Kate Coleman - VP of Quality and Compliance, Arriello
The pharma industry continues to be in a state of flux. Merger and acquisition activity remains rife, new regulatory updates are being rolled out all the time, and companies are still reviewing supply chain security following the pandemic, the ongoing situation in Ukraine, and economic uncertainty.
Meanwhile, a whole raft of patents are expiring, triggering a rise in biosimilar manufacture. As new molecules pass through the pre-clinical stage and move toward clinical trials, developers must consider formal requirements including quality GxP measures as part of their clinical strategies.
As 2024 gets underway Arriello’s Kate Coleman assesses the multiple priorities vying for attention.
1. Regulatory Updates: ICH Q9 Quality Risk Management
Regulatory updates have been coming thick and fast in Life Sciences in recent years, in step with the accelerating pace of change in the industry. One of the most notable changes for drug manufacturers in 2023 has been the updated ICH Q9 guidance on quality risk management. This provides important new impetus around the development of robust, fit-for-purpose quality risk management plans - in other words, those that positively position companies to spot and mitigate issues in advance.
Although many companies consider themselves to have good quality risk management programs in place already, because they are performing a lot of risk assessments, this perspective is too reactive, and compliance driven. The real question is whether existing measures are really working for the organization, in making it possible to anticipate and mitigate risks in advance. Are teams seeing a reduction in the amount of process-related/quality-related deviations, for instance; are recalls/product issues/customer complaints reducing? If the outcomes aren’t improving year on year, then strategically the quality risk management program needs some work.
The point of the updated guidance is to remind manufacturers of the purpose of quality risk management so that they embed risk-based decision-making into everything they do.
2. Supply Chain Security
Although the COVID-19 pandemic is now largely behind us, there is no room for complacency. Added to the impact of this and other future global health events on the need for ready access to vaccines and medicines, the disruption caused by wars in Ukraine and now Israel, as well as growing economic uncertainty, provide a further reminder of how fragile supply can become where key sources are remote and there aren’t adequate contingencies.
The sourcing of active pharma ingredients (APIs) represents a particular point of risk for medicinal product manufacturers. In the case of Advanced Therapy Medicinal Products (ATMPs) including cell, gene, tissue-engineered, and somatic-cell therapy medicines, excipients (non-active ingredients) and other raw materials might be unusual and single-sourced from a far-flung country, yet essential to manufacture.
To avoid supply chain-based risks, where an individual manufacturer’s demand is only in very small volumes/of low overall value, it may be necessary for manufacturers to join forces to shore up their supply routes if they can find a way to do this without compromising their intellectual property. Banding together to boost combined demand could help build the business case for alternative suppliers to enter the market, for instance.
Ultimately, as blockbuster drugs give way to more targeted and complex therapies, companies (especially newer ones) need to be realistic about where they sit in the food chain: they can’t rely on enthusiasm alone to ensure they can get the product out to the market, especially where they don’t have the economic power to shore up supply.
Looking at existing measures as objectively as possible will help pinpoint any risks, which can then inform a new strategy. Other options might include manufacturing excipients internally or partnering with suppliers and providing them with incentives to fulfill their wider requirements.
An important consideration in boosting internal production is the time, cost, and skills commitment of establishing a new GMP-compliant manufacturing facility. From fulfilling the latest regulatory criteria to ensuring the new facility is bespoke to the current need (and has the scope to grow in future), to attracting the right scientific experts, the investment involved is likely to be considerable. 3.
3. Sustainability
Environmental, social, and corporate governance (ESG) is high on the agenda for most industries today. However, the biologics industry has a mixed relationship with environmental sustainability, given the need for low bioburden or sterile manufacturing which currently favors the use of single-use consumables from a patient safety perspective.
Yet pharma does need to address its consumption of single-use plastics, broadening its focus from patient safety in a vacuum to including wider protection for the environment, with a consistent end-to-end strategy that leaves no room for accusations of greenwashing. Although patient safety will always be paramount, which inevitably influences contamination control throughout manufacture, transportation, and storage, there needs to be a balance – so that measures that are keeping patients safe are not contaminating entire communities.
