Contract manufacturing: Innovations in a digital age

Some of the market’s leading figures explain why the uptake of digitisation gives pharmaceutical companies an edge over competitors

Digitisation of the pharmaceutical supply chain is gaining increasing prominence across the industry. Manufacturing Chemist asks some of the market’s leading figures in the industry how viable they think end-to-end digitisation is and what benefits could it offer? This roundtable comprises the views of representatives from Tjoapack, Veratrak, Wasdell Group, TraceLink, Sterling, and ChargePoint.

Dexter Tjoa, Director of Corporate Strategy at Tjoapack, believes that end-to-end digitisation, although viable, relies on a high level of commitment from all players in the supply chain. “Those companies looking to digitise their processes may have to completely overhaul their existing systems to do so,” he says, “which is a costly and resource-intensive venture. In addition, the silos within the chain would need to be broken down to ensure better communication between partners," he says.

Dexter Tjoa, Director of Corporate Strategy, Tjoapack

Tjoa points out that companies throughout the pharmaceutical industry are starting to implement digitisation because it offers better visibility of their value streams, allowing them to make more informed commercial decisions. "Additionally, this increased visibility enables organisations to react more efficiently to market demand; as a result, the patient benefits from a faster and more robust supply chain,” he adds.

Jason Lacombe, CEO, Veratrak, says: With notable serialisation regulations in key markets now implemented, there is a new opportunity to push for digitisation and to create value-added capabilities in areas adjacent to serialised products, such as the digitisation and traceability of quality documentation.”

Cyber security

Batch records and artwork are of the utmost importance and yet a significant portion of the industry is still sharing this information via email — one of the most unsecure data transfer tools in the world.

Jason Lacombe, CEO, Veratrak

Lacombe advises: “As an industry, we can improve when it comes to the process of sharing critical documentation. Moving companies from outmoded information sharing practices is a key aspect of breaking down silos in the supply chain and enabling end-to-end visibility. Better visibility of data, documents and the provenance of medications will facilitate greater collaboration between players throughout the supply chain in ways that have not been possible before."

Wasdell Group’s CEO, Vincent Dunne, notes that the evolution of digitisation has been progressing for some time and observes that the pace of change during the last two to three years has become increasingly rapid. “Within manufacturing, it is now common practice to use concepts that were seen as innovative just a few years ago, including machine learning, 3D printing and anti-counterfeiting technologies such as serialisation,” he says.

Vincent Dunne, CEO, Wasdell Group

Dunne points out that beyond the factory floor, the use of artificial intelligence (AI) is increasing as well as demand sensing replacing traditional forecasting techniques, and blockchain being used to deliver greater visibility and compliance. "Fundamentally, digitisation is enabling increased agility, lower costs and greater compliance, and Wasdell is working on many of these applications with customers, particularly regarding the supply of medicinal products," he says/

John Hogan, Senior Vice President of Engineering at TraceLink, concurs. He says companies around the world are looking to digitally transform their supply chain capabilities, holistically improve business performance and, at the same time, become more customer-centric, partnership-oriented and industry minded. Hogan believes that transformation comes the need for technology to scale-up in parallel. “Cloud-based network applications have really opened up opportunities for collaboration because they provide a very simple way for people to communicate with each other on a many-to-many basis,” he says.

For Hogan, serialisation capabilities have created opportunities for further collaboration in the pharmaceutical industry, and information sharing in a safe and secure way to solve some of the critical business challenges that the industry has been facing for years. "These opportunities can become a reality via a digital network platform that enables next-generation technologies to be built, fuelling a healthcare ecosystem that enables end-to-end visibility from ingredient to patient and allowing the industry to work together in entirely new ways," he explains.

John Hogan, Senior Vice President of Engineering, TraceLink

Hogan believes there is enormous value to be had in breaking down existing data silos in the industry and being able to connect and exchange information on one network platform. "This is already starting to take shape. In the coming years, all segments of the supply chain will be able to leverage these advanced technologies to increase efficiency, transparency and safety,” he says.

Hurdles to overcome

Discussing the main barriers to entry when it comes to adopting new technologies, Dexter Tjoa appreciates that the implementation of new technologies in the pharmaceutical sector is often a challenge. “The advantages of new technology are often overshadowed by the complexity of implementation, which results in a lack of buy-in from decision-makers … despite the longer-term benefits,” he says.

New technologies also suffer from a lack of education in the industry. For example, blockchain is more widely known for its association with cryptocurrencies, but it can also benefit the supply chain by providing an immutable ledger of data that, in turn, can help to secure and trace transactions throughout the supply chain.

“Although the technology is starting to be implemented on a wider scale, many pharmaceutical companies are only just beginning to consider the benefits that blockchain can offer,” Dexter adds.

Lacombe notes that scoping new technologies and vendors, investment, implementation, process changes and user training are all seen as resource-intensive issues that are potentially disruptive and invariably present significant hurdles unless there is a strong business case for adopting new technologies.

