Editorial | Open Access | Published 18th December 2025 

GUEST EDITORIAL: Our Industry is Evolving

Author: Chris Morgan - ATMP Solutions Ltd

Our industry is evolving.

Medicines are being developed for diseases that were previously untreatable, and new technologies such as cell and gene therapies, gene editing (ATMPs), Antibody Drug Conjugates (ADCs), and Lipid Nano Particles (LNPs) are providing new ways to target these diseases.

Importantly, rather than just treating disease symptoms, some of these new medicines have the potential to be curative.

To provide these benefits, medicines, their delivery mechanisms, and the supply chains associated with their manufacture and distribution are becoming more complex and with that complexity comes risk and, of course, cost.

The pace of change is remarkable, but this brings new challenges, including a shortage of skills and expertise.

What is the point of creating a medicinal product if it can’t be given to a patient because storage conditions make it prohibitive to ship, or it’s too expensive, ruling out supply to vast swathes of the population?

These issues were highlighted by the global pandemic when vaccine supply logistics were hampered by the need for cold storage, and vaccines were not available to poorer nations.

A lot of investment and research is going into making medicines more stable (to not need controlled temperature conditions) or to re-imagine supply chains so that stability is negated because ‘fresh’ products are manufactured and administered locally.

Decentralised Manufacturing – making products locally to the patient offers significant potential benefits:

• Easier chain of custody (fewer opportunities for error or intervention to medicines)

• Greater flexibility and access for patients (scheduling and preparation)

• Simplified medicines distribution – fewer opportunities for excursions during storage

• Easier to manage the process ‘vein to vein’

However, the trade-off is a far more complicated process-management task to ensure the quality and thus the safety of medicines manufactured in this way.

The UK’s Medicines and Healthcare Regulatory Agency has been a global leader and has issued regulations that enable Decentralised Manufacturing, as showcased by Ian Rees at the PHSS Sterile Product Manufacture conference held in June 2025.

On the whole, the pharmaceutical industry isn’t sure how to adopt Decentralised Manufacturing and overcome the complexities associated with it, in part due to the aforementioned skills gap.

The quality of medicinal products is paramount, and to this end, there is a raft of regulations that mandate and enable patient safety to be assured.

In order to market a medicine, it needs to be licenced.

This requires businesses to demonstrate:

1. How the product has been designed to fulfil the clinical needs, how the manufacturing process has been developed to provide the medicine consistently and how facilities, utilities and equipment have been designed to enable and protect the manufacturing process (the requirement to demonstrate Quality by Design).

2. What checks and balances are in place during the manufacturing process to confirm that everything is working correctly and as per the registered details (Chemistry and Manufacturing Controls), such that the medicinal product matches the stated characteristics (Critical Quality Attributes).

To this end, Quality Risk Management is employed to identify critical aspects associated with the creation, storage and distribution of medicinal products. Critical aspects must be defined such that processes can be properly designed with suitable control measures and monitoring strategies to assure the quality of every dose through to the point of administration to a patient.

These controls must be built into an organisation’s Pharmaceutical Quality System (PQS) and are fundamental to the Quality Assurance needed to demonstrate that each dose of a medicine is safe and efficacious.

Traditionally, the easiest way to manage the PQS burden has been to centralise manufacturing efforts for tighter control and oversight, and then distribute products as necessary to treatment centres and bring the patient to the centre.

Decentralised Manufacturing will require the PQS to be applied remotely to demonstrate sufficient assurance of the necessary controls at each manufacturing site.

To have a robust PQS and apply it universally across multiple disparate sites (this could include hospitals or a patient’s home or a mobile unit) requires a degree of maturity and enough flexibility for the system to be agile enough to cope with the challenges without placing additional risk that ‘events’ are not identified and suitably addressed (one of several concerns raised by Rebecca Rutter in her presentation to PHSS QP Forum conference in October 2025).

The pharmaceutical industry is transitioning through ‘Pharma 4.0’ – digitalisation / automation of manufacturing processes (requiring standardisation and enabling guard rails to be built in for error proofing).

A good example of this would be an integrated manufacturing facility utilising electronic batch records such that a manufacturing step could not proceed unless it had been completed correctly (equipment calibrated and qualified for use, operator trained in the task, materials scanned and confirmed against recipe, dispensed amount confirmed by balance feedback to digital recipe with operator sign off for attributability of data).

It is relatively easy to design and maintain this type of process centrally, and many organisations have. It is more complicated to do this globally and requires significant organisational discipline to be able to create and, more importantly, maintain a degree of functional equivalence across multiple ‘centralised’ sites.

Decentralised Manufacturing takes this a step further, potentially requiring calibration, qualification and functional equivalence of mobile equipment, confirmation of operator training, management of raw materials, product and samples at a number of disparate locations requiring far more assurances to be built into the operation, but the principles are no different.

This is happening in a backdrop of continuous improvements to regulations (for example EudraLex Volume 4 recent Annex 1 update, current revisions to Chapter 1, Chapter 4, Annex 11 and introduction of Annex 22) and at the dawn of ‘Pharma 5.0’ - sustainable, personalised medicines achieved through automation and integration of Artificial Intelligence with humans looped in to make necessary decisions.

The pharmaceutical industry is notoriously slow to adapt and innovate. In this era of rapid change, it is hard to find the expertise required to design the medicines of tomorrow and the processes, facilities, utilities and equipment required to manufacture them, but this will not be resolved by looking back at what was successful in the past. We need to embrace the changes that have led us to where we are today and be looking forward at what we need to do to get where we need to be.

Academics are giving us new tools and techniques, the regulators are providing frameworks and guidance, and we, as medicine makers, need to step up with the knowledge to create the infrastructure required to manufacture the medicines that offer such promise to all those that need them. This will come through collaboration and organisations such as PHSS, ISPE, Biophorum, CCN provide many opportunities for us to come together, share experiences and identify common themes, be they issues or resolutions. It’s up to us to take this shared learning back to our organisations in readiness for what’s to come.