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 APIAdalimumab. 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 1 st 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 Tank
2. Buffer tank,
3. Cell culture tanks -3,
4. Centrifugation & filtration
5. Cell Harvesting tank
6. Isolation & purification by chromatography
7. Viral Inactivation tanks
8. Ultrafiltration and Diafiltration
9. Bulk filtration
10.Freeze

Packing

Cell Bank

Raw material

Dispensing Room

MBP
Room

Cell culture room

room

Centrifugation & Filtration Room

Cell harvesting room

Isolation & purification

Viral deactivation room

Final filtration

Solidification

Ware house
GMP flow: