by Michael Morgen
Head of Advanced Drug Delivery Technologies
I am often asked why I believe an integrated service offering is so important for the pharmaceutical industry. When we look at recent changes in the sector, I think the reasons become clear.
In the past, it was normal for smaller biotech companies to sell or license their product early on in their development cycle. Now, there is a growing tendency to hold on to an asset until a later phase and often even commercialize it themselves. This includes 70% of the molecules in the pipeline at the moment.
For these small biopharma businesses, it is nearly impossible to manage every aspect of the process in-house. They simply don’t have the resources and cannot afford to wait the couple of years it would take to build them. The answer lies in outsourcing, which also provides the flexibility to change capacity and adjust timings.
However, outsourcing each individual operation is very resource intensive. If drug discovery is done in one place, drug substance is made elsewhere, and product formulation by yet another company, it can feel like a huge burden. It slows everything down and makes controlling the process really complicated.
By partnering with an integrated provider like Lonza, with capabilities across the whole supply chain from drug substance through to drug product, everything will be handled by a single supplier. It is far more convenient and much easier to control. It is faster. There are even regulatory benefits. As we use the same processes throughout, reporting is seamless, avoiding the complication of having to combine data from disparate sources.
Our model is all about being as flexible and integrated as possible. And we have run more than 600 small molecule therapy projects over the past year alone.
This model covers the full drug development journey, from customer API technology, through bioavailability enhancement, all the way to drug delivery. We have experts who support the design of synthetic routes, so we can help develop solutions that will achieve the best solid form. We have the capabilities to optimize these solid forms and develop the processes required to manufacture them. We also have the skills and capabilities to make the final drug products.
I have been working in drug formulation for two decades now, an activity that sits right in the middle of a drug’s journey from an initial idea to an approved product. These days, the molecules that reach us are more likely than not to be poorly soluble, which has a big impact on bioavailability. To counter this, we offer a range of bioavailability-enhancing technologies that can improve oral absorption.
Of course, this is just part of the drug formulation story. As part of Lonza’s new offering in solid form development, my colleagues and I have more opportunities to help our clients achieve a seamless transition from drug substance to drug product. Importantly, we can help them select the optimal combination of drug form and formulation technology. We sit at the key transition point between API and formulation, and it is particularly rewarding to be at the center of so many adjacent development activities.
Solid form screening and selection is a key part of Lonza’s integrated drug development services offering, and we work on projects from preclinical studies right through to commercial manufacturing. And our work on the solid form informs so many downstream processes. How is the drug substance best isolated? Which solid form is best for the chosen formulation technology? And what impact will it have on the final drug product?
The drug development process can save much time and effort by gaining an early understanding of the solid form landscape. For preclinical work, it is important to identify a robust drug form that can be repeatedly isolated from a scalable process. The solid form is often integral to formulation technology selection, for example, when looking to enhance bioavailability via a high-energy salt or co-crystal.
Assessing the solid form of the drug with an eye toward developing a stable, scalable manufacturing process and a drug product with good bioavailability requires a great deal of expertise across disciplines. These include process development, science of scale, in-depth analytical capability and, of course, extensive formulation experience is essential.
At Lonza, we have developed a boutique, scientifically strong solid form offering for our biotech clients. At its heart is a close collaboration with our client partners, working in a fast and flexible way to meet the accelerated development timelines that are typical in the industry today. Our aim is to integrate the isolation of the drug substance with downstream preformulation characterization and formulation technology selection activities. The result? Efficient and effective development of the drug product.
In the pharmaceutical industry today, drug development speed and quality are at a premium, especially for those smaller innovative companies who are keeping ownership of their molecules further into development. These companies need expert partners who can help them develop their medicines in a timely fashion.
In particular, CDMOs who offer a full suite of integrated drug development services can be a great asset to these biotech innovators, as they can help a company achieve faster timelines while also reducing risk. We feel that our extensive expertise in material science, allied with our focus on the integration of solid form assessments with manufacturability, stability and performance of the drug product, is a differentiating capability in the CDMO space.
What’s more, we really listen to our customers. We take the time to get to know what they need, their goals, and how we can best support them. We’re not just an integrated supplier – we are a truly integrated partner. We work together as one with our clients. Personally, I find that makes my work even more meaningful. And it definitely delivers better outcomes for our clients and their patients.
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Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.
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