As we head into 2024, we can expect a continued focus on bringing more personalised medicines to patients, notes Ben, Head of Product Management at ChargePoint Technology.
Personalised therapies, such as advanced therapy medicinal products (ATMPs), are typically manufactured in smaller batches for Phase II and III clinical trials.
This will necessitate a shift towards manufacturing smaller batches as opposed to large-scale production. The doses manufactured for these therapies are unique to each patient, meaning that the machinery used must be able to swiftly adapt to new batch requirements without compromising quality.
Consequently, manufacturers working with these highly personalised therapies are actively seeking manufacturing, handling and transfer solutions that help to facilitate a seamless transition between batches.
These solutions must also ensure that optimal containment is maintained at every stage and that sterile integrity remains uncompromised.
Keeping up with the heightened demand for this level of adaptability has led to an uptick in the use of single-use technology (SUT) products across the industry.
These solutions can be disposed of after each batch, eliminating the need for time-intensive cleaning and validation processes and therefore streamlining production for manufacturers.
SUT products are also highly adaptable to the unique requirements of personalised therapies. They typically have shorter sourcing lead times and demand less investment than their stainless-steel equivalents, which are particularly important considerations during the clinical stages of manufacture.
As a result, we can expect demand for SUT as an integral manufacturing component to increase as the personalised medicines market continues to grow in 2024.
A digitised future
The convergence of information technology (IT) and operational technology (OT), says Trevor, Senior Director, Head of Consulting, Cognizant Life Science Manufacturing, combined with the growing use of artificial intelligence (AI), is transforming pharmaceutical operations and how companies make medicine.
This will continue into 2024, with converging technologies enabling the move towards automated systems and streamlined data storage and analysis; this will provide cross-site and system insights for better-informed decision making with augmented intelligence.
AI is already making a significant impact on the way medicines are discovered, launched and made by enabling the super-fast processing of vast amounts of data.
Instead of synthesising approximately 1000 molecules a year, companies can process 50 billion molecules, resulting in a total game changer for drug discovery.
In addition, we are seeing pharma companies utilise generative AI to create a culture of helpfulness by building wise assistants that can work on certain tasks; but, it’s traditional AI that’s transforming the industry right now.
Traditional paper-based record-keeping continues to be phased out in favour of cloud-based digital execution systems.
These new software applications and automation tools, such as low/no-code capabilities, are streamlining operations, extracting richer data insights and driving clients closer to their digital transformation goals.