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EMA Reflection Paper on Sourcing Biological Starting Materials


After the FDA has recently published a draft Guidance on Monitoring Crude Heparin for Quality (see our News from 29 February 2012), the European Medicines Agency EMA has now drafted a Reflection Paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products. The intention is to clarify "to which extent any variability in the early manufacturing steps for certain biological products would be acceptable", namely the variability for starting materials from living animals and process intermediates. In this context EMA states that "for some products such as heparins there is an increasing difficulty on finding starting materials suppliers in the EU and there is a need for manufacturers/MAHs to source outside the EU (e.g. China). As manufacturers inevitably need to have several suppliers, flexibility of sourcing in the biological substances of non-recombinant origin may be needed to ensure product supply."

To control this variability, EMA wants to get detailed information about the source and the manufacturing process. And the initial starting material needs to be defined.

For any heparin or LMWH from porcine origin, for example, porcine mucosa is defined as the starting material. Therefore, "Module 3 of the marketing authorization dossier should cover the whole manufacturing process starting from the sourcing of the mucosa. Aspects with potential impact on product quality and safety needs to be presented in sufficient detail e.g. species and country of origin, traceability from slaughterhouses/abattoirs, confirmation that the animals used are fit for human consumption etc." Basically that does mean that EMA wants companies to trace their heparin back to the slaughterhouse.

Other examples in the "Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products" reflect expectations for urine derived products and plasma derived products.

Compiled by
Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)