Item 2. Properties
ITEM
2. PROPERTIES.
Office
Leasing Agreement
We
lease approximately 1,850 square meters (20,000 square feet) in the Jerusalem BioPark, located in the Ein Kerem Hadassah campus, next
to Hadassah University Hospital and Hebrew University’s Medical School. The facility includes laboratories, offices, and upstream
and downstream manufacturing suites for bulk production and limited capacity for single-dose syringe filling. We also have infrastructure
to support future product manufacturing processes and equipment. The manufacturing facility features modular, single-use infrastructure,
which enables us to adapt the facility to various manufacturing platforms (such as, for example, fermenters or bioreactors).
We
believe this existing property is sufficient for our needs in the foreseeable future and that we have the ability to renew our lease
at market terms and expand if required.
Fixed
Assets
Our
fixed assets are comprised of factory leasehold improvements, laboratory equipment, furniture, software and improvements in the leased
property. The accumulated depreciation as stated in our financial reports is deducted from the fixed assets value. Our fixed assets,
less deduction for the accumulated depreciation, were $11.2 million for the period ended on December 31, 2022 and $12.3 million for the
period ended on December 31, 2021.
Our
Main Laboratory
Our
facility in Jerusalem consists of laboratories, manufacturing suites, and offices. The laboratories include (i) an analytical lab, which
conducts quality tests on our products using our designated analytical methods;; and (ii) technical research and development lab for
manufacturing process development and scale up. The manufacturing suites, defined as “clean rooms”, include a fermentation
suite (“upstream”), a protein purification suite (“downstream”), a formulation suite, an aseptic, automated pre-filled
syringes/vials filling, and an equipment cleaning and sterilization suite. In addition, we have two GMP cold, and ambient temperature
storage areas.
BiondVax’s
modern cGMP pharmaceutical manufacturing facility is designed in a modular ‘Single Use’ technology concept enabling relatively
flexible production capabilities. Equipment units are mobile and can be replaced or relocated. The facility includes sufficient room
to conduct upstream, downstream and media / buffer preparation processes. Each clean room is segregated with a separate Fan Filter Unit
(FFU) designed to avoid cross contamination.
The
analytical lab is equipped with advanced equipment and machinery including computerized analytical devices for qualitative and quantitative
analysis, equipment for measuring light absorption properties for identifying substances, equipment for measuring weight, acidity and
temperature, and equipment for identifying replication of DNA sequences.
Our
laboratory also includes a separate technician room which contains our computers and software used to collect the data received from
our different devices for the purpose of analyzing it. The lab also contains refrigerators and freezers which are consistently monitored
and that are connected to a computerized control system. The production rooms are equipped with a fermentation facility, machinery for
filtering and concentrating proteins, a computerized system for the characterization and separation of proteins, as well as equipment
allowing us to work under sterile conditions.
The
facility also includes a Water for Injection (WFI) water purification system. The WFI system is controlled and monitored continuously.