Question

You are in charge of developing a process for the production of a potential blockbuster Monoclonal Antibody for cancer (the “product”). The antibody DNA has been transfected into a Chinese Hamster Ovary (CHO) cell line. Very little data has been collected on the cell line and production process and it is up to you to design a process from MCB vial thaw through Ultrafiltration/Diafiltration and Bulk Fill of the Bulk Drug Substance (BDS) that will produce a batch of at least 1 kg of product in the BDS. You will use the generic Process Flow Diagram for a monoclonal antibody product that was presented in numerous lecture slides as your guide, but it is up to you to provide the details. You will be graded on how thorough you are in the completion of the assignment. Your finished project should be in the form of a Process Flow Diagram that shows a picture of each process step (you must specify types of preculture vessels, bioreactor sizes, column sizes, filter sizes, make/model, etc.) along with a table with the process details including volumes, processing times, Critical Process Parameters (pH, DO, flow rate, etc.) and final testing that will be performed on the BDS to demonstrate Safety, Identity, Potency, and Purity.

I can do the majority of the assignment myself but a brief outline or knowledge of monoclonal antibodies would be appreciated!

Answer 1

Monoclonal Antibodies :

Monoclonal antibodies are antibodies that are made by identical immune cells that are all clonesof a unique parent cell.

Monoclonal antibodies can have monovalent affinity, in that they bind to the same epitope(the part of an antigen that is recognized by the antibody).

In contrast, polyclonal antibodies bind to multiple epitopes and are usually made by several different plasma cell (antibody secreting immune cell) lineages.

Bispecific monoclonal antibodies can also be engineered, by increasing the therapeutic targets of one single monoclonal antibody to two epitopes.

Given almost any substance, it is possible to produce monoclonal antibodies that specifically bind to that substance; they can then serve to detect or purify that substance.

This has become an important tool in biochemistry, molecular biology, and medicine.

When used as medications, non-proprietary drug names end in -mab and many immunotherapy specialists use the word mab anacronymically.