CODES

Safety

Industrialists, toxicologists, pharmaceutical engineers, --- containment studies….

Environmental programme-------------------------train operators &

High level Business Case:

To design a biopharmaceutical plant dedicated for the manufacture of the API-Adalimumab. The facility has to produce 108kg API per month, to meet its market demands.

The facility is using the Single-use technology platform to develop the product. Estimation of this process is 27g/liter when compared to 1st generation process, which yields 0.5-5gram/liter.

Process Description:

The process involves two stages.

First stage: is the up-stream process, which involves the production of the antibody by culturing bacteria isolated from a known cell bank.

Second Stage: is the down-stream process, which involves the purification of the antibody.

Production equipment arrangement:

1. Media preparation Tank2. Buffer tank,3. Cell culture tanks -3,4. Centrifugation & filtration5. Cell Harvesting tank6. Isolation & purification by chromatography7. Viral Inactivation tanks8. Ultrafiltration and Diafiltration9. Bulk filtration10. Freeze

Raw

material

Dispensing

Room

Viral deactivation room

Cell Bank

MBP

Room

Cell culture room

Centrifugation &

Filtration

Room

Cell harvesting

room

Isolation &

purification room

Final filtration

Pack

ing

Ware

house

GMP flow:

Solid

ifica

tion