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Since I was a PhD student, I have focused on solid form screening, first as a postdoc at the Synthesis and Solid State Pharmaceutical Centre (SSPC), a global hub of pharmaceutical process innovation and advanced manufacturing in Ireland, then back at Kansas State University where I had studied. The opportunity to move to Lonza came a couple of years ago, and I am now fully focused on solid form services once again. 

The lack of communication between drug substance and drug product teams
From my time at SSPC, working on projects for various pharmaceutical companies, I know there is the risk that a CDMO’s drug substance group simply passes a project across a fence to the drug product group for further processing without any real communication. These two groups can appear very separate, with neither having a clear picture of what the other is doing. And in fact, that can happen, particularly when a small biotech uses different CDMOs for each stage of the project. Most of the time, things go well, with scientists and engineers on both sides of this fence doing their jobs effectively. But this is not always the case – sometimes, a drug substance comes across to the product team and there are challenges. For example, a change in polymorph can have an impact on properties (solubility / stability) that no one on either side could have predicted as this was not at the forefront of their thinking. Resolving the issue at a later stage can both be costly and time-consuming. 
Developing seamless communication between two teams
Here at Lonza, we want to remove that fence. Rather than blindly throwing a ball back and forth across the fence, we have developed an integrated, seamless and joined-up offering. We have a group who can speak the language of both the Drug Substance and Drug Product teams, and who can make sure the lead form is identified prior to formulation.


This is the role of the team here in Solid Form Services. We strive to tear down that fence and create a solid form that is appropriate for both the Drug Substance team and the Drug Product team. We combine our solid state chemistry, material science, formulation design and bio-modeling expertise to establish this strong connection and understanding. And this can accelerate development timelines. Developing a drug does not only require understanding the chemical structure, but the physical characteristics as well. The physical structure directly impacts the characteristics of the resulting product, such as solubility, purity, and bioavailability. The physical characteristics of a drug product can also impact how we process that drug further down the line in drug product development. 

Deciding the ideal lead formulation to meet tight timelines

We help our customers to decide before the drug product formulation step whether the ideal lead formulation would be a crystalline polymorph, a salt form, a cocrystal, or an amorphous spray-dried dispersion. Performing this step right after the drug substance development step is finalized brings many benefits in meeting tight timelines of the overall drug development life cycle. Getting from an initial batch of API to an optimized solid form with a target product or drug profile can take anywhere from two to eight weeks, depending on the complexity of the solid form landscape and the degree of risk reduction desired by the client. Typically, four to six weeks is a reasonable timescale. 

Working collaboratively with our clients

The great thing about Lonza is that we work as one with our clients. Our model has the flexibility in scope to be adapted to suit their individual needs for their particular program. We are a big business, but our people are right at the heart of every project and every relationship. 


Want to know more?

If you're interested in how we work or learning more about our Solid Form Services offering, simply contact us

 

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