To meet the demand for drug/delivery combination products, our growing team of Ph.D. polymer scientists tackle a wide variety of challenging projects daily. Thanks to the expertise of our cGMP Advanced Polymer Manufacturing and Development Group, new technologies continue to be developed, and pharmaceutical companies can differentiate their products from those of their competitors. Implantable devices are safer, sparing patients from dangerous infections. Combining drugs and delivery systems results in consistent, precise release of drug doses and offers more treatment options, which benefits patients and extends the lifecycle of pharmaceutical products.
This article will discuss how to keep GMP polymer projects on task and on schedule.
But first, just a few examples of the GMP polymeric materials we have created include:
These polymers have been used to make a variety of products, which if implanted into patients allows the active ingredients to be diffused over time in the body. They are used to deliver any number of therapeutics and treat numerous conditions.
Many polymer materials can penetrate areas of the body that typical actives can’t reach. Others, such as polymer-woven pouches can house electronic implantable devices, creating a barrier between the patient’s body and a pacemaker, for example. The medical-grade polymers we produce also include nano-polymer particle technology for delivery of therapeutics, excipients and medical-grade coatings.
SEQENS NA (formerly PCI Synthesis) is fortunate. Our Boston-area location puts us squarely in the middle of some of the most exciting, disruptive medical innovations being spun out of our area’s prestigious academic institutions and biotechnology companies, and we are honored to be asked to lend our expertise to their many next-generation projects.
In addition to our polymer development projects many companies come to SEQENS N.A. for the scale-up and manufacturing of GMP-grade polymers, a highly specialized area.
Our growing polymerization business is also our most complex as far as projects go. Like API development, every project involves new chemistry never done before. But when creating tomorrow’s therapeutics that involve a drug and its combined polymeric delivery device or mechanism, the complexity of the project increases greatly. Not only does the chemistry need to be developed for the API, but also all the performance specifications for its delivery by the polymer system we are developing.
Accordingly, development time is much
longer. Everything has to be put to the
test. If we are developing a coating for a device such as a stent, we have to combine
monomers to create the polymer chain, coat the device and put it through
extensive testing to make sure the drug/device combination works as intended, all
the while creating the analytics and documentation as we move from step to step.
We make every effort to take an inherently inefficient process and make it as efficient as possible. Sponsors looking for a CDMO to assist with GMP polymer projects would do well to choose one that not only has polymerization expertise and experience, but also one that can simultaneously develop and manufacture the API and polymer in one organization. It’s the best way to maximize efficiency.
While critically important in meeting project timelines, efficiency isn’t the only factor to consider. There are other concerns – among them regulatory approval. Even when approved drugs are used, combination products that include the drug plus a polymeric delivery mechanism are considered as new by the FDA. They must undergo the rigorous de novo approval process. The development/manufacturing/regulatory approval process is expedited when the same CDMO team developing the GMP-grade polymers has the expertise in scale-up and manufacturing of the combination product.
The greater the project’s complexity, the greater the need for close sponsor-CDMO collaboration as the project progresses. Projects move more smoothly when sponsors understand what the molecule is doing at each step of the way and know the effects of polymer synthesis on the product. This constant teamwork enables faster decisions and keeps iterations down as much as possible.
As we discussed in previous articles, polymer synthesis is a combination of science and art that, with the benefit of experience, informs the best path forward.
How things agitate has a significant effect on polymer reactions. It’s yet another variable to manage. There’s a need for just-right agitation equipment to assure, as is necessary in polymer synthesis, that you are agitating appropriately. As well, variations in the geometry of agitators can lead to different results. For some projects we have had to create custom-made agitators to give us the mixing results we were looking for.
Having the right equipment for the project or being willing to create the equipment that will accomplish the desired polymer synthesis can make the difference between a completed project and a failed project.
We have become quite adept at the scale-up of polymers partly because we continue to tweak all aspects of grade polymer synthesis and manufacturing for greater efficiency while maintaining the highest quality standards.