To aggregate or not? The challenges of implementing post-serialisation

In this Q&A, FutureLink speaker and operation director at pharmaceutical company IBI Lorenzini, Luca Pezzano, discusses the benefits of aggregation and the challenges of implementing it in a post-FMD deadline environment.

Can you give us an overview of IBI Lorenzini’s approach to aggregation?

IBI Lorenzini’s approach to aggregation is unique. We manufacture injectables for both the US (where aggregation is a must) and Europe (where aggregation is a nice to have) and we have decided to apply aggregation in both markets as we believe it adds value to both production and supply chain performance.

In your view, how widely has aggregation been adopted by the industry? (and specifically in Europe?)

In my opinion aggregation has not been so widely adopted in Europe. Companies that produce for the US market must use it, but only a few of those that manufacture products solely for Europe have implemented aggregation.

What is preventing the adoption of aggregation?

Companies that are yet to adopt aggregation believe it to be too complex and costly, without appreciating the potential return on investment it offers.

What are your views on aggregation?

I strongly recommend the implementation of aggregation in parallel with serialisation. Productivity on manufacturing and packing lines can actually increase and the benefit in the supply chain is significant. Additionally, pharma businesses will gain better insights and visibility into their supply chains and this can be extremely advantageous. For example, the ability to scan a singular code to identify an entire shipment makes the exchange of products through the supply chain significantly more efficient.

What are the benefits of choosing to implement aggregation?

In a production environment, if you have a reconciliation problem you can easily understand where the problem is thanks to full aggregation. In the supply chain, knowing exactly what product is where and in which parent batch, simplifies processes in the event of stolen or recalled products. Warehouse management for the serialised products can also be improved.

What are the potential drawbacks of implementing aggregation in a post FMD-deadline environment? Is it simpler to implement at the same time as a serialisation solution?

Implementing aggregation later often requires additional investment and potentially, the modification of the serialisation solution in place. This can halt production as software and manufacturing line equipment is revalidated.

It’s also the case that employees’ ways of working have to change again, doubling the change management activities when compared with implementing serialisation and aggregation simultaneously.

What are the potential challenges involved in equipping a line with aggregation capabilities?

Looking at aggregation as something that increases complexity is wrong and is a false reality. This is due to the fear of the unknown, but once businesses have implemented a serialisation solution, they are 90% of the way towards aggregation anyway.

What advice would you give to a company choosing whether or not to aggregate?

Start immediately and implement aggregation alongside serialisation - the benefits far outweigh any of the complexities.

What does the future hold for aggregation?

I’m quite sure that Europe will eventually require the adoption of aggregation.

Moreover, aggregation offers significant market advantages and efficiencies to manufacturers and its adoption will grow as these benefits are realised. The vision of a fully integrated, digital supply chain, where manufacturers have visibility of all their products until they are dispensed can only be achieved with aggregation.

Luca Pezzano will be speaking about aggregation at FutureLink Barcelona, which will take place 11-13 June 2019 and see leaders from across the life sciences industry gather in Europe to reimagine the future of healthcare delivery and explore how data-driven innovation is transforming business and patient outcomes. Keynote speakers will offer insight into the next wave of commercial, operational, and clinical care breakthroughs that are revolutionising the industry.

For more information and to reserve a seat, please visit FutureLink Barcelona.