In general, what are some current issues facing pharmaceutical companies in regards to formulating effective drug delivery systems?
A series of disciplines in the field of specialized parenterals including personalized medicine, nucleic acid APIs and gene editing are driving demand for advanced drug delivery technologies. These technologies must not only be safe and efficacious, but simple to customize and efficient to manufacture. Other common formulation challenges include the effective penetration of target cells, and ensuring extended release occurs reliably for either systematic or local delivery over days, weeks or months. Technologies such as lipid nanoparticles (LNPs), which can safely encapsulate the API to protect it against degradation while enhancing biodistribution and solubility characteristics, are well positioned to address such challenges.
Many pharmaceutical companies are seeking to partner with CDMOs that have established core competencies and a proven record for performance with specific drug delivery technologies such as LNPs. These strategic partnerships, which can span formulation and process development as well as manufacturing, must ensure the target delivery system is compatible with both the API and excipient. Specialized equipment, such as LIPEX® extruders, and manufacturing facilities capable of both aseptic processing and flammable solvent handling, can also be required to bring these products to market. The agreement we signed last year with Precision Nanosystems to develop and manufacture high-quality nanomedicines is an excellent example of how it can also be beneficial to collaborate to address other unmet market needs.
Why are lipid-based products emerging as a way to better formulate specific products? What are the advantages?
There has been a resurgence of interest in lipid-nanoparticle technologies over the last decade, given their well-established record of safety and proven ability to encapsulate APIs that would otherwise degrade before reaching the target site. We expect that this market segment will continue to grow as therapeutic targets become more specific, and demand increases for highly potent and gene-based drugs.
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One of the main advantages of LNP-based technologies is that they can reliably encapsulate high payloads for both hydrophilic and lipophilic drugs. That is a key reason why they are now the de facto standard to deliver nucleic acid-based vaccinations and other therapies, where the payload must be protected until such time as it can be delivered to the site to silence targeted genes or express therapeutic proteins. They can also be designed to exhibit specific physicochemical properties such as particle size, surface charge and surface function to satisfy a variety of performance requirements.
Can you tell us how Evonik is advancing lipid nanoparticle-based drug delivery systems?
Evonik continues to consolidate its position as a leader in the development of lipid nanoparticles, as well as other related technology areas including polymeric microparticles and implants that are required to deliver specialized parenterals. At our Vancouver site in Canada, our team has been supporting customers in the development and clinical manufacturing of lipid nanoparticle-based drug delivery systems since the 1990s. We provide the formulation and process development support to select a lead candidate, quickly advance the product into the clinic, and then support its scale-up and commercial manufacturing at our established U.S. facilities. We also provide LIPEX® extruders ranging from benchtop to commercial production scale.
To further encourage market growth within this technology area, we are making selective investments in nanomedicine research, and also developing new process technologies and biomaterials that will be required for certain personalized, RNA or gene-based therapies. We also continue to expand industry collaborations between Evonik and many of the world’s foremost scientific experts within the market.
What types of products benefit most from lipid-based drug delivery systems? Is Evonik working to expand this list?
Lipid-based drug delivery systems have been traditionally used for highly potent molecules such as anti-cancer agents, antibiotics or antifungals and oligonucleotides that require intravenous administration. While the market for nucleic acid-based vaccines and therapies is yet to reach critical mass, there are hundreds of personalized medicines in development that are expected to utilize these technologies moving forward.
Evonik is working with various customers to help ensure their RNA molecules do not degrade before they reach the target site so that delivery effectiveness increases by an order of magnitude. Other projects have helped to improve the solubility of lipophilic APIs, reduce systemic toxicity, and enhance biodistribution as well as cellular and tissue uptake. Demand for these specialized delivery technologies is also being driven by demand from patient groups seeking more effective therapies, and payers transitioning to performance-based reimbursement strategies.
What is your process for evaluating or recommending a product in development for a lipid-based drug delivery system?
Typically, pharmaceutical and biotechnology customers come to us with a defined target product profile that requires a complex drug delivery solution. We help them to not only match the fi t of their molecule to the right lipid-based drug delivery system, but also ensure the process is readily scalable into a commercially viable manufacturing process. We can also help determine if a customer’s drug might be better suited to other formulation technologies such as such as extended-release microparticles and implants. Following recent investments and strategic acquisitions across core technology areas, we believe that Evonik is uniquely positioned to serve our customers in the development and manufacturing of specialized parenteral drug products.
Looking ahead, how will Evonik continue to offer its current and future customers the best available lipid nanoparticle-based drug delivery systems and development capabilities?
Advanced drug delivery technologies are helping to enable and enhance the next generation of specialized parenteral medicines. That is why this market has become a core growth area for Evonik, where we are allocating significant resources to support new and existing customers in the development, scale-up and production of highly complex drug products.
We recently completed a significant expansion of our Evonik Birmingham Laboratories site in the U.S. state of Alabama, where we manufacture our own bioresorbable excipients and customer’s specialized parenterals at clinical and commercial scale. A state-of the- art aseptic filling line is also about to come online in Birmingham for the commercial filling of liquids, powders and suspensions into vials. In addition, we are investing in a major expansion of our R&D and CGMP manufacturing capabilities for lipid-based drug delivery systems at our Vancouver site in Canada. Such investments will further accelerate our ability to serve as a strategic partner with the necessary core competencies in design, development and production to help customers bring new, high-performance parenteral medicines to market.