Optimized Antibody Recovery and Purification Methods

A special issue of Antibodies (ISSN 2073-4468).

Deadline for manuscript submissions: closed (31 March 2015) | Viewed by 7326

Special Issue Editor


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Guest Editor
Biological and Agricultural Engineering, National Center for Therapeutics Manufacturing, Institute for Plant Genomics and Biotechnology, Texas A&M University, College Station, TX 77843-2117, USA
Interests: recovery and purification of recombinant biomolecules, bioprocessing of microalgae and transgenic plants; process development and economics

Special Issue Information

Dear Colleagues,

Monoclonal antibodies (MAb) are the fastest growing segment of biotherapeutics, and together with the next generation of therapeutic antibodies are expected to reach worldwide revenues of more than $60 billion in 2015. MAb-based biologics developed and marketed in the past 20 years provided opportunities to treat cancer, autoimmune diseases, and several infectious diseases. To encourage biopharmaceutical industry to introduce new bioprocessing technologies and make antibody-based medications more affordable, many governments have developed polices for approval of follow-on biologics (biosimilars). The entrance of biosimilar antibodies on the market, recent success of antibody-drug conjugates, and increased MAb titers are expected to exert further pressure on downstream process capacity and productivity. In the past ten years, manufacturing cost reduction had been achieved by improving MAb titers, using more efficient Protein A resins, streamlining downstream processing by implementing single-use technologies, and achieving a modest increase in productivity. In spite of the development of reportedly disruptive downstream processing technologies that utilize monoliths, microporous hydrogels and polymers, and a combination of various non-chromatographic formats, expensive Protein A–based downstream processing trains still dominate manufacturing of monoclonal antibodies.

This Special Issue focuses on purification and recovery of various therapeutic antibody formats (antibody and antibody fragments, minibodies, antibody fusions, antibody-drug conjugates). The emphasis will be given on downstream processing methods that utilize disruptive technologies for recovery and/or purification of antibodies produced in mammalian cell cultures and Escherichia coli as well as less common production platforms such as plants and algae. Antibody recovery from whole cell cultures by precipitation and other non-chromatographic will be featured in this issue. Pretreatment of cell-free extracts for removal of DNA and aggregates that result in increased purification efficiency will also be considered.

Prof. Dr. Zivko Nikolov
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

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Keywords

  • therapeutic antibodies
  • antibody fragments
  • antibody conjugates
  • downstream processing
  • purification
  • recovery
  • antibodies from transgenic plants
  • antibodies from transgenic algae

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Published Papers (1 paper)

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Research

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Article
Model-Based Comparison of Antibody Dimerization in Continuous and Batch-Wise Downstream Processing
by Anton Sellberg, Frida Ojala and Bernt Nilsson
Antibodies 2015, 4(3), 157-169; https://doi.org/10.3390/antib4030157 - 10 Jul 2015
Cited by 8 | Viewed by 6920
Abstract
Monoclonal antibodies are generally produced using a generic platform approach in which several chromatographic separations assure high purity of the product. Dimerization can occur during the fermentation stage and may occur also during the downstream processing. We present here simulations in which a [...] Read more.
Monoclonal antibodies are generally produced using a generic platform approach in which several chromatographic separations assure high purity of the product. Dimerization can occur during the fermentation stage and may occur also during the downstream processing. We present here simulations in which a traditional platform approach that consist of protein A capture, followed by cation-exchange and anion-exchange chromatography for polishing is compared to a continuous platform in which dimer removal and virus inactivation are carried out on a size-exclusion column. A dimerization model that takes pH, salt concentration and the concentration of antibodies into account is combined with chromatographic models, to be able to predicted both the separation and the degree to which dimers are formed. Purification of a feed composition that contained 1% by weight of dimer and a total antibody concentration of 1 g/L was modeled using both approaches, and the amount of antibodies in the continuous platform was at least 4 times lower than in the traditional platform. The total processing time was also lower, as the cation-exchange polish could be omitted. Full article
(This article belongs to the Special Issue Optimized Antibody Recovery and Purification Methods)
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