−Removed: Research Center and Tc Cattle Facility
−Removed: 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.
+Added: Research Center
+Added: As of December 31, 2022, our facilities include current Good Manufacturing Practice (cGMP) operations where drug products are manufactured in the clinical manufacturing facility located within the 60,000 square foot laboratory bay at the Sanford Research Center (the "Research Center") in Sioux Falls, South Dakota encompassing a 17,300 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.
−Removed: Transchromosomic (Tc) cattle used for hyperimmunization, and plasma collection are housed at our animal facilities we refer to as the “Pharm”.
+Added: TC Cattle Facility
+Added: Transchromosomic (Tc) cattle used for hyperimmunization, and plasma collection are housed at our animal facilities which we refer to as the “Pharm”.
The Pharm is a biosecure site dedicated to housing and rearing these animals.
10 unchanged sentences
Tc Bovine plasma is collected from the animals in designated areas at the Pharm.
−Removed: The areas are cleaned and maintained per 21CFR Part 600.11.
+Added: The areas are cleaned and maintained per the rules and regulations of the FDA.
The Fenwal Auto-C plasmapheresis machine (human device) is used to collect plasma.
1 unchanged sentence
Following plasmapheresis, the plasma bioprocessing bags are labeled and shipped to SAB manufacturing facility or to contract manufacturers.
−Removed: Our Tc Cattle Facility real property lease in Canton, South Dakota is currently set to expire in November 2038.
+Added: The Pharm 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.
−Removed: The lease covers approximately 45,602 square feet of office and laboratory space.
+Added: The lease covers approximately 49,600 square feet of office and laboratory space, with approximately 18,400 square feet of space dedicated to research and development activities.
The Company believes that its existing facilities and other available properties will be sufficient for its needs for the foreseeable future.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.