The CDMO sector is one of the most rapidly evolving segments of the pharmaceutical market, driven by demand for new molecules driving increased screening of new chemical and biological entities. As many of the companies involved in these discovery projects are spinouts from universities and other science-based organisations, they do not have the capacity for manufacturing and development themselves, and they are turning to the CDMO sector.
“There is a big expansion in the number of small research organisations that are discovering very promising mechanisms of actions or new treatments,” says Enrico. “But these companies need mid-sized CDMOs to help them structure and advance their drug development programmes.”
Enrico notes that many novel drugs have significant potential – a blockbuster product will provide a lot of margins at the end, but these small companies need to invest up-front to reach that stage. Those companies are looking for the right affordable and responsive CDMO partners, who can help them reach their drug development and manufacturing goals.
Go with the flow
Flow chemistry offers numerous advantages over batch manufacturing, but the technology tends to be under-used in pharma because, under pressures to get to market quickly, companies do not have time to develop flow routes for their products.
“A novel route of synthesis implies a lot more study and justification,” says Enrico. “At the moment, people generally use flow to solve a particular chemistry challenge, but really it should be used more widely… The paradigm change should be that as soon as you have a molecule, you should start to enquire about flow chemistry.”
Enrico admits that flow chemistry has some limitations – notably that you need to have a quick reaction, and there may be some concentration issues. However, flow chemistry can offer faster, safer reactions, with rapid reaction optimization, cleaner product, easy scale-up, and reaction conditions that are simply not possible using traditional batch methods. In addition, Enrico pointed out that flow is far more energy-efficient that large-scale manufacturing.
Pharma products seems to be getting more potent, driving demand for HPAPI. We asked Enrico was he thought is driving this trend, and what the industry should be doing to adapt to future demands.
“The driver is the selectivity of new molecules, that are now very much targeted, so you can get to a therapeutic level with less concentration,” he says. “The situation that is evolving to ‘less is more’ as we try to treat people with less active, which should be safer while providing optimal, targeted efficacy.”
However, while the market may be embracing high potency, the development of HPAPI is a very capital-intensive asset – for sample, requiring a special high potency suite for manufacturing. This is a big investment for a company to make at an early stage of drug development, when a successful outcome from a clinical trial programme isn’t yet known. This is why more companies are turning to CDMOs with this kind of capability.
Digitalization is a hot topic and Enrico is enthusiastic about its applications within the CDMO space, in particular the advantages associated with the integration of processes and the application of data for enhancing those processes to optimize output.
“The first step is to integrate all of your processes, and with this integration you will immediately have new digital tools – for example, for calculation capacity,” he says. “Then, once you have a system integrated, you can use the data that are generated to look at process modelling. You take all of the information and use it to improve your processes – you can rearrange your parameters, and experiment with what will give you the best output.”
By taking steps such as these, digitalization can improve plant safety, reduce downtime, optimize processes, and lead to more consistent, top-quality product. In addition, it is very helpful in compliance – it is possible to digitize processes to align with GMP requirements, for example.