Contract manufacturing: Digitisation to the front

Some of the leading figures in the contract pharmaceutical industry discuss digitisation and its increasing uptake throughout the sector

Following the roundtable that saw leading figures in the contract pharmaceutical industry talk about cyber security and industry hurdles, the panellists now addresss other areas of innovation, new technologies being explored, and how they can be used to find new and better ways of working.

Dexter Tjoa, Director Corporate Strategy, Tjoapack, jumps right in. “As previously mentioned, blockchain is becoming more widely used in the pharmaceutical industry to prevent counterfeit medicines entering the supply chain. The result of this will be a safer and more secure supply chain with more collaborative and transparent communications between partners."

Tjoa adds: “Packaging firms are also starting to adopt processes such as postponement packaging or late-stage customisation, whereby a product is kept in a standard format until market demand arises. This allows CPOs and packaging firms to react quickly to demand and can prevent costly repackaging if a product has been prepared for a specific market and is then no longer needed."

Veratrak CEO, Jason Lacombe, comments: “There are many innovative industry-focused tools being developed that facilitate collaboration and communication throughout the supply chain and within internal departments in larger organisations, which are improving relationships throughout the industry."

"In a serialised pharma supply chain, a notable use case is new technologies that aim to create secure channels of communication and facilitate collaboration around artwork, version control and management. By enabling access to a single master file, design, packing, shipment and quality control (QC) processes can all be streamlined.”

Vincent Dunne, CEO, Wasdell Group, notes that we now have the ability to use data to drive and predict better outcomes, whether it’s on the factory floor or how products perform during a given period of time. “It’s fascinating to hear people foretelling that the use of AI will fundamentally change the way clinical trials are performed; how this will look, however, is still to be determined,” he says.

“One of the key areas we’re exploring is the use of technology to enable better speed to market, as demand can be gathered or sensed from mobile or wearable devices and bypass traditional supply chain nodes. Contract organisations such as ours are seeing the increased need to support our customers’ operations by providing processes and activities that were traditionally managed in-house, such as fulfilment, demand and inventory management. Digitising these processes and making them more efficient by default is a key competitive advantage in the market.”

TraceLink’s Senior Vice President of Engineering, John Hogan, has identified a number of trends, including the loss of patents, mergers and acquisitions, growth in generics and a shift in the development pipeline to personalised and specialty medicines that are heightening demand for more streamlined, integrated and responsive end-to-end supply chains. “Many of these trends are increasing supply chain complexity, disrupting traditional business models and putting pressure on responsiveness and margins,” he notes.

“The pharmaceutical industry is evolving in response — but there is a much stronger need for specific knowledge regarding how these therapies and medicines travel full circle through the supply chain. Aspects such as logistics and temperature control are critical, as these drugs are life-saving and expensive, leaving absolutely no room for error. The industry needs to adapt to seamless information exchange between supply chain partners … and you need a digital network platform for this to happen,” he explains.

“CDMOs are expanding their capabilities to meet demand from pharma manufacturers who are looking to focus on their core capabilities and outsource to experts,” says Mark Muldowney, Head of Technology and Innovation at Sterling, adding: “Many European CDMOs are also looking to acquire facilities in the North American market to strengthen their offering in the region.”

“Specialist expertise is an area in which CDMOs can offer significant value to clients, so this is something driving innovation and new technology in the sector. We’ve noticed particular interest in areas such as hazardous chemistry, which Sterling specialises in."

"We are continuing to use hazard evaluation and our expertise in hazardous chemistry to explore alternative and more direct routes to market, enabling customers to reduce costs, improve safety and curtail turnaround times,” he continues, concluding: “It is important to note that companies have been manufacturing APIs for decades, so most of them are unlikely to be improved significantly using new tech. Instead, the focus should be to find solutions to key problems in the industry, such as how to handle certain hazardous chemicals more safely.”

“There are many factors involved in a changing landscape, such as the potency of active ingredients, continuous challenges from cross-contamination in multiuse facilities, validation in sterile production, a more fragmented supply chain with the rise of the CMO and increased market competition, to name a few,” contributes Ben Wylie, Senior Product Manager, ChargePoint. “Ultimately the market needs more standardised, flexible, validated and ready-to-go solutions that generally point in the direction of single-use technologies.”

“However,” he says, “these technologies cannot compromise on performance; rather, they will need to evolve to improve the status quo as opposed to just being a cheaper alternative, which is the biggest challenge. Companies throughout the industry will need to come together to co-ordinate common solutions rather than just do things their own way.”

“For example, the increasing demand for oncological and immune-suppressant therapies is driving the growth of HPAPI use in drug manufacturing. This trend has significant implications for the entire pharma supply chain. Meeting the increasing pressures that exist in a highly potent production environment can be a challenge. As a result, manufacturers are increasingly looking for innovative containment strategies to meet the stringent requirements associated with high potency handling.”

“Furthermore,” he continues, “with more pharmaceutical companies than ever utilising multiple manufacturing locations, the development, manufacture or packaging of products is often wholly outsourced. Now, 100% of manufacturing can be performed by third-party CMOs if needed. Consequently, more drug products are being moved between facilities, which increasingly involves transportation between countries, globally, from drug supply sites to drug product formulation locations.”

Multisite solutions mean that users can take advantage of the benefits of disposable technology (without compromising performance) by changing the dynamics of the value chain when handling ingredients within and between facilities.

It provides a method of contained powder transfer within facility A (drug supply) and can also be used as a product’s primary packaging and container closure for transportation to facility B (drug product formulation).

As such, it provides CMOs and in-house manufacturers with the ability to handle ingredients with less risk by eliminating the double handling concern, even though this will nevertheless still need to go through a lot of qualification and monitoring between associated sites to ensure quality.

Product sampling without breaching the delivered and dispensed package is a challenge that requires innovative techniques such as NIR. And, although this technology has been used for some time, it’s not commonly utilised to sample product received from other sites.

Notes Ben: “The standardisation of solutions such as these means that they’re available off the shelf and ready to use, which enables pharmaceutical companies to deploy a prequalified system without significant delay. It’s a must have for the increasingly fast paced, flexible and cost-conscious nature of today’s pharmaceutical supply and manufacturing network.”

“Equally,” he concludes, “the recent surge in pharma companies deploying artificial intelligence (AI) capabilities in pharmaceutical R&D shows no sign of slowing. Pharma companies are investing significantly in streamlining or accelerating applications using AI methods to identify new targets and medicines."

"Yes, it’s still currently unknown whether AI will meet industry expectations, but the potential exists for significant increases in the rate that new drugs enter the market. This could result in greater demands on manufacturing within the pharma industry. Likewise, the question remains regarding how AI — or even VR — can be applied to the manufacturing environment to increase operational efficiencies.”

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Sterling Pharma Solutions (more information, website)

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