Future innovations in pharmaceutical contract manufacturing

In the final part of our roundtable, panellists look at current drivers and assess the long-term interest in on-trend topics such as digitisation

Dexter Tjoa, Director of Corporate Strategy at Tjoapack suggests that more complex NCEs (new chemical entities) are entering the drug pipeline owing to the rise in personalised medicines and targeted therapies.

“These products are often aimed at smaller patient populations and have smaller batch requirements,” he says, adding: “It’s likely that demand will continue to grow for personalised medicines, and companies will be required to adapt and cater to a market wherein smaller, high-value batches are the norm. In this environment, postponement packaging can prevent overages, leading to less waste and will enable firms to supply patients with greater efficiency patients.”

Jason Lacombe, CEO, Veratrak, adds: “Industry’s adoption of cloud and SaaS products will become pivotal … and we will see new business models for collaboration between suppliers and their customers start to emerge. As the sector continues to outsource more of its niche requirements to different industry partners and third-party suppliers, the need for better end-to-end visibility and auditability will become paramount."

"The pharma market is highly competitive, and businesses are constantly looking for every advantage they can find. Currently, there is a digitisation race as the move from paper to e-platform will deliver significant efficiency gains.”

Vincent Dunne, CEO, Wasdell Group, agrees, stating: “There are multiple drivers here, from the increased need for speed to bring new products to market and to drive growth by reacting quicker to market dynamics. Regulatory interests and environmental requirements are also key."

"We don’t need to look much further than the US FDA’s Health Innovation Action Plan and the European Commission’s smart wearables paper for evidence that regulators have a vested interest in introducing digital technology whenever possible in the pharma supply chain.”

The supply chain management market is on pace to exceed US$19 billion by 2021.1 This is being driven in part by the huge amounts of data collected as the supply chain becomes more integrated. Within the pharma supply chain, for example, TraceLink processes hundreds of millions of serialisation events on its ecosystem of more than 275,000 members from across the supply chain.

“The growth also stems from business incorporating new technologies, as previously discussed. Artificial intelligence (AI) and machine learning (ML) will enable businesses to detect patterns they didn’t even know existed. AI in the supply chain is still in its early stages, but when trained, AI can help businesses to mine data lakes to answer questions, solve problems and chart the course for future success."

"With AI’s ability to optimise data analytics, businesses will soon be able to achieve full end-to-end visibility into each product’s journey through the supply chain,” notes John Hogan, Senior Vice President of Engineering at TraceLink.

“Forrester has also forecast that total spending on Internet of Things (IoT) technology is expected to increase to $435 billion by 2023.2 This increase in spending is largely driven by the track-and-trace sector, serialisation in the pharma supply chain and the ongoing digitalisation of the supply chain industry,” he adds.

“The use of IoT devices in the pharma supply chain allows companies to track products in real-time from manufacturing all the way through to final delivery, including product conditions and temperature-monitoring along the way.”

“When it comes to high-value medications such as personalised medications that are being uniquely developed for specific patients,” he continues, “this technology is critical; product quality must be perfect … and temperatures must be controlled along the way to ensure product efficacy for customers. The adoption and advancement of these technologies will continue to evolve in coming years, driven by significant investments from the entire pharmaceutical supply chain.”

Adding to the mix, Mark Muldowney, Head of Technology and Innovation at Sterling, comments: “Many developments within the pharma manufacturing industry are being driven primarily by demand. For example, the shift away from blockbuster drugs to more niche products has led to a need for improved manufacturing efficiency and quality to ensure products reach patients swiftly and safely."

"For API manufacturers, methods such as continuous flow processing can offer reduced operating costs and improved process efficiencies.”

“Additionally, CDMOs are looking to offer the right flexibility and capabilities in key emerging technologies (such as biocatalysis, hazardous chemistries, fluorination, etc.) as sponsor companies continue to look to consolidate supply chains rather than outsourcing to multiple partners."

"Firms are continuing to investigate new technologies, although industry uptake is notoriously slow. It’s likely that we will see wider industry uptake in the coming years as more and more firms look to innovate to meet growing demand and new product requirements.”

Looking ahead

In terms of exploring and implementing new technologies in the coming years, Dexter Tjoa believes that it’s likely that new technologies will be increasingly cost-effective when compared with legacy systems, and firms with more efficient processes will be able to ensure faster product turnaround times.

“Companies that adopt new technologies early will reap significant benefits in the future. They will find themselves at a competitive advantage in an industry that’s desperate for innovation and looking for digitisation to deliver it.”

Perhaps more tentatively, Jason Lacombe ponders why, in an environment wherein regulators and the pharma industry are working incredibly hard to secure the supply chain, is it acceptable to send highly sensitive documents through non-secure and non-collaborative channels such as email.

“There are countless errors whereby the wrong person is the receiver or is cc’d in an email,” he says, “but imagine a scenario in which packaging artwork files are sent to the incorrect person and fall into the hands of counterfeiters; the security of the entire supply chain is compromised in an instant. Addressing this risk should be the next big thing that regulators target with a number of serialisation laws in key markets now in effect.”

“We are also seeing a desire to move away from traditional enterprise tools that are outdated and do not provide a positive user experience. We are used to seamless user experiences in our consumer applications (Facebook, Twitter, LinkedIn), but this has not translated into industry."

"It should be the norm to offer companies and users well-designed products that facilitate collaboration and good working relationships between players throughout the entire pharma supply chain,” he adds, concluding: “Organisations need to break down silos and facilitate better communication and collaboration with their partners; new technologies are providing opportunities to deliver this while ensuring compliance."

"The life science industry’s challenges and processes are unique, so GxP-validated software providers that are developing purpose-built platforms will outperform industry agnostic software vendors in this space for years to come.”

Vincent Dunne is convinced that new technologies will continue to enable businesses to achieve strategic objectives. “In pharmaceuticals, we believe that the drive and focus on patient outcomes will force the use of new technologies and manufacturing processes. Personalised medication is no longer an aspiration, it’s a reality and is having an impact right back to the factory floor by forcing smaller batch sizes and adaptable manufacturing.”

“Overages simply aren’t an option when manufacturers are handling vials worth thousands of pounds; they can’t load up a supply chain with a year’s worth of stock and not worry about obsolescence like they have in the past. We’ve got this problem partly solved with the introduction of more agile packaging and logistics processes, such as Just in Time (JIT) labelling; however, supply forecasting and predictive analytics have to be better and quicker … and the only answer is innovative digitisation. This is where we’ll see the most investment in new technologies during the coming years,” he adds.

Pharma 4.0 (Industry 4.0) and IIoT (Industrial Internet of Things) themes offer up some interesting avenues for manufacturers to exploit technology and improve on outcomes for both themselves and patients. The use of automation is already increasing in production environments, and this trend is expected to grow rapidly as the potential for the more efficient integration of processes and Industry 4.0 are fully realised.

Says Ben Wylie, Senior Product Manager, ChargePoint: “The industry has already started to integrate wireless monitoring technology into its containment strategies, including the development of new smart monitoring technology that offers customers more data, helping them to manage the health status of their device."

"Replacing the need for manual monitoring and production downtime for equipment checks, Smart Monitoring technology provides an automatic and reliable method of understanding the health status of key components of, say, a valve. This allows operators to better control risk and ensure consistent integrity throughout the lifecycle of the system.”

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As demand for high potency drugs increases and the biotechnology sector continues to boom, manufacturers will continue to look to technological advances to drive future change in manufacturing facilities. “We expect to see more specialisation of services among CDMOs as pharmaceutical companies continue to outsource projects in which greater value can be realised by experts in dedicated niches."

"This will allow firms access to the required proficiency to move a drug from development through to scale-up and commercialisation,” says Mark Muldowney.

“For firms to access new molecules, the complexity of the chemistry used may increase. This may involve specialised or hazardous chemistry to reach the target molecule. Outsourcing this type of work to CDMOs will therefore increase as they will have access to the necessary technologies,” he continues, adding: “For example, developers can mitigate risk and reduce costs by outsourcing to specialists in hazard evaluation, which allows a process to be thoroughly investigated for risks and potential direct routes to market before scale-up.”

“In the case of continuous flow processing, manufacturers utilising this process can use dedicated equipment to access extreme conditions that were previously unattainable, and minimise the risk associated with these conditions and chemistries. In short, CDMOs are starting to combine the use of new or innovative technologies with their experience of scale-up to build processes that are robust enough to use these new technologies to their full potential,” he concludes.

References

  1. www.gartner.com/en/newsroom/press-releases/2017-06-22-gartner-says-supply-chain-management-market-will-exceed-13-billion-in-2017-up-11-percent-from-2016.
  2. www.forrester.com/report/Forrester+Analytics+InternetOfThings+Spending+Forecast+2017+To+2023+Global/-/E-RES142092.

Part II can be found here.

Part I can be found here.

Featured Companies

Sterling Pharma Solutions (more information, website)

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