nonGMP Monoclonal Antibody / Protein Production
MassBiologics provides nonGMP antibody and protein expression in mammalian cell culture. Cell culture can be performed in shake flasks, wave bags, 1L, 10L or 60L stirred tank bioreactors. We routinely manufacture materials at scales from a few milligrams to 10s of grams. We have developed several standardized programs that address our most commonly requested services. If the programs below do not meet your needs, please contact us and we will gladly design a program for your specific application.
Small scale antibody production from transduced cell pools with client supplied DNA for antibody gene sequences.
Included services:
- Cloning of antibody into vectors
- Large scale production of plasmids
- Electroporation of plasmids into MBL2 CHO cells / cell incubation (40 x 96 well plates)
- Pool selection: 1st round performed in 96 well plates (~250 mini-pools)
- Pool selection: 2nd round performed in shake flasks (~10 mini-pools)
- Scale up of top pool to seed 10L bioreactor
- Production in 10L bioreactor ≤ 5g (pool expected to yield 0.5 g/L)
- Purification by Protein A, buffer exchange into PBS, SDS-PAGE, A280 & bioburden analysis
Generation of stable clones with client provided DNA.
Included services:
- Cloning of antibody into vectors
- Large scale production of plasmids
- Electroporation of plasmids into MBL2 CHO cells / cell incubation (40 x 96 well plates)
- Pool selection: 1st round performed in 96 well plates (~250 mini-pools)
- Thaw and subclone pool / incubation of cells
- Clone selection: 1st round performed in 96 well plates (~100 clones)
- Clone selection: 2nd round performed in fed-batch shake flasks (~10 clones)
- Scale up to 2 clones with evaluation in 1L DasGips to select lead clone
- Produce WCB: ~50 vials; Assess/confirm productivity over 20 generations
Antibody production in 10L bioreactor from stable clone, ≤ 10g produced.
Included services:
- Thaw & scale up of clone
- Production in 10L bioreactor (yield dependent upon cell productivity)
- Purification by Protein A, buffer exchange into PBS, SDS-PAGE, A280 & bioburden analysis
Antibody production in 60L bioreactor, ≤ 40g produced.
Included services:
- Thaw & scale up of clone
- Production in 60L bioreactor (40L WV, yield dependent upon cell productivity)
- Purification by Protein A, buffer exchange into PBS, SDS-PAGE, A280 & bioburden analysis
Click here to request additional information regarding program timelines, costs and deliverables.