Antibody Production
In Vitro Antibody Production
Precision Antibody has broad experience in pilot scale, small scale, and large scale mammalian cell culture of hybridomas for production of monoclonal antibodies. Our facility is equipped with tissue culture bags, roller bottles, bioreactors, hollow fiber systems, and stirred tank fermenters. Our Precision Antibody Team will help you choose the best and most cost effective method to produce your monoclonal antibodies.
Pilot Antibody Production (1 mg to 10mg)
Most of our pilot antibody production is done in disposable bioreactor bags. The benefits of flexible bag containers include faster set-up, reduction of down time, and simplified validation. Disposable bags also greatly reduce the risk of cross contamination. These bags are a perfect solution for pilot scale productions. Our Precision Antibody team passes on these benefits to our customers in the form of lower costs for 1mg to 10mg antibody productions.
Small Scale Antibody Production (10mg to 500mg)
Small scale antibody production of your desired monoclonal antibodies can be reliably achieved in roller bottles or disposable bioreactors. Yields of monoclonal antibodies in roller bottles and bioreactors are clone dependent and vary on the cell line's growth and antibody production rates. Precision Antibody helps customers refine their growing conditions by assisting customers in their choice of media formulation. Whether selecting low bovine IgG fetal bovine sera, serum-free media, or animal protein-free media, Precision Antibody will help you hone your antibody production and deliver the required amount of antibody for your application.
Large Scale Antibody Production (500 mg to gram quantities)
Precision Antibody uses Fibercell System and Stir Tank Fermenters for industrial scale productions. We work with customers to determine antibody yield and media conditions. If necessary, we perform a pilot production to assess the antibody production rate. If the cell line is a low producer, it may be advantageous to re-clone and identify higher immunoglobulin producing clones (extra charge). The FiberCell® Systems hollow fiber system is the method of choice for the in-vitro production of 100 mg to 1 gram or more of monoclonal antibody.
Our stirred Tank Fermenters are used for projects over a gram. Again, Precision Antibody helps customers refine their growing conditions by assisting customers in their choice of media formulation - low bovine IgG fetal bovine sera, serum-free media, or animal protein-free media. Precision Antibody will help you hone your antibody production and deliver the required amount of antibody for your application.
CHO, NSO and HEK-293 Cells
Besides our custom antibody monoclonal production, Precision Antibody has experience in antibody production for CHO, NSO and HEK-293 cells. We work with customers to determine cell line characteristics, media requirements, and purification needs.
Antibody Production Methods
Below are some of the antibody production systems available at our Columbia, MD facility.
| Stationary Cell Culture | Gas Permeable Bag Method | Disposable Bioreactors | Hollow Fiber | Stirred Cell Bioreactors |
|---|---|---|---|---|
| T175 & T150 tissue culture flasks, vented | 50ml | CELLine Integra |
FiberCell Systems | Applikon 10L |
| Multi-Size Roller Bottles |
250ml | New Brunswick Bioreactors 10L |
||
| Nunc Cell Factory | 500ml 1 L |
New Brunswick Bioreactors 20L |
In Vivo Production
Precision Antibody also has a nude mice facility for ascities production. Occasionally, we encounter hybridoma cells that do not produce monoclonal antibodies in in vitro systems. Ascites production in nude mice can be used as an alternative method to produce these monoclonal antibodies. Additionally, ascites production often yields higher concentrations of monoclonal antibody. We prefer to use nude athymic mice for ascites production to eliminate the contamination of endogenous mouse IgG.
Antibody Purification
We offer several different methods of productions and levels of purification. In our basic IgG production/purification project, monoclonal antibody is purified on a Protein G affinity column using AKTA FPLC system. Purified antibody is tested for its antigen binding ability by solid phase EIA and the purity checked by SDS-PAGE. Protein concentration assessed by A280. Purified antibody is membrane sterilized. All of the purification methods, chromatogram, EIA data, Coomassie stained SDS-PAGE gel image and protein quantification data will be sent to our client with a Certificate of Analysis (COA).
We also offer additional services including endotoxin testing, sterility testing, size exclusion chromatography, isoelectric focusing, buffer exchange, protein quantification by micro BCA, IgG quantification by EIA, adjustment of IgG concentration to specification, vialing to specifications, and cell banking.
The following is a non-exhaustive list of antibody lot release testing offered:
- Chromatography for protein affinity
- SDS Page Analysis for Purity
- Concentration Determination
- Isotype
- FPLC Analysis for Purity and % Aggregates
- Isoelectric Profiling (IEF) for Identity
- Sterility
- Ion Exchange
- Antigen Affinity
- Size Exclusion Chromatography (SEC)
- Mycoplasma Testing
- Endotoxin Testing
- Biological Activity
- Conductivity
- pH Determination
- Freeze Thaw Recovery
- Custom Packaging (Vialing)
Documentation:
Each antibody production includes purification and a Certificate of Analysis.