SAB Biotherapeutics, Inc. 10-K

Item 2. Properties. Research Center and Tc Cattle Facility Our facilities include current Good Manufacturing Practice (cGMP) operations where Drug Substance/Drug Product is manufactured in the clinical manufacturing facility located within the 60,000 square foot laboratory bay at the Sanford Research Center in Sioux Falls, South Dakota encompassing a 5,400 square foot manufacturing area that includes the clinical manufacturing facility, -20°C plasma storage, and a controlled warehouse. The Research Center lease is currently set to expire in August 2024. Transchromosomic (Tc) cattle used for hyperimmunization, and plasma collection are housed at our animal facilities we refer to as the “Pharm”. The Pharm is a biosecure site dedicated to housing and rearing these animals. The physical surroundings are maintained in accordance with various governmental regulations. This site also includes surgical suite and plasma collection areas. Facilities are appropriate for cattle housing and give adequate protection from inclement weather conditions. Double barrier fencing (perimeter fencing and locked exterior gating) is designed to prevent Tc cattle from escaping or other unwanted animals from entering. Production animal pens consist of concrete feeding floors, water fountains and outdoor dirt lots. A biosecurity program is critical to the production of human pharmaceuticals from animals. The production herd is considered “closed” from a biosecurity perspective and inputs (feed, nutritional additives, medications, etc.) and outputs to the system are carefully monitored according to the appropriate regulations. A pest control program is instituted to control vermin. The biosecurity program is managed using a combination of procedural controls, facility design features (such as barriers, fencing and housing), controlled access and employee training into or out of the site. Tc Bovine plasma is collected from the animals in designated areas at the Pharm. The areas are cleaned and maintained per 21CFR Part 600.11. The Fenwal Auto-C plasmapheresis machine (human device) is used to collect plasma. Plasma is collected aseptically under standard sanitary conditions using a closed system and sterile bags to avoid microbial contamination. Following plasmapheresis, the plasma bioprocessing bags are labeled and shipped to SAB manufacturing facility or to contract manufacturers. Our Tc Cattle Facility real property lease in Canton, South Dakota is currently set to expire in November 2038. Corporate Headquarters The Company leases its corporate headquarters located at 2100 East 54th Street North, Sioux Falls, SD 57104. The lease covers approximately 45,602 square feet of office and laboratory space. The Company believes that its existing facilities and other available properties will be sufficient for its needs for the foreseeable future.