Bovine Spongiform encephalopathies (BSE) – A disease in cattle belonging to a group of fatal neurodegenerative diseases affecting humans and animals called transmissible spongiform encephalopathies (TSEs) caused by an abnormal form of a cell protein called prion.

Why it Matters – Regulatory agencies require materials used to manufacture pharmaceutical products to be free of BSE/TSE.  This responsibility rests, at minimum, on the three organizations (1) the manufacturer of the material to fully understand and document the origin of each material and generate written certification statements, (2) the Contract Development and Manufacturing Organizations (CDMO) producing the active ingredient and product dosage form to collect and confirm the BSE/TSE statements and (3) the sponsor who is ultimately responsible for ensuring the safety of the dosage forms used in their clinical studies. 

Case Story – A CDMO outside of the United States manufactured five lots of active ingredient for a sponsor from 2015 through 2021 and was in the planning stage for additional lots in 2022.  The CDMO requested an urgent meeting with the sponsor to discuss concerns they had related to three regulatory starting materials (RSM).  During the meeting, the CDMO’s Quality Assurance representative stated that during an audit of the supplier of the RSMs, the supplier let slip that they were not the manufacturer of the three RSMs but simply relabeled the containers with their own labels.  When pressed for the name of the RSM manufacturer the supplier said the information could not be revealed because it was proprietary and was irrelevant since manufacturer was now out of business.  Further probing uncovered that the CDMO had never received the BSE/TSE certification documents from the manufacturer but had generated their own written statements on the CDMO’s letterhead assuming that the materials were likely suitable for use. 

The sponsor, now furious from the discovery of this information, demanded the CDMO investigate all possible chemical pathways by which the RSMs could have been produced, whether likely or not, and evaluate the potential risk to patients who were dosed with the product from 2015 to 2021.

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