Angshuman Pal- Senior Scientist, Research & Development, SGS North America, Inc.; Michael Morgen- Head of Advanced Drug Delivery Technologies, Lonza; Jakob Bonde- Director, Regulatory Affairs Regulatory, Lonza.
What are the current trends in pharmaceutical drug delivery technologies? How has the industry evolved over the past two years, and what innovative approaches have emerged to improve drug delivery efficiency and patient outcomes?
Angshuman Pal, Senior Scientist, Research & Development, SGS North America, Inc.: Nanoscale drug delivery systems are at the forefront of innovation, where materials in the nanoscale range are employed to deliver therapeutic agents to specific targeted sites in a controlled manner. These systems utilize nanocarriers to precisely deliver drugs to specific sites, resulting in increased efficacy and reduced side effects.
Nanocarriers based on liposomes, polymer micelles, and nanoparticle systems have gained extensive popularity for their effectiveness in targeted drug delivery applications. These advanced delivery platforms offer tailored approaches to transport therapeutic agents precisely to their intended destinations within the body.
The strategic design of intelligent nanoparticles has the potential to enhance efficacy in various delivery applications and simultaneously enable customized designs for precise targeting, leading to overall improved patient outcomes. This innovative approach harnesses the power of nanotechnology to revolutionize drug delivery and medical treatments.
Michael Morgen, Head of Advanced Drug Delivery Technologies, Lonza: In recent years, innovators have had a growing reliance on partnering with CDMOs with expertise in drug formulation and delivery, as this can enable the best possible technical solution that meets their desired target product profile to be found more quickly.
While this is particularly the case for small biotechs, large and mid-sized pharma can find this form of partnering advantageous by access to new technologies without having to develop expensive niche capabilities in-house.
The ongoing trend for molecules to be insoluble continues to pose oral formulation challenges. Increasing numbers of larger ‘small’ molecule drugs such as protein degraders, with molecular weights above 500, are being developed, too, and these also require innovation to create bioavailable oral dosages, including the use of amorphous forms.
There is also growing interest in extending oral delivery to biologics such as proteins and mRNA. It may be possible to improve efficiency and safety, as well as reduce costs, by delivering biologics in a site-specific way, such as by inhaled delivery, which is more patient-centric than injection or infusion. Dry powder formulation may also improve the shelf stability of biologics at ambient temperature, cutting costs and increasing availability in places where cold-chain storage is challenging.
How has the COVID-19 pandemic impacted drug delivery technology development and implementation? Have there been any specific challenges or opportunities arising from the pandemic that have influenced your company’s strategies?
Pal: Drug delivery technology development was impacted in several ways by the COVID-19 pandemic. Specifically supply chain and operational disruptions. The pandemic disrupted global supply chains, affecting the availability of raw materials and components necessary for pharmaceutical manufacturing and laboratory testing. This challenge has led to delays and potential shortages in drug production. Lockdowns, social distancing measures, and workforce availability issues impacted the operations of SGS in the same way as any other CDMO and the pharmaceutical industry overall. Overall the industry has become more agile to develop new solutions and get them to market faster as evident by the rapid availability of vaccines to treat COVID-19.
The pandemic also highlighted the importance of innovation in pharmaceutical manufacturing. As a CDMO, SGS expanded services into research and development, which is heavily tied to formulation and analytical development, as well as drug delivery technologies to meet the increased demand for services.
SGS took strategic steps to achieve closer collaborations with our suppliers to ensure supply chain resilience thus exploring more innovative manufacturing techniques resulting in accelerating production processes.
Morgen: One of the challenges arising during the pandemic was that it placed urgency on the industry to develop treatments and vaccines for COVID-19 on an accelerated timeline. This, of course, also represented a real opportunity for the industry. Organizations that could respond rapidly and effectively could make significant positive contributions, as long as they could make a step change in both thinking and workflows. The rapid progress made with COVID-related treatments and vaccines demonstrated what was possible, and set a precedent for agile development programs across modalities for a range of therapeutic areas and indications.
COVID also forced the adoption of new ways of working and collaborating in the industry, with a heavy emphasis on remote work and virtual meetings. Again, those organizations able to adapt to these new paradigms were able to successfully execute internal or contract-related development programs effectively. Those new work models have, to some extent, persisted.
What are the best practices your company follows in developing and commercializing drug delivery technologies? How do you ensure that your solutions meet regulatory standards while maintaining a focus on patient safety and efficacy?
Pal: Pharmaceutical Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in developing and commercializing drug delivery technologies. SGS takes a collaborative and early involvement approach, where we work closely with pharmaceutical companies, sharing expertise and insights to jointly develop innovative drug delivery technologies that meet specific therapeutic needs. Early-stage involvement allows us to provide valuable input on formulation, delivery methods, and regulatory considerations. We tailor our services to the unique needs of each client providing solutions that align with the drug characteristics and the targeted patient population. We are equipped to seamlessly transition from small-scale development to large-scale commercial manufacturing. Dedicated project management with open and transparent communication with our clients is key to our success. Our quality team ensures that our process meets necessary safety, efficacy, and quality standards at every stage of development and manufacturing with accurate and comprehensive data collection and documentation.
In summary, SGS effectively helps our clients, overcome complex drug delivery challenges, while reducing risks and meeting global regulatory requirements to accelerate products to market.
Jakob Bonde, Director, Regulatory Affairs Regulatory, Lonza: We follow the ICH guidance, and the ICH guidance interpretation and legislation from the major markets, including the US, Canada, the EU, the UK, Switzerland, China, Japan, and Brazil. We also make use of the experience we have gained from questions in multiple customer applications, and the acceptance of responses. Pharmaceutical manufacturing quality is an inherent component of any application for marketing approval, along with clinical and non-clinical data, to ensure patient safety and drug product efficacy.
Considering the diverse pharmaceutical industry segments, how does your company envision the future outlook for drug delivery technologies in each segment (e.g., oncology, central nervous system disorders, immunology)? Are there specific areas where you see substantial growth potential or heightened demand for innovative drug delivery solutions?
Morgen: There is tremendous diversity in terms of therapeutic areas, but this diversity extends to modalities, targets, delivery routes, and even regulatory hurdles. These all contribute to a challenging environment. Taking oncology as an example, a substantial fraction of small molecule NCEs require the application of formulation technologies to achieve acceptable oral bioavailability.
Oncology programs are typically on accelerated pathways, but meeting rapid timelines has become even more challenging with the introduction of Project Optimus, the FDA’s dose optimization initiative, where a maximum tolerated dose approach is no longer acceptable for oncology INDs. Dose optimization studies are required, and a model-informed approach to predict drug absorption and determine the first-in-human dose has become critical. Here at Lonza, we use tools such as solid form screening and selection, combined with physiologically-based pharmacokinetic (PBPK) modeling, to select the optimal technology to meet target product profiles.
In the CNS area, there is the additional issue of the blood–brain barrier. Nasal delivery is one route that might prove beneficial, and it also has potential in immunology. Dry powder nasal vaccines avoid the need for cold chain storage, too. Advanced spray drying technology is now enabling dry powder pulmonary delivery of biologics for respiratory and oncology applications.
In light of the changing global healthcare landscape, how does your company collaborate with stakeholders such as pharmaceutical manufacturers, healthcare providers, and regulatory authorities to ensure the successful adoption and integration of your drug delivery technologies? How do you address the unique needs and requirements of different markets and regions?
Morgen: For a CDMO, especially one that frequently employs innovative and enabling formulation and delivery approaches, it is important to have good collaborative working relationships not only with the pharma or biotech client but with the relevant regