Manufacturing Safety Raises Concern

Last week Pharmaceutical heads met as a result of a drugs recall after a pill mix up of breast cancer pills. The drug, Fresenius Kabi’s Anastrozole, was made by the German company’s subsidiary in India. The ingredient mix up led to the voluntary recall of 7,192 bottles, each containing 30 tablets.

The mishap raises the question: Is there enough regulation to protect patients? As a new generation of bio pharmaceuticals go under trial in India those in attendance at the NGP EU summit were concerned that as demand increases, manufacturing practices may suffer, therefore higher regulations might be necessary to keep track of the manufacturing processes.

Biopharmaceuticals are made using living systems such as micro-organisms, plants or animal cells and if any mistakes or alterations like contamination of ingredients occur during the manufacturing process they are likely to lead to serious side-effects. India’s Drugs and Cosmetic Rules (DCR) don’t differentiate between synthetic and biopharmaceutical drugs. These concerns have been raised in the past; two years ago the FDA blacklisted the import and sale of 31 synthetic medicines that were manufactured in India. The FDA found “multiple, serious deficiencies” in the manufacturing processes.

“With every passing year, the pressure is building within pharma companies to go leaner and leaner across the value chain, from streamlining drug discovery, to more time efficient drug development to smarter clinical trial design and execution to leaner and leaner manufacturing. As the cost and time outlays necessary to bring a drug to market are forced to shrink due to many different factors.”

Giles Snare - Head of Life Sciences, Bioquell & Richard Lucas - Biopharmaceutical Process Specialist, Bioquell faced public and industry concerns head on. Given recent global instances of process contamination and the resulting serious consequences both commercially and regarding product risk, there is increasing focus from pharma and increased pressure from regulators being brought to bear on the maintenance of product integrity.

Contamination control is the primary focus within the industry at the moment, it is a complex process and an analysis of the potential points of weakness in modern pharma and biopharmaceutical environments will be key.

Joining Giles Snare were representatives from Pfizer, Simon Orchard – VP Biotech Operating, Sanofi Pasteaur, Pierre Fournier – VP Global Manufacturing Technology, Astra Zeneca, Eva Iden – Head of UK operations and head of Global Projects, Genzyme, Maarten Bas – Director Quality Systems EU and Johnson & Johnson, Johan Van Den Bosch, Senior Director External Manufacturing. Unfortunately, changes to international standards and legislation move cautiously but efforts to streamline global pharmaceutical regulations are stepping up. Mandated by the increasingly global nature of drug manufacturing, harmonization can only help the industry improve efficiency, but its ultimate goal is to ensure that every human on the planet has access to the medicines they need and the committee has made it their goal to accomplish this.