Porcine trypsin (PTy), a starting material used in biologic drugs, should be tested just after it is produced to ensure material from a single infected pig doesn’t enter production batches, EU regulators say.
After PTy from multiple pigs is pooled, the contaminants produced by a single infected pig may be so diluted that they are not detectable by current testing methods, so early testing is critically important, the European Medicines Agency (EMA) says in final guidance issued March 3.
The agency hopes its final recommendations, effective Sept. 1, will help drugmakers better protect starter materials.
Bovine-, bacterial- and plant-derived trypsin may be acceptable alternatives for use in cell culture, with bacterial- and plant-derived trypsin presenting the safest options, the EMA notes.
However, those alternatives have not been assessed for suitability, quality, sterility and performance characteristics — or for associated risks such as prions, found in bovine species, the agency cautions.
Because PTy should be sourced from pigs “fit for human consumption,” it is imperative that batches of raw pancreatic glands be clearly labeled and documented with appropriate health certificates.
The Pty guideline follows FDA 2012 guidance on the use of porcine mucosa in drugs. That guideline, which was aimed at bolstering the heparin supply chain, encouraged drugmakers to trace supplies of porcine mucosa — the primary source of crude heparin — back to the slaughterhouse and provide regulators with the data.
Avoiding the use of infected materials in your products should be a top priority — how much do you know about the quality control processes actually in use in your facilities? Reserve your spot at Beyond GMP Training today.