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A closer look at antigens

  1. Top of page
  2. A closer look at antigens
  3. Reducing anti-drug immune responses
  4. Continous purification for a universal biomanufacturing platform

Ebersbach and Geisse, Biotechnol. J. 2012, 7, 1433–1443.

The term antigen is derived from “antibody generating”. This already highlights the pivotal role of antigens in the development of high-affinity and potent antibodies. Peptides, proteins, whole cells or even plasmid DNA can serve as antigens and can be applied in a variety of settings to elicit an immune response in vivo or select and mature an antibody molecule in vitro. Thus, the source, the quantity and quality of the antigen as well as its presentation significantly influence the outcome of antibody development. In this issue, Hilmar Ebersbach and Sabine Geisse (Novartis Institutes for BioMedical Research, Basel, Switzerland) address the most important aspects of antigen production and characterization with special attention to biochemical and biophysical quality criteria relevant for specific applications.

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Reducing anti-drug immune responses

  1. Top of page
  2. A closer look at antigens
  3. Reducing anti-drug immune responses
  4. Continous purification for a universal biomanufacturing platform

van Beers and Bardor, Biotechnol. J. 2012, 7, 1473–1484.

Adverse immune responses against biopharmaceuticals severely hamper their therapeutic efficacy. The clinical consequences include anaphylaxis, enhanced drug clearance and neutralization of the therapeutic protein as well as the endogenous human homologue. Therefore, a major challenge for bringing biopharmaceuticals to the market is minimizing the formation of anti-drug antibodies. It is important not only to assess the risk for immunogenicity in clinical phases, but also in ensuring the product quality throughout bioprocessing. To improve safety and efficacy of biopharmaceuticals, the protein critical quality attributes that affect immunogenicity need to be identified and controlled in the current context of Quality-by-Design (QbD). In this issue, Miranda van Beers and Muriel Bardor (Bioprocessing Technology Institute, A*STAR, Singapore) discuss the impact of protein structure, glycosylation, chemical modification and aggregation that should be controlled during bioprocessing to minimize immunogenicity.

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Continous purification for a universal biomanufacturing platform

  1. Top of page
  2. A closer look at antigens
  3. Reducing anti-drug immune responses
  4. Continous purification for a universal biomanufacturing platform

Godawat et al., Biotechnol. J. 2012, 7, 1496–1508.

The biotechnology industry currently uses two distinct manufacturing platforms for the production of therapeutic proteins: fed-batch processes for relatively stable proteins, such as monoclonal antibodies, and perfusion processes for relatively unstable proteins, e.g. recombinant enzymes. The emerging biotech business influences, such as cost, speed and flexibility, require a universal biomanufacturing platform. In this issue, Godawat et al. (Genzyme – A Sanofi Company, Framingham, MA, USA) discuss continuous capture purification using periodic counter current chromatography (PCC) as part of a universal, integrated and continuous biomanufacturing platform. Specifically, a theoretical approach towards designing a continuous capture operation using PCC is shown and applied to mAb and non-mAb proteins. The new platform offers several advantages, including low capital investment with smaller facility foot-print, better process economics by increased resin utilization, steady-state operation, minimal scale-up and hold times, as well as fewer and streamlined unit operations.

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