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Manufacturing safety raises concern

Last week, pharmaceutical heads met as a result of a drug recall after a mix up of breast cancer pills. The mishap raises the question: ‘Is there enough regulation to protect patients?’

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 7192 bottles, each containing 30 tablets.

As a new generation of biopharmaceuticals go under trial in India, those in attendance at the Next Generation Pharmaceutical EU summit were concerned that as demand increases, manufacturing practices might suffer, meaning higher regulations might be necessary to keep track of manufacturing processes.

Biopharmaceuticals are made using living systems such as micro-organisms, plants and animal cells, and if any mistakes or alterations such as the contamination of ingredients occur during the manufacturing process, they are likely to lead to serious side-effects.

India’s Drugs and Cosmetic Rules 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.

Giles Snare (Head of Life Sciences, Bioquell) and 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.

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Biotherapeutics  •  Regulatory


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