AlfaTech Big Book - Life Sciences 3.25.20

L I F E S C I E N C E S

MASSBIOLOGICS cGMP CULTIVATION SUITE* Boston, MA

Type : cGMP Manufacturing Size : 2,700 SF

MassBiologics constructed and commissioned a new 2,700 sf cGMP manufacturing area within the Mattapan II Facility (MTP2) for cultivation of toxins used to manufacture Tetanus and Diphtheria Toxoids Adsorbed (Td) vaccine. Since the toxin, Clostridium tetani is a spore-forming organism, the area design, controls and monitoring are based on FDA industry guidance document: “Manufacturing Biological Intermediates and Biologic Substances using Spore-Forming Microorganism” dated September 2007. The Culture Area is located in the basement of the MTP2 building along with process utilities and storage areas. Additional offices, IT server data center and a mechanical area containing HVAC is located on the second floor.

Engineered Systems Designed Include

• Clean room design • Single pass HVAC system • Spore and No-spore Laboratory spaces • RO/DI system • WFI system • Water Reclamation • BL-2 Labs

* Completed by AlfaTech principal during previous employment

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