Purification Development

Laboratory technician working in the virus purification lab

Reach Our Mammalian Experts:

mammalian@lonza.com

  • Introduction

    Lonza's Purification Development team has extensive experience in the development and validation of purification processes for the large-scale manufacture of a wide range of therapeutic proteins. These include recombinant monoclonal antibodies, antibody fragments, fusion proteins and chemically conjugated proteins, hormones, enzymes and other proteins. To ensure the development of an integrated process, and to minimize the development timeline, purification development activities are performed in parallel with fermentation and assay development activities. A target specification for the product is first defined with the customer. Concurrently, fermentation, product recovery and purification processes are developed to meet this specification.

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  • Antibody Purification

    We have developed cGMP purification processes for over 100 different antibodies in past 25 years of mammalian development. These include a large number of human and murine IgG1, IgG2 and IgG4 molecules, and also IgM and IgG3 antibodies. For most antibodies, Lonza can implement a well-established platform process based on Protein A affinity chromatography followed by ion-exchange separation. Nanofiltration and low pH hold steps are included in the purification process for virus reduction. For IgM, IgG3 and certain other antibodies that have limited solubility or do not bind to Protein A, custom-made purification processes can be developed to meet your project needs.
  • Recombinant Protein Purification

    Lonza’s purification development group has developed purification processes for a wide variety of recombinant proteins. Many of these process development projects are undertaken in collaboration with the customer’s process development and analytical scientists. A wide range of chromatographic operations have been used for the purification of recombinant proteins (e.g. ion exchange, hydrophobic interaction, affinity, ceramic Hydroxyapatite, metal chelate, gel permeation, etc.). Virus removal and virus inactivation steps are included in all processes, and particular attention is paid to the characterization of post-translational modifications such as glycosylation.