Porcine trypsin guidance may apply retrospectively; EMA
In 2010 a new technique found DNA from porcine circovirus 1 (PCV1) in GlaxoSmithKline’s Rotarix and Merck & Co’s RotaTeq, both rotavirus vaccines. To cut the chance of viral contamination when using porcine trypsin, a pig-derived material, the European Medicines Agency is planning guidelines.
“Animal-derived materials can be contaminated with a wide range of biological agents and therefore it is strongly recommended that all these materials are appropriately selected, tested and treated for the inactivation and/or elimination of such agents”, the EMA said in its concept paper.
In 2003 the EMA adopted guidelines for cell culture reagents derived from cows and is now working on porcine trypsin. The concept paper is the precursor to publication of draft guidelines in the first half of next year.
Before drafting the guidelines the EMA must make several decisions. An unanswered question is whether to apply the guidelines to products already on the market. Applying the guidelines to existing products would mean retrospective testing of some vaccines and recombinant proteins.
The EMA has made similar decisions in recent years. Genotoxic impurities are another contaminant that improved testing has found in existing products. In its genotoxic impurity guidelines the EMA said retrospective testing is needed when there is “a cause for concern”.
Making recommendations
The EMA is more certain of other areas of the proposed guidelines. “Selection and testing is always associated with limitations with respect to exclusion of biological contaminants. Therefore, specific attention will be given on methods for inactivation or removal of pathogens”, the EMA said.
Guidelines should set appropriate targets for inactivation and removal of virus contaminants, the EMA said. The EMA also want to include outlines of the strategies for validation of inactivation and removal steps in the guidelines.
The consultation period closes on December 31 and the EMA is considering meeting with interested parties. Feedback gathered in the coming months will feed into draft guidelines the EMA plans to publish in the first half of next year. The draft guidelines will have a six-month consultation period.
