Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.
The European Union introduced a guideline in August 2016 on the monitoring of the safety of biological medicines on the market amidst industry worries about the ability of regulators to deal with quality deficiencies due to manufacturing variations in biopharmaceuticals. Manufacturing standards can have a bigger impact on the post-marketing safety and efficacy of biological medicines than those of chemically synthesized pharmaceuticals with which different producers can achieve a uniform quality.
“[With biologicals], the manufacturing process–including choice of cell line, raw or starting materials, fermentation and purification process, final formulation–is as much a determinant of the product’s quality as the active substance,” states the guideline. “Minor changes in any manufacturing step can affect the product quality and subsequently its safety and efficacy.” As a result, the guideline, published by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), constantly highlights the need to find the “root cause” of a suspected adverse drug reaction (ADRs) by tracing the product back not only to its manufacturer but also to its batch and the individual medicines within it. Read full article
