Aseptic Drug Product
CMAB's Fill and Finish process service offers a dedicated state-of-the-art facility designed for clinical drug product.
The filling line (BOSCH) performs fully automated filling, stoppering, and capping for SCHOTT/Ompi vials ranging from 2R to 50R. The automated stoppering and capping function is configured to process 13mm and 20mm injection (serum) and lyophilization plugs.
The filling equipment product contact surfaces are engineered as single-use disposable and the ready-to-use container closure components are purchased pre-processed. Filling operations take place within an open restricted access barrier system (oRABS) which minimize operator and environmental risk to Critical Quality Attributes (CQAs) of exposed, in process drug product.
Filling equipment is validated for 2R to 50R glass vials. The BOSCH filling line are fully automated and EU compliant. Entire product path is disposable, including the fill needle. BOSCH filling pump enables highly accurate fills from 0.1mL to 50mL. Materials are from SCHOTT/Ompi and West Pharmaceuticals using their advanced technologies, like ready-to-use and B2-coating. Materials are manufactured according to well-established specifications for biopharma application.
CMAB have in-house capability to aseptically fill your Drug Product.
• Final processing of Drug Substance to Drug Product formulation.
• Filling under Grade A classification with Grade B background.
• Liquid and lyophilized drug products in vials.
• Full validation with media fills.
• Expedited filter compatibility testing with third party testing facilities.
800㎡ of classified cleanrooms accessed from restricted controlled-not-classified (CNC) area.
• Fully automated filling of Liquid and lyo in vials under ORABS Grade A with Grade B background
• Manual filling in Grade A isolator
• Supporting areas Grade C
• Preparation and Formulation
• Washing and sterilization
• Clean storage
• Vial washing and depyrogenation