Serialisation challenges and opportunities for MAHs and CDMOs


Speaking at FutureLink Munich in June, IBI Lorenzini’s Operations Director, Luca Pezzano, discusses the company’s serialisation journey from both a marketing authorisation holder (MAH) and CDMO perspective, exploring both the challenges and opportunities

Serialisation challenges and opportunities for MAHs and CDMOs

Celebrating its 100-year anniversary in 2018, IBI Lorenzini is an Italian, privately owned pharmaceutical company that's active in the market of injectable sterile beta-lactam antibiotics as an MAH and contract development and manufacturing organisation (CDMO), working in the production of recombinant recombinant proteins.

IBI Lorenzini’s serialisation journey to date

IBI started its serialisation journey in 2016 by scoping out the project and beginning vendor and machine selection in preparation for the Drug Supply Chain Security Act (DSCSA).

A decision was taken early on to effectively split the project in two and develop each in parallel. The first of these projects focused on site and line readiness (levels 1-3), upgrading and adding devices where necessary, implementing device management software and line management systems.

The second was dedicated to enterprise systems and network connectivity (levels 4-5).

Both projects have now fully integrated, machine qualification has been completed and IBI has completed all its partner connections in the US.

In preparation for the European Falsified Medicines Directive (EU FMD), IBI has started the integration process with its CMO partners, discussing data exchange processes and redesigning artwork to include tamper evidence. The company aims to be ready for FMD serialisation by the end of 2018, ahead of the February 2019 deadline.

Serialisation challenges

As IBI Lorenzini ships products to both the US and EU markets, IBI had a bit of a head start when it came to FMD readiness — having already implemented line upgrades and incorporating a few lessons from DSCSA implementation.

However, many businesses are not ready for FMD. In a statement released on 12 March 2018, the European Medicines Verification Organisation (EMVO) said that only a fifth of pharma companies had signed participation agreements and begun the process of on-boarding to the EU hub. The figure is well behind the EMVO’s target at this point in the schedule and the reasons for this are manifold.

One of the more prominent issues is the lack of recognition and understanding of serialisation complexity and the time it takes. Many think it’s simply a matter of adding a QR code to a carton; the reality is that data exchange, connection, package design and artwork amends are all parts of a big and complex puzzle as well as being complicated and time consuming in their own right.

Vendor availability is also a big issue. In the results of TraceLink’s Global Drug Supply, Safety and Traceability (GDSST) survey, it was found that 88% of EU FMD CMOs are concerned that equipment shortages will affect their ability, or customers’ ability to comply with the regulations.

Issues around vendor availability are compounded by the fact that most companies are starting their serialisation projects too late and vendor resource is increasingly finite.

To illustrate this point, IBI selected machine and system vendors in 2016 and reached the validation stage in early 2017. IBI found that selecting, installing and validating line and site level hardware and systems can take 12-months; without a dedicated team, it will likely take longer.

Implementing enterprise systems and network connectivity can take 6–9 months. If everyone is using the same connection partners and a network-tenant approach, this time can be significantly shortened.

Given that the EU FMD deadline is less than a year away, any business that is not well into its serialisation project already is going to face incredible pressure.

Time is now the biggest enemy and risk is increasing day-by-day as time decreases and businesses hurry processes through without proper testing and validation.

For businesses in the early stages of their serialisation project, there are four essential elements that they must have in place to underpin project success:

  • a deep knowledge of the regulation – this may come from existing in-house expertise, specialist third-parties or be recruited into the business
  • a product team with clear definition of roles and responsibilities
  • a clear system design with scope for broader benefits
  • a robust implementation plan that factors in line validation, partner connections and data qualification as well as connecting to the EU hub.

Shifting to an opportunity mindset

Although regulatory readiness is no doubt the sole focus of most pharma and CMO businesses in the EU currently, there are some that have fully implemented a compliant solution and are shifting from a ‘must’ to an ‘opportunity’ mindset.

It is essential that all businesses move to this mindset and view serialisation not as a regulatory burden, but as a major milestone in the development of the pharmaceutical industry, loaded with inherent potential.

Serialisation challenges and opportunities for MAHs and CDMOs

One of the more immediate and promising opportunities to create additional value from serialisation comes in the way of aggregation. IBI had already implemented aggregation for its US track-and-trace customers, so it was more a practical decision to continue aggregating product for the EU.

Implementing aggregation in parallel with serialisation will offer pharma businesses better insights into their entire supply chains as well as a host of practical benefits.

One such advantage can be seen in the advent of recalls and batch reworkings; aggregation allows the custodian of a batch to identify what is in an entire shipment by scanning one code rather than opening cases and scanning cartons one-by-one to find recalled batches.

This ability to scan a singular code to identify an entire shipment also makes the exchange of products through the supply chain significantly more efficient.

Although aggregation offers immediate and tangible benefits, it is likely that the promises of Industry 4.0 will be more revolutionary. Industry 4.0 encompasses the latest wave of technological advances, tools and processes that will drive the next phase of pharmaceutical manufacturing to improve quality, reliability and efficiency.

It means enabling smart, decentralised production, with digitised factories, integrated IT systems and flexible, highly integrated manufacturing systems.

Integration and digitisation, when it comes to Industry 4.0 are key, and both are inherent to serialisation.

Capital investment in new integrated technology on production lines, vertical integration of data, horizontal integration with supply chain partners, collaboration with external companies to improve systems are all requisite elements of a compliant serialisation solution.

They are also the foundations of Industry 4.0; the data being generated, transferred and recorded as part of serialisation will later be interpreted and used to drive improvements throughout the supply chain.

Finally, some businesses have leveraged network-tenant platform connectivity and created a unified master data approach as part of their serialisation project.

Although these have not been mandated by the EU FMD, they are the next step in improving the quality and safety of drug products as they predicate higher standards of data quality and more effective communication between partners throughout the supply chain.

Final thought

Companies operating in the EU pharmaceutical sector will no doubt be focused on FMD compliance for the foreseeable future, and there are several big challenges to overcome that will be taking up their attention.

What must be advocated however are software solutions that not only allow compliance but bring with them the ability to progress value-based initiatives from serialisation that will ultimately create a safer, more secure and efficient pharmaceutical supply chain.

Luca Pezzano will be speaking at FutureLink Munich, which will take place on 6–7 June. Designed for both commercial and operational executives from the pharmaceutical and healthcare industries, FutureLink will deliver content through two separate tracks customised for executives with interests in regulatory compliance or commercial initiatives.

The full GDSST report is also available for download here.