53Biologics

Analytical Services

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From early development to commercial manufacturing, we provide a wide range of analytical testing services to support your protein project.

53Biologics provide the protein analytical services you need

Our laboratories are equipped with the most advanced instruments and equipment complying with GMP requirements. Our experienced team ensures that every method suits the process requirements and the regulatory guidelines. We provide development, qualification, validation, and transfer methods according to the analytical method lifecycle for your recombinant protein analysis.

Our Analytical Solutions

We can implement, develop, validate and transfer a full quality control (QC) package for each step of your project:
  • Raw Material Analysis
  • Testing for Cell Line Development and Bank Characterization
  • In-Process Control (IPC) Analysis
  • Testing for Protein characterization
  • Release testing
  • Stability Studies

We can design a customized analytical package appropriate for your recombinant protein and further applications

Discover more about 53Biologics protein services

Strain & Cell Line Development

We have wide experience in E.coli, P. pastoris and fungal strain development and mammalian cell line development for the manufacturing of your biologic.
cell banking

Cell Banking

We are fully capable to produce and characterize Master Cell Banks (MCB) and Working Cell Banks (WCB) in our GMP compliant suits.

Process Development

Our experts in Upstream and Downstream Development provide personalized attention and ensure the most effective and innovative solutions for complex challenges.

Protein Manufacturing

We offer a wide range of manufacturing capacities for your enzymes, monoclonal antibodies, biosimilars or vaccines under GMP and non-GMP conditions.

If you need analytical services for your recombinant protein…