The Vector facility was built with regards to Health Canada regulations on Good Manufacturing Practices or GMPs -regulations that ensure drugs are consistently produced and controlled to meet quality standards on safety, purity and potency.
The 3000-square foot facility is divided into two suites connected by a pass-through with each suite having limited key access. The Cell Laboratory Suite is used for growth of uninfected host cells and preparation of starting materials. It contains a Grade A Biosafety Cabinet inside a HEPA-filtered cell culture room with positive air pressure. Once the cells are ready for infection, they are transferred to the Vector Laboratory Production Suite. Within this area is a Cleanroom Suite that is dedicated for the manufacture of clinical-grade vectors.
The Cleanroom Suite contains six classified areas and two Grade A biosafety cabinets within three rooms. The Production room adjoins a walk-in 37˚C warm room and is used for purification of Adenovirus vectors under GMP. The Vial Fill room consists of three areas and is used during manual aseptic filling of vectors into cryovials. The two rooms are physically segregated to prevent cross contamination of process intermediates.
The Production and Vial Fill cleanrooms are classified as Grade C areas. This was accomplished by using Biobubble technology which provides conditioned clean air to the classified areas. This technology works by creating barriers using environmental separation and high levels of mass air HEPA filtration. The HEPA power units draw in and filter air from the hard room and deliver HEPA-filtered air back into the cleanroom. The air is then recirculated back to the hard room through the strip door and under the vinyl walls and refiltered.
The design of the facility utilized quality considerations such as room air changes, airflow patterns and differential air pressure between rooms in order to meet air cleanliness classification requirements. Environmental monitoring for non-viable and viable air particulates demonstrate that the room environment meets the specification for Grade A cabinets in a Grade C background.
Figure 1. Robert E. Fitzhenry Vector Laboratory. The Cell Suite and Vector Suite are connected by a pass-through for transfer of cells and starting materials. The Vector Suite contains the Cleanroom Suite which is dedicated for the production of clinical-grade vectors. P/T – Pass through