Expertise in change management is also key, as is linking new technologies to an organisation’s strategic objectives

“In response,” he says, “tech developers are concentrating on delivering solutions that offer seamless onboarding, comprehensive support services and quicker, more effective training programmes. Perhaps the strongest case for breaking down these barriers is the potential of a supply chain in which silos are non-existent and collaboration between suppliers/partners is the norm. A transparent supply chain will revolutionise the way businesses operate and offer huge value!”

Dunne concurs, and notes that traditionally, cost and time to implement were the main barriers to the adoption of new technologies and processes; but, lately what’s hampering companies is a lack of knowledge about the inherent benefits and slow decision making “Expertise in change management is also key, as is linking new technologies to an organisation’s strategic objectives. Without these in place, it’s very difficult to justify and implement digital technologies,” he says.

“Hogan reminds us that the underlying challenge is that pharma companies have traditionally been slow to adapt and, having spent many years dealing with heavy regulatory control, are risk-averse. "Often innovation and progress has been stymied as a result," he says.

Hogan also points out that to deliver transformative change, "leaders will need to reimagine what a supply chain is, change the mental model from being supply focused to patient-focused and be active participants on a digitally enabled network platform to improve capabilities and performance”.

Commenting on this challenges, Mark Muldowney, Head of Technology and Innovation at Sterling, says: “Often, process complexity, a lack of in-house experience and the industry’s regulatory landscape are the stumbling blocks for companies looking to adopt new technologies. For example, in the case of continuous flow processing, the technology is becoming more widely used within the industry."

Mark Muldowney, Head of Technology and Innovation, Sterling

"However, the limited experience regarding how best to apply current guidelines — on the part of both regulators and manufacturers — often results in manufacturers being hesitant to commit time and resources to the implementation.”

Muldowney knows that the equipment needed to implement these technologies often requires considerable investment and that scale-up requirements also have to be taken into consideration. "The capex and resources needed to assess both process viability and implementation can consequently lead to reluctance from decision-makers when considering new technologies," he says.

On the regulatory front, Muldowney comments: "Although regulatory authorities are pushing the pharma industry to apply new and improved technologies to better supply the market, there is a lack of experience on both sides, which results in the industry and authorities openly engaging with each other to drive progress."

For Muldowney, the current methods of manufacturing active pharmaceutical ingredients (APIs) have been around for at least 100 years … so there is a significant experience in this area. "When trying to introduce new technology, the knowledge gap is a key issue. Whereas academics publish what they do and share their learnings, the same can’t be said for industry … as manufacturers are keen to keep a competitive advantage,” he concludes.

Joining the fray, Ben Wylie, Senior Product Manager, ChargePoint, observes that the pharma manufacturing industry has witnessed considerable changes during the past few decades with the introduction of many new regulatory changes and the onset of novel technologies.

Ben Wylie, Senior Product Manager, ChargePoint

“There are many matters for these pharma companies to consider when updating processes or technologies, including regulatory changes, market factors and aligning commercial strategies. However, with the growing demand for medicines that have complex manufacturing requirements, pharmaceutical companies must introduce aseptic and high potency manufacturing processes into their operations,” he says.

Effective containment during high potency manufacturing is important to protect the safety of operators, whereas aseptic processing measures must protect the drug product from contamination. Any contamination during the drug manufacturing process can have a substantial financial impact, not to mention possible implications within the supply chain.

In response, pharmaceutical manufacturing environments are constantly evolving and employing smart monitoring capabilities. This provides manufacturers with an automatic/reliable method of understanding the health status of processes and transfer devices to better control risk and ensure consistent integrity throughout the lifecycle of the system and its critical components.

“With hybrid single-use technology now being adopted in pharmaceutical manufacturing processes, 2019 is no exception,” says Wylie, adding: “Although single-use technologies need to deliver the same level of performance as some of the more traditional stainless-steel solutions, the reality is that this is often not the case. A new hybrid solution now includes disposable versions of split butterfly valve (SBV) technology, which enable the contained and sterile transfer of pharmaceutical powders.”

For Wylie, users need to be convinced that such technology will provide the same level of performance as reusable technology in the short duration that it’s used. "This needs to be provided in the form of performance test data … but the end-user is generally reluctant to be the ‘first to try’ and prefers to have an established technology that others have already trialled," he explains.

He continues: “Responding to the challenges of today and tomorrow, pharmaceutical manufacturers also need solutions that are prevalidated, ready to use and deliver repeatable and reliable performance levels. They must also be easily integrated into existing processes and perform to the highest level of containment and sterility assurance."

Wylie points out that hybrid single-use SBV systems are lightweight and cost-effective, and explains that these are designed to deliver containment and sterility assurance performance while eliminating the time and cost associated with cleaning, maintenance and validation of the disposable half, something that will increase productivity and reduce downtime.

To summarise, with all of the above, it’s not uncommon for pharma companies to sit tight and wait until the early adopters have taken the lead in innovation before they dip their toe into adopting new technologies.

Featured Companies

Sterling Pharma Solutions (more information, website)

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