Regulatory & Quality Trends for 2024

Source: European Pharmaceutical manufacturers

ICH Q9 Quality Risk Management: the regulatory response

One of the most notable changes for drug manufacturers in 2023 has been the updated ICH Q9 guidance on quality risk management, prompting companies to review quality risk management plans to ensure that they are fit for purpose (i.e. that they position companies to mitigate issues pre-emptively rather than reactively).

While most companies routinely perform risk assessments, the approach has been largely compliance driven up to now. To challenge their value, companies need to review whether teams are seeing a reduction in the amount of process-related/quality-related deviations, for instance, or to what extent recalls/product issues/customer complaints are coming down. If the outcomes aren’t improving year on year, then strategically the quality risk management programme needs some work.

Shoring up Supply Chains

The residual impact of the pandemic and the prospect of other future global health events on the need for ready access to vaccines and medicines, as well as disruption caused by wars in Ukraine and now Israel, and growing economic uncertainty, highlight how fragile supply can become where key sources are remote and contingencies are insufficient.

To avoid supply chain-based risks, especially in specialist manufacture where an individual company’s demand is only in very small volumes/of low overall value, it may be necessary for drug producers to join forces to shore up their supply routes – assuming they can find a way to do this without compromising their intellectual property. Combined demand could help build the business case for alternative suppliers to enter the market, for instance.

Reviewing existing measures as objectively as possible will help pinpoint any risks, which can then inform a new strategy. New options might include manufacturing excipients internally or partnering with suppliers and providing them with incentives to fulfil their wider requirements. The costs and time required to establish a new GMP-compliant manufacturing facility and attract the right scientific experts could make in-house production prohibitive, however.

ESG

Environmental, social and corporate governance (ESG) is high on the agenda for most industries today, but the biologics industry has a mixed relationship with environmental sustainability. This is because of the need for low bioburden or sterile manufacturing, which currently favours the use of single-use consumables from a patient safety perspective. 

Although patient safety will always be paramount, which inevitably influences contamination control throughout transportation and storage, to reduce the impact of single plastic over-consumption on local communities.

End-to-end quality planning

The rise in biosimilar manufacture, as patents on established drugs continue to expire, brings with it formal requirements including quality and GxP measures as part of producers’ clinical and commercial strategies for new molecules.

For companies to position themselves as major shareholders in new markets, they need to design quality into their processes up front. Understanding how they would ideally commercialise 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 Authorisation Holders,  licence holders, and organisations providing strategy and scientific advice.

Considerations here might include partnering with a contract manufacturing organisation (CMO) that has both the clinical and also the commercial capacity, so that when it comes to marketing authorisation no significant changes will be required to their manufacturing process (which can introduce issues such as comparability and stability considerations).

Cultivating future capabilities

The global skills crisis is as evident in Life Sciences as in so many other markets, and it is down to the industry, and to education institutions, to proactively address the growing gaps in both capability and career mindset among upcoming generations of teams, particularly those in scientific disciplines such as microbiology.

Professionals 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, for instance. Where skills, experience and staying power are key to maintaining consistently high standards in quality and risk management, a “move on” mindset can pose problems. Mature skills come from seeing through difficult projects so that team members are able to recognise and preempt future issues. In cell therapy, for example, products by definition can’t be sterilised, so it is vital that nothing can get into a product while it is being manufactured. The people who specialise in ensuring this are microbiologists, sterility assurance and biotech personnel. Yet those experts are in short supply currently.  

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 that 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. The solution starts with addressing the perception that Big Pharma is bad.

A word on AI

Connected to the theme of education, and with a glimpse into the near future, the whole emergence of AI will be an increasingly important field to watch, and any progress must begin with pinpointing the technology’s potential in the product development space.

That could be in predictive chemical modelling for chemical reactions, so that teams can more precisely pinpoint the experiments that may be needed for formulation of drug development, for instance.

The real potential will come from thinking about the information that already exists, making sure this is well organised, reliable and secure, and then using AI in combination with this verified and validated data to help streamline choices, reduce risk and waste, and so focus on the right things.

Developing a strategic roadmap for 2024 and beyond begins with quality risk management, and risk management in general, as the discipline that underpins all of these emerging and converging trends.