audit, initial as-sessment, and clearance of non-conformances if any.

Austrianova, The Gemini #03-15, 41 Science Park Rd, Singapore 117610

About Austrianova
Austrianova (the SG Austria Group), is a biotech company with a global footprint and op-erations in Singapore and Thailand. Austrianova utilizes a novel and proprietary tech-nology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the im-mune system, allows cells to be easily transported, stored and implanted at specific sites in patients. The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. Bac-in-a-Box® is a similar protective device adapted for encapsula-tion of probiotic bacteria where it has human food and animal feed applications as well as rebalancing the microbiome due to its ability to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid. Austrianova now also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as "Fill and Finish" services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, anti-bodies, enzymes, recombinant proteins, exosomes etc).

Forward-Looking Statements
This release includes forward-looking statements regarding Austrianova (the Company) and its respective businesses. Such statements are based on the current expectations of the management of each entity. The forward-looking events and circumstances dis-cussed in this release, including completion of the public offering, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks affecting the Company, economic factors and the equity markets generally. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Austrianova undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. This is not an offer or solicitation to buy or sell any securities.

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