4. Planning Quality into the Fuller Product Lifecycle
As patents on a whole raft of established drugs expire, we continue to see a rise in the manufacture of biosimilars. As new molecules pass through the pre-clinical stage, into clinical trials and beyond, developers must consider formal requirements including quality and GxP measures as part of their clinical and then commercial strategies.
For companies to position themselves as major shareholders in new markets, they need to design quality into their processes upfront. Understanding how they would ideally commercialize the finished product, and keep quality considerations aligned throughout, can be pivotal in getting to market faster, for instance through the right partnerships, e.g., with Marketing authorization holders, license holders, and organizations providing strategy and scientific advice.
Considerations here might include partnering with a contract manufacturing organization (CMO) that has both the clinical and also the commercial capacity, so that when it comes to marketing authorization no significant changes will be required to their manufacturing process (which can introduce issues such as comparability and stability considerations).
5. The Pharma/Quality Skills Crisis: Building Future Teams
The global skills crisis is as evident in Life Sciences as in so many other markets, and it is incumbent on the industry, as well as on education institutions, to be proactive in addressing the growing gaps in both capability and career mindset among upcoming generations of teams, particularly those in scientific disciplines such as microbiology.
Younger team members, who have grown up in the ‘gig economy’ have more of an expectation that they will move around to gain a broad spectrum of experience, and this can pose problems where skills, experience and staying power are key to maintaining consistently high standards in quality and risk management. This means seeing through difficult projects so that they recognize and can pre-empt future issues, for instance. In cell therapy, for example, products by definition can’t be sterilized, so it is vital that nothing can get into a product while it’s being manufactured. The people who specialize in ensuring this are the microbiologist the sterility assurance specialist and the biotech personnel – yet those experts are in short supply.
Rather than continuing to push up salary expectations, the industry needs to work with education establishments to encourage a greater understanding of this industry and the exciting opportunities it presents, so we can attract not just keen scientists but also lateral thinkers, people who can connect the dots across different functions, rather than just concentrating on one thing.
This industry is crying out for people who are actually genuinely interested and curious in how modern pharma works; in how people get therapies; and how they’re developed and manufactured. There’s a perception about Big Pharma, that it’s all bad, and we need to address that head-on.
AI and the Role of a Robust Roadmap
Finally, linked to the theme of education and with a glimpse into the near future, the whole emergence of AI will be a major area to watch going forward. But this needs to start with spending time educating people about what AI really is, and its potential in the product development space. That could be in predictive chemical modeling for chemical reactions so that teams can more precisely pinpoint the experiments that may be needed for formulation or drug development. The real potential will come from thinking about the information we have, making sure this is well organized, reliable, and secure, and then using AI in combination with this verified and validated data to help streamline choices, reduce risk and waste, and thereby focus on the right things.
Developing a roadmap for all of this starts with quality risk management and risk management in general, as the discipline that knits everything together.
Author Biography
Kate Coleman is VP of Quality and Compliance at Arriello. She has over 20 years of experience in Quality Assurance, Sterility Assurance, and Microbiology Quality Control, and has worked across ATMPs, Biologics, Sterile Fill Finish, Vaccines, APIs, and Oral Dose platforms.
Over her career to date, Kate has served as a practicing QP, Principal Consultant, and qualified Lead Auditor. She is also a subject matter expert in Risk Management, New Facility Design/Start-up, Quality Control and Sterility Assurance. In her previous role before joining Arriello, she was Senior Director for Quality Management and Compliance and Head of QMC.
Kate is particularly passionate about the interdependence of Regulatory and Quality, as companies develop their strategies and processes and look more holistically at what they need, rather than operating in silos.
[email protected], www.arriello.com
Publication Detail
This article appeared in American Pharmaceutical Review:Vol. 27, No. 1Jan/FebPages: 38-40
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