How CDMOs Can Help Small Biotechs Meet Timeline Goals for Their Product Pipeline

They have many requirements, but right at the top of the list are shorter lead times and more flexibility to meet changes in demand. This includes phase-appropriate systems with early-phase requirements being very different from those for late-phase and commercial products. Of course, they also want access to expertise on different technologies so challenges can be identified and solved quickly. They also want clear and timely communication alongside exceptional program management.

The faster products can go through the pipeline, the sooner it will become available for patients and start making a return on investment made in its developments. There will always be uncertainty in the drug development process, but being able to adapt quickly when requirements change is essential if planned timelines are to be adhered to. Flexibility is key for delays to be avoided, as is the agility to amend activities as priorities change in light of clinical results.

First and foremost, a wide range of assets and enabling technologies for clinical development, backed up by a team of experts with a broad knowledge of and experience in these technologies. There should be a continuous investment to introduce new technologies as they emerge, and the ability to adapt facilities to keep up with the changing drug development landscape. This should all be backed up by a multitude of supportive functions from toxicology to engineering to quality, and, of course, regulatory affairs.

Our integrated capabilities make us stand out, enabling us to act as a single-source partner across the development process. We have a worldwide team of experts, an incredibly broad knowledge of different technologies, and the ability to address technical challenges early, alongside a full range of supporting functions. Our flexible and comprehensive phase-appropriate service and business models, including those that are specific to early-phase clinical developments, are key. We work all the way from feasibility studies, through clinical trials, to commercial supply. In 2021 alone, we supported more than 250 different clinical-scale small molecule projects. Importantly, we work with a full range of small molecule active pharmaceutical ingredients (APIs), including highly potent active pharmaceutical ingredients (HPAPIs) and cytotoxic payloads for antibody-drug conjugates (ADCs). This is complemented by a comprehensive suite of particle-engineering services and the ability to create and make a wide range of oral solid dosage forms from tablets to inhaled products. All of these are offered in a phase-appropriate way, backed up by all the necessary characterization and manufacturing services. Even though functions might be at different sites, each project is assigned one program manager, offering a single point of contact for our customers.

We absolutely work on late-phase projects and with large pharma companies; that is, of course, still true. But the majority of our work is in the early stages of drug development and with small biotechs, who are extremely unlikely to have manufacturing capabilities in-house or the technologies and the capabilities to carry out scale-up studies. Working with a CDMO like Lonza, which is offering integrated services, is critical to their business success, enabling them to minimize investment risk while advancing their products through the development pipeline as quickly as possible.

At the heart of the success of an integrated offer in achieving speed to market is the fact that everything is done by a single supplier. Delays are inevitable when transferring a product from one supplier to another or when more than one is working in parallel on the different facets of a project. Working with a single, integrated CDMO means that the teams from different functions are embedded in the same culture and often even in the same location, making communication between them almost seamless. Even when the teams are in different places, the lines of communication will be clear, and, as they will be used to working with each other, expectations will be clear. It also means that time is not lost in searching out and validating suppliers for each process. If one CDMO can do everything, it’s much simpler all-round. Working with a single-source CDMO shortens the timeline by an average of 14 weeks, which is significant.

Clearly, our integrated global network of science technologies and experts is hugely advantageous for a small biotech, as we are a one-stop-shop for the entire development process. But there is far more to it than simply process development, manufacturing, and formulation, as well as all the analytical services that go alongside them. Our regulatory team, for example, supports small biotechs with their filings with the regulators. They know what the different regulatory authorities are asking for and looking for because they are used to working with them. This insight is able to maximize the chances of a rapid acceptance of the filings, reducing the likelihood of delays.

We are, of course, always investing in new technologies and capacity, which will help our small biotech customers advance their API projects more quickly. As an example, in recent years we’ve made huge investments in APIs at our site in Nansha, China. Our early-phase and large-scale GMP operations there have recently been joined by new API labs and kilolabs, which went online in late 2021. A mid-scale plant expansion came online in the fourth quarter of 2022. Our APIs are particularly challenging to work with because of the containment requirements when handling them. The equipment and capabilities to safely handle them represent a significant investment. By working with us, small biotechs can take advantage of our investment in both equipment and expertise, something that may be too expensive for them to do themselves.

We are, of course, always investing in new technologies and capacity, which will help our small biotech customers advance their API projects more quickly. As an example, in recent years we’ve made huge investments in APIs at our site in Nansha, China. Our early-phase and large-scale GMP operations there have recently been joined by new API labs and kilolabs, which went online in late 2021. A mid-scale plant expansion came online in the fourth quarter of 2022. Our APIs are particularly challenging to work with because of the containment requirements when handling them. The equipment and capabilities to safely handle them represent a significant investment. By working with us, small biotechs can take advantage of our investment in both equipment and expertise, something that may be too expensive for them to do themselves.

A good example is a phase II clinical supply project for a small molecule drug. When we received the project, the small molecule drug was a free base, but the customer then realized they would need a salt instead, adding another step to their manufacturing process. Further complexity was added because the customer had two different crystal forms of the salt to choose from, so we had to make both polymorphs for them to evaluate. This request arrived when the penultimate step of the synthesis was already running as a part of the 100 kg campaign in the good manufacturing practice (GMP) lab. We diverted the first 10 kg of free base made in the campaign to make test batches of two different salt forms, developing reliable processes for each. Finally, we determined the physicochemical properties and stabilities of both forms, which allowed the customer to make the final decision on which to take forward. The demo samples of the salts were ready in two weeks, and the customer’s timeline was kept to. This was only possible because of the adaptability of our team in Nansha, who immediately adjusted the kilo lab plan to allow the salt forms to be made quickly. It is a great example of our flexibility and agility.