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Quality Control

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Quality Control

Icosagen offers a broad range of tailored services for the development and production of recombinant antibodies, including complex antibody formats.

Though the challenge is with the latter, as many hard-to-express antigens also require very customized approach to purification and storage buffer formulation. For each step Icosagen has highly qualified personnel focused on solving any challenges.

Analitycs plays a key role in protein production in order to get functional proteins with high purity. Icosagen has dedicated department of analytics to ensure the best quality of our recombinant proteins - both antibodies and antigens.

Recombinant antibody production services includes the possibility to change antibody subtype or host specificity, and to generate various types of antibodies, such as human IgG1, IgG2, IgG4, mouse IgG1, IgG2a, IgG2b, IgG3, rat IgG1, IgG2a, rabbit IgG, chicken IgY, chimeric antibodies, antibody fragments, single chain molecules, bispecific antibodies (bi- scFV-Fc, DVD-Ig, Crossmabs), etc.

There are two options for recombinant antibody production by using QMCF Technology:

1.

Enhanced transient production of recombinant antibodies

is used to deliver up to hundreds of milligrams of purified antibody within 3-4 weeks starting from vector cloning.

2.

Stable episomal production

is used to scale up the production volumes up to 40 liters cost effectively, and to deliver multiple gram quantities of purified antibody. In this case, also episomal production cell bank can be generated, which allows to omit transfection completely when repetitive and constant supply of the same antibody is required with consistent reproducibility.

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Transient production includes:

  • cDNA optimization and cloning into transient pQMCF expression vector
  • Chemical transfection of the QMCF/CHOEBNALT85 cell line and expression control 48 hours after transfection
  • Optional culture expansion (up to 2.5 fold) and recombinant antibody production
  • Harvesting and purification
  • Product analysis and characterization
  • Weekly updates, and detailed reports

Stable production, including selection and cell bank generation:

Each project will be tailored according to the customer's needs; Work-flow below describes the most common options available under the recombinant antibody production service.

  • cDNA optimization and cloning into transient pQMCF expression vector
  • Electroporation of the QMCF/CHOEBNALT85 cell line and expression control 48 hours after transfection
  • G418 selection and generation of production cell bank (stable episomal pool)
  • Culture expansion to the final production volume and recombinant antibody production
  • Harvesting and purification
  • Product analysis and characterization
  • Weekly updates, and detailed reports
Step 1: Expression vector construction and expression analysis. If needed, antibody variable regions should be synthesized

Synthesis of variable region DNA

Expression vector construction

Transfection and expression analysis

Timescale: 1 week if cDNA is available, 4 weeks if variable regions need to be synthesized
Deliverables: Expression/secretion data 48h transfection

Step 2: Antibiotic selection, cell bank generation and production

Antibiotic selection. Production volume scale-up

Production cell bank generation

Protein production. Production analysis

Timescale: 3 weeks. In case of transient production (without selection and cell bank generation) — 1 week.
Deliverables: Antibody constaining supernatant, analysis data

Step 3: Antibody purification and characterization

Antibody purification

Antibody characterization

Timescale: 1 week
Deliverables: Purified antibody, QC data, characterisation data, detailed report

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+1 415 548 6625

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