Serialisation, automation and data integration: Zenith talks manufacturing in 2017

By Dan Stanton contact

- Last updated on GMT

Image: iStock/AlexLMX
Image: iStock/AlexLMX

Related tags: Pharmacology

The implementation of serialisation regulations in 2017 are among the opportunities for drugmakers to improve manufacturing efficiencies, says IT and engineering firm Zenith Technologies.

“The life sciences sector is changing and we have good reason to be optimistic as we look ahead to the coming year,”​ Joe Haugh – CEO of Cork, Ireland-headquartered Zenith Technologies – told in-Pharmatechnologist.com.

“Reform driven drug price controls, patient centric care models and the concept of value based payment all place patients at the heart of drug development.”

Such changes will drive drug firms to continue advancing mobile technology, social media and big data analytics to create new ways to interact with patients and generate deeper levels of insight into treatments, he continued, but will also encourage manufacturers to adapt to changing demands.

“A key factor in driving greater productivity and flexibility this year will be the integration of data into the drug development and manufacturing process,”​ he said.

“In many cases, manufacturing takes place across diverse facilities and geographies, creating new operational challenges. The trend towards gene therapies, live viruses and personalised medicines also mean smaller batch sizes and the need for visibility across multiple lines and sites.”

Therefore, he told us, there will be a greater interest in developing and adopting automated systems.

Already a number of companies – including GE Healthcare​, Lonza​ and GSK​ – have already begun investing in developing and installing automation technologies, and this trend will continue as companies look to “future-proof their business.”

Serialisation

But a major driver of manufacturing improvements will be the upcoming serialisation demands.

In the US, the second phase of the serialisation rules of the Drug Supply Chain Security Act (DSCSA) comes into effect this year, requiring manufacturers to give unique serialisation numbers and bar codes to the smallest saleable unit of pharmaceutical product, and to every homogenous case of those drugs.

Meanwhile the EU Falsified Medicines Directive will require from 2018 a unique serialisation number and bar code on every saleable unit of drug product intended for dispensation to a patient – a batch of 48 boxes of blister pack pills will need 48 different identifiers, for example, not just one for the lot.

According to Haugh, while “representing one of the greatest challenges the industry is likely to face in 2017, this is also a huge opportunity for companies to introduce business improvements and increase efficiency.”

Recipharm​, Aesica​ and Zenith​ itself are among the service firms which have already begun investing in serialisation technologies ahead of these regulations.

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