Medical grade polymer synthesis is a unique capability that continues to grow in demand as the medical industry turns to GMP polymers for controlled release drug delivery, bone regeneration and dental substitutes, implantable devices and other applications. The market is being driven by worldwide growth in chronic diseases as well as advances in technology combined with a better understanding of drug metabolism in patients.

Additionally, medical grade polymer synthesis has grown substantially over the past few years thanks to advantages of its applications over conventional oral dosage forms.  For example, implantable medical devices enable site-specific drug administration to wherever in the body the drug is most needed.  The site-specific drug dose can often be lower, minimizing potential side effects for patients. 

But perhaps the biggest growth driver is the increase in patient convenience.  Slow release and controlled release formulations that take the place of daily injections, thus reducing the frequency of drug administration, may lead to an increase in compliance with treatment regimens.  Insulin, anti-cancer and anti-infection drugs—among other therapeutics—are also being administered directly into the body by employing polymers.

Essentially, polymeric devices, and drug substances formulated with a polymer as a functional excipient and injected, help in expanding the effectiveness of the drug being delivered by controlling release time of the drugs in the body.  

Polymer synthesis in action

Polymer synthesis, also called polymerization, is a process through which monomers, or small molecules, are bonded to form a polymer chain or network.  Polymerizations occur in many forms and are created through the repetitive chemical bonding of individual monomers.  Assorted combinations of heat, pressure and catalysis alter the chemical bonds that hold monomers together, causing them to bond with one another. Most often, they do so in a linear fashion, creating chains of repetitive molecules. 

The new polymeric materials developed are essential for creation of the rapidly growing number of combination products that are becoming so prevalent in pharmaceutical development. Examples include insulin pumps, drug-eluting stents and a host of innovative drug delivery systems that provide important new therapies for patients –and new revenue streams for sponsors.

The challenges of polymerization call for experience, expertise

While developing any New Chemical Entities (NCEs) always involves challenging new chemistry, the chemistry involved in creating and manufacturing medical grade polymers is far more difficult for the following three reasons:

  • Physical characteristics of the equipment such as vessel geometry have a far more significant effect in polymerization, especially when processes without solvent are considered.
  • Process variables linked to both mass and heat transfer such as agitation and temperature controls often have an outsized influence on the quality of the final product and must be carefully, knowledgeably managed.
  • Effective scale up, upgrading of GMP-compliant manufacturing requires significant skills and know-how that are largely influenced by experience.

A specialized industry with specific GMP-level requirements

Many customers come to Seqens CDMO for development, scale-up and manufacturing of GMP-grade polymers since it is a highly specialized area.  Advanced polymer manufacturing projects require sophisticated analytical techniques. Only a small handful of companies offer the same level of expertise as Seqens CDMO.

When choosing a CDMO to assist with polymer processes, companies should look for this expertise. They should also look for the ability to develop and manufacture in one organization both the polymer and any polymer-based technology that may be required for the combination products that are becoming more and more prevalent in pharmaceutical, nutraceutical and personal care development.

Ensuring the highest level of GMP quality and expertise in this unique specialty, whether for drug delivery or medical materials, is essential to its safety and success.

PLA/PLGA copolymers, Vitamin E TPGS for drug delivery

Seqens CDMO has nearly 20 years of experience creating polymers for drug delivery.  Our PLA/PLGA biodegradable EXPANSORB® copolymers are ideal functional excipients for controlled release applications. Used in FDA-approved parenteral drugs (Microspheres and implants), they offer excellent biocompatibility and controlled biodegradability.

Bioavailability is also an important consideration for companies developing pharmaceuticals, nutraceuticals and cosmetics actives. To meet that need, our Vitamin E polyethylene glycol succinate (or Vitamin E TPGS) , a surfactant, is used as an emulsifier, drug solubilizer, absorption enhancer and as a vehicle for lipid-based drug delivery formulations. Additionally, it acts as a thermal binder in extrusion processing, and as a carrier for wound care treatment. It also reduces drug sensitivity on skin or tissues.

GMP polymers for medical devices

In addition to developing and manufacturing Vitamin E TPGS and functional excipients for controlled release and other drug delivery applications, Seqens CDMO has deep expertise in producing GMP polymers for biomedical applications including:

  • PLA/PLGA resorbable polymers.
  • Purification media for therapeutic proteins.
  • Chemicals for diabetes monitoring.
  • Medical-grade PEKK, a thermoplastic poly-Ether-Ketone-ketone polymer for durable medical use in dental, permanent implants, and 3D printing applications.

Regulatory focus

Even when approved drugs are used, combination products that include a drug component coupled with a polymeric delivery mechanism are considered as new by the EMA and FDA.  They must undergo a rigorous de novo  approval process.

We have become quite adept at scale-up of polymers partly because we continue to tweak all aspects of medical grade polymer synthesis and manufacturing for efficiency, and at the same time maintain the highest quality standards, meticulously documented, always with an eye to winning regulatory approval.

Ongoing process optimization

As with API synthesis, polymer synthesis involves numerous essential, rigorous processes. Seqens CDMO is fully committed to process optimization.  We make every effort to put that knowledge to good use, noting lessons learned for greater efficiency in completing projects.

Finally, development/manufacturing/regulatory approval process is expedited when the same CDMO team developing the polymers also performs the cGMP manufacturing, has broad experience in polymer synthesis, and has core expertise in scaling up polymers to GMP.

Want to know more about GMP polymer synthesis capabilities at Seqens CDMO? Please contact us online at https://www.seqens.com/en/contact/ and we will quickly respond.

Interview conducted with Karine SALIM – Global Category Manager – Drug Delivery and Medical Materials.