Laboratory-produced antibodies mimic the natural antibodies produced by the immune system Y-shaped proteins composed of two light chains and two heavy chains connected by a disulfide bridge.

 

Host organism

Commercially, mAbs are often derived from CHO (Chinese Hamster Ovary) cell lines due to their capacity to perform post-translational modifications similar to those in humans.

Production system

The hybridoma technique, introduced in 1975, allows to produce large quantities of pure mAbs, mostly produced extracellularly. 

Raw materials

USP

Fed-batch: basal growth medium is supplemented with additional nutrients during the cell culture process. This approach enables the cells to reach high densities and sustain mAbs production over an extended period.

Continuous perfusion culture: constant feeding of fresh media and the removal of used media from a bioreactor. This allows for the maintenance of a steady-state environment, leading to higher cell densities and increased protein production.

Mabs22

DSP

Centrifugation step: mAbs are found in the supernatant phase after centrifugation due to their solubility and molecular size.
Affinity chromatography: Protein A capture.
Viral inactivation step: Low pH treatment or heat treatment or solvent/detergent treatment.

Mabs (1)

Final Formulation

1 Liquid Liquid
Formulation in buffered solutions Freeze-dried or spray dried require the addition of cryoprotectants and stabilizers
Advantage readily available for use without the need for reconstitution longer shelf life and decreased risk of protein aggregation

 

Packaging: There are typically three primary packaging configurations commonly utilized for mAbs drug products, which include: glass vials, glass pre-filled syringes (PFS), and glass cartridges.

Up Stream Process Down Stream Process Final formulation

CHO medium composition
Sugars: glucose
Amino acids: arginin, lysine, glutamine…
Inorganic salts: sodium, potassium, magnesium
Vitamins: B-vitamins and fat-soluble molecules
Trace metals: iron, zinc…
Buffers: HEPES, phosphate 
Serum

Quality ingredients
Pharma grade
Low endotoxin specifications
Full traceabilty

Buffers
Ensure a stable pH environment

Ion exchange
HEPES-buffered saline (HBS)
CAPS, MES, phosphate, or TRIS

Amino acids
Tonicity agents, Protein stabilizers
Antioxidants, Viscosity reducing agents
Glycine, proline, Arginin, Methionine, Arginine

Stabilizers
Trehalose, sorbitol, mannitol, sucrose, lactose, amino-acids, b-cyclodextrin, lipids

Surfactants
Minimize surface adsorption and adhesion to packaging surfaces
Reduce mechanical stress and decrease protein–protein interactions
Polysorbate 20, 80

Viscosity reducing agents
L-arginine HCl
Sodium chloride
Glycine / L-proline

Chelators
Mitigate the degradation caused by metals
EDTA and amino acids (methionine)

Antioxidants
Tocopherols, ascorbic acid

Sources:  

Schindele 2009 ; Kelley, B 2009 ; Mahé et al., 2022 ; Ghosh et al ; 2023.

 

 

 

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