EMA considers controls for assessing materials for biomedicines

Published: 1-Aug-2013

Releases guidance on using starting materials and intermediates collected from different sources in the manufacture of non-recombinant biological medicinal products


Detailed guidance is being considered by the European Medicines Agency (EMA) to ensure that the initial processing of bio-based materials used in biomedicines does not cause safety problems.

EMA has released guidance on using starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products.

The agency wants to ensure that checks guarantee medicine efficacy and safety, which can be tricky when pharmaceuticals use a number of bio-based ingredient sources.

Information about the manufacturing process, beginning with the sourcing of the starting material (e.g. mucosa, urine) should be given for each intermediate, says the guideline. The level of detail should provide sufficient information depending on the stage of the process, with a focus on critical quality attributes and critical process parameters, traceability of supply and demonstrated [regulatory] oversight of the process.

The guidance says particular attention should be paid to intermediate ingredients from a number of sources and using multiple processing methods.

‘Where it is not possible to determine the critical quality attributes at the stage of these intermediates, testing for these quality attributes may be performed at a later stage in the manufacturing process,’ it suggests.

In addition, any differences between early manufacturing processes, e.g. additional purification/extraction step, process conditions, intermediates, materials and equipment, should be listed and justified.

The guidance says market approvals should only be given where ‘the quality of intermediates from variant processes [is] sufficiently assured, the final steps of the manufacturing process of the active substance is robust (and validated), and [they] produce a comparable active substance.’

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