Our facility is planned, designed and engineered based on current cGMP standards of international regulatory authorities such as the Pharmaceutical Inspection Co-operation Scheme (PICS). It will also conform to all local regulatory requirements.
Designed and built in a sequential process, the primary phase of our facility will be focused on vaccine formulation with its necessary associated support amenities. The second phase will see the construction of the vaccine manufacturing section. This will be followed by the third and final phase, the construction of the Research & Development as well as product development suites.
The formulation facility will be designed to include the following capabilities :
- liquid injection vials,
- lyophilised injection in vials and
- liquids in pre-filled syringes.
The facility will be capable of producing :
- 5 million vials per year of liquid injections,
- 10 million vials per year of lyophilised injections and
- 10 million syringes per year of liquids in pre-filled syringes.
The support amenities in this phase will include clean utilities, black utilities, HVAC system, BMS and building utilities.
The facility will also include a conjugation suite to expand the possibility of formulation up antigens requiring amplification. The final equipment of this suite will be determined according to the vaccines requiring conjugation.
Aside from the production lines and the utilities, the fill-finish facility will also have a proper storage and warehousing units for raw materials, finished product storage prior to shipment and other spares and consumables. A proper laboratory system will also be included in order to allow for quality assurance, quality control and in-process quality control (IPQC) activities to be conducted as per regulatory guidelines.