Bonus BioGroup
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Tuesday, 29 March 2022 06:38

The Company's transition to the new Bonus BioGroup Center, in MATAM Advanced Technologies Park, Haifa, has been completed

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Bonus BioGroup (TASE: BONS) is a clinical-stage Israeli biotechnology company, engaged in research and development of biomedical tissue-engineered and cell therapy products.


Following an immediate report dated August 29, 2021[1], regarding preparations to increase the manufacturing capacity of the Company's products, Bonus BioGroup is pleased to announce that in March 2022, it has completed its transition to the new Bonus BioGroup Center. The new center, comprising an area of over ​​21,500 sq. ft., including ancillary areas, is located in MATAM Advanced Technologies Park, Haifa, Israel.

To the best of the Company's knowledge, the new Bonus BioGroup Center, is the most advanced facility in Israel for research, development, and manufacturing of tissue-engineered and cellular therapy products. The transition to the new Bonus BioGroup Center will significantly strengthen the Company in these areas. In addition, the transition will allow the Company to further increase its workforce, which has doubled in the last two years, while furnishing an innovative, creative, and supportive work environment.

About half of the area of ​​the new Bonus BioGroup Center is intended for industrial production in two separate facilities and full side-by-side production of the Company's two product lines: BonoFill™, a viable graft of human bone for the repair of bone defects, as well as MesenCure™, a cellular therapy designed to treat cytokine storms, including in severe Covid patients.

Each of the two production facilities set up in the new Bonus BioGroup Center, includes cleanrooms for the growing of cells and tissues, facilities for their storage, and the assembling and packaging of the products. The cleanrooms are constructed according to GMP standards at a Grade B level. In addition, they contain equipment and control systems that enable the continuous monitoring of each of the manufacturing stages to meet the production standards of cellular products intended for human therapy required by regulatory authorities in the US (FDA), Europe (EMA), and in Israel.

Alongside the cleanrooms, quality control (QC) laboratories were set, which meet the American (21 CFR, Part 11) and European (EudraLex) regulatory requirements. The safety and quality tests required for the Company's manufacturing processes and various therapy products shall be performed in these QC laboratories to reduce the Company's dependence on external service providers and strengthen its operational independence.

The manufacturing capacity in the two new production facilities may allow the Company to push forward to industrial-scale manufacturing of its two products, including the quantities required for clinical trials planned to run simultaneously in Israel and abroad and the commencement of commercial activities.

The manufacturing facilities are designed to implement automation and reduce human involvement in the production processes to increase productivity, improve reproducibility, product quality, and safety while saving the workforce and additional costs.

The other half of the new Bonus BioGroup Center is designated for research and development (R&D) activities as well as for regulatory, clinical, and management.

The new R&D laboratories, which include advanced equipment for the characterization of cells and tissues, provide the Company with innovative means for the isolation and expansion of cells and tissue engineering. The laboratories include separate areas for the research and for the development departments and shared work areas to promote the rapid transition of the Company's products from the research phase to the development phase and subsequently to the production phase.

These innovative measures, as a whole, are expected to strengthen the Company's ability to continue the development of new and groundbreaking technologies and therapies, such as BonoFill™ and MesenCure™, as well as to further the research and development of new applications for existing company products.

Dr. Shai Meretzki, CEO of Bonus BioGroup, said, "The world needs to continue to prepare for living actively alongside the Coronavirus and possibly more violent strains. This situation may last at least a few years. During this time, the requirement for vaccines for the general population, medicines for mild patients, and therapies for the treatment of severely-ill patients will be paramount. The combination of effective vaccines, medicines, and therapies, should allow us to return to a daily routine, as close as possible, to which we were accustomed before the epidemic. Returning to routine will give many patients the opportunity to undergo elective surgery, including surgical treatment for bone deficiency. Comprehending this reality, Bonus BioGroup is preparing for the industrial-scale production of its products, including BonoFill, a viable human bone graft to cure bone defects, and MesenCure to treat severe Covid patients."


 

Company estimations regarding forward-looking statements

The Company's assessments regarding the effect of increasing production capacity and changes in the research, development and manufacturing facilities, among others, on the Company's capabilities, as well as its assessments regarding compliance with regulations and transition to industrial-scale production and commercial marketing, are a forward-looking statement, as defined by the securities law of 1968, which is based on the Company's estimates and on the information in its possession at the time of reporting.  

There is no certainty that these estimates will materialize, in whole or in part, among others, due to dependence on global processes that may adversely affect the Company's manufacturing capacity, the actions of third parties, which are not under the Company's control, may delay the obtaining of permits from relevant authorities and / or change the relevant conditions and / or feasibility tests that the Company may conduct and / or delay in performing experiments and / or need to perform additional experiments and / or failure of experiments and / or technological changes and / or development and / or marketing of similar and / or more effective competing products and / or lack of availability of resources and / or realization of any of the risk factors associated with the research and / or experiment and / or its results.

Sincerely,

Bonus BioGroup Ltd.

By: Yossi Rauch (Chairman of the Board) and Dr. Shai Meretzki (CEO and Director)

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