Sometimes when preparing an elaborate meal in the kitchen, it can take longer to clean up than it does to prepare the main course and side dishes. Think of all the pots, pans, kitchen gadgets and cutlery involved. That’s especially true if you’re making something like risotto, which requires constant stirring as more and more liquid is added during cooking. In addition to requiring constant attention, risotto has a tendency to stick to the side of the pot if not constantly scraped. I once tried a pressure cooker recipe for risotto. It tasted great and cut down on the stirring but the burnt residue at the bottom of the pan took two days of soaking, a good amount of scrubbing after that, followed by more soaking and scrubbing until, finally, the pot was completely clean and could be used to make other meals.
The same issue arises when synthesizing medical grade polymers to meet the growing demand for these useful molecules. These polymers can be used to make numerous medical products. They include drug delivery devices, implantable medical devices, biodegradable implants, nano-particles, combination Active Pharmaceutical Ingredient (API)/polymers, excipients and medical-grade coatings, among others.
Our previous article described the 7 key steps used in developing medical grade polymers. They include:
- Controlling particle size and composition.
- Targeting molecular weight.
- Polymerization for defined molecular weight and copolymer composition.
- Introducing an active functional moiety.
- Incorporating particles into delivery mechanisms.
- Manipulating physical properties to achieve narrow particle distribution.
Not all steps are required for every project, but each of these steps requires specialized equipment. That equipment, in order to be ready to perform these processes, must be pristine and devoid of any potential contaminants.
There’s a cost for that. This article focuses on the top four costs related to developing polymeric materials.
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Cleaning is the #1 cost
One of the most difficult – and expensive – aspects of synthesizing medical grade polymers is cleaning out the significant residue left behind in the equipment used to make them.
Among the worst offenders are cross-linked co-polymers. They are particularly difficult to clean out. So much so that the cleaning itself requires a separate R&D process in its own right.
This elaborate cleaning requirement adds to the time – and therefore the costs –of polymer synthesis. It counts as billable time in the lab or manufacturing plant, much as a restaurant factors into its menu prices the full cost of preparing the meals it serves up.
#2 Meeting physical specifications
Compared to making APIs, medical grade polymer synthesis is made far more complicated by the fact that physical characteristics play outsized roles.
Medical grade polymeric materials must meet both chemical and physical specifications. Chemical specifications are no more difficult to meet than any other new chemistry that CDMOs routinely develop. All chemical reactions, whether for API synthesis or polymer synthesis, go or they don’t go. It’s a trial and error process until the chemistry is established.
But it’s a different story when it comes to the physical properties that are so crucial to medical grade polymers.
In polymer synthesis, chemical properties and mechanical properties are intertwined. Affecting one affects the other, adding much greater complexity. Changing any variable requires testing to assure that other, inadvertent changes did not occur. It’s a slow, stepwise, but necessary process required to develop compounds like this.
Managing the following physical properties therefore adds complexity, time and cost to the equation:
- Particle size.
- Particle composition.
- Particle distribution.
- Molecular weight is an important variable that influences a polymer’s mechanical properties.
#3 Creating monomers
Monomers are the starting materials for polymerization, and can be quite expensive to create. However, that expense is warranted given their large influence on the final product. Whether purchased commercially or created in our labs, monomers must meet high quality and impurity standards if they are to become part of a polymer for therapeutic purposes.
#4 Raw materials
Want to make your risotto with truffles? It’s going to cost you. The Arborio rice is a commonplace commodity that can be purchased in most supermarkets, but truffles can be hard to find and their price is high. Likewise, the cost of polymeric materials will reflect the availability, rarity and quality of the raw materials required.
There may also be reasons beyond your control that could impact raw material prices. Weather events might delay shipping, reducing supply and raise prices. Materials may arrive that do not measure up to quality standards and must be replaced. A batch may be found to have different impurities than other batches of the same material. These are just a few of hundreds of reasons why the cost of raw materials can fluctuate.
For more articles about polymer synthesis and costs, check out: “Choosing the Right Agitation for a Polymer Synthesis,” “How to Keep CMO Costs Down During the Process Optimization Stage of Drug Development,” and “How to Keep Costs Down During Initial Stages of Contract Manufacturing Organization (CMO) Engagements.” Or to ask us more directly about cost-related issues when it comes to cGMP manufacturing, call us at (978) 462-5555.