EMA releases guidance on using transgenic animals as source for therapeutic proteins
Care is needed because experience is relatively limited, compared with longer-established biotechnology methods, says Agency
The European Medicines Agency (EMA) has released advice on how to ensure transgenic animals safely and reliably yield therapeutic proteins for pharmaceutical manufacturers.
The European Union (EU) body’s guidance says care is needed, because experience is ‘relatively limited’ compared with the longer-established biotechnology methods. As a result, market approval applicants ‘are advised to be appropriately vigilant towards transgenic system-specific aspects such as development genetics, generation and maintenance of the transgenic animal line and their impact on product reproducibility’, the EMA said.
Its advice focuses on quality issues affecting active substances produced from transgenes stably located in the nuclear genomes of animals, ‘including the selection, generation and control of the production animals and evaluation of freedom from adventitious agents’.
Regarding the breeding of such animals, it suggests using one animal to breed subject livestock, while testing them carefully to ensure they are sufficiently transgenic. The guidance notes: ‘Ideally the maximum number of generations between founder and production animals should be defined.’
The guidance says manufacturers should take special care when collecting blood or milk from source animals to avoid contamination, taking immediate action to remove such viruses, TSEs, mycoplasma, fungi and bacteria and constantly monitoring for their presence.
It added that applicants should present a risk analysis to medicine regulators on the contamination risk associated with the collection of their active ingredients from transgenic animals. Using this, the applicant ‘should propose an integrated step-wise strategy that reliably assures the microbial, viral and TSE safety of each batch of the transgenic medicinal product’.