EMA Releases New Draft Guideline on Ensuring the Quality of Animal-based Biotechnology

Posted 31 May 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) released a new draft guideline for sponsors obtaining biologically active substances from transgenic animals on 31 May, saying new guidance was necessary to help manufacturers achieve quality measures when using the biotechnology.

EMA explained the proposed guidance adheres to many of the same specific aspects of quality guidance already in place for other recombinant production systems. "As is the case with other biotechnologically produced active substances, both the production process and its control strategy play important roles in defining the quality profile of active substances produced by transgenic animals," said EMA.

Unlike traditional methods used in recombinant production systems, the use of transgenic animals represents several unique challenges with respect to the maintenance of quality, including the relative novelty of the technology, the generation and maintenance of the transgenic animal line and the impact of the production process on product reproducibility.

EMA's guidance notes a number of quality considerations the agency is looking for, including:

  • The specific rationale for the choice of host animal species and strain of genetic manipulation must be documented.
  • The homology of the transgene sequence to the natural human sequence should, if relevant, be documented and discussed.
  • The methods used to generate transgenic animals should be documented in detail.
  • Donor animals used for transgenesis should be "fit for purpose" and have their specific characteristics and origin documented. A line of animals should be generated from a "single genetic founder animal" unless the product requires multiple genetic founders.
  • The transgenic animal line should be genetically tested to detect deviant transgenic sequences and a breeding strategy established to ensure stability.
  • The sponsor should ensure the genetic makeup of any Master Transgenic Bank is stabilized through the use of inbred lines.
  • Companies should establish appropriate quality systems to ensure the maintenance of animals and the processing of production materials and animal products.
  • Steps should be taken to minimize potential contamination of harvested material with viral or non-viral agents.

Comments on the draft guideline are due by 30 November 2012.

Read more:

EMA - Guideline on quality of biological active substances produced by transgene expression in animals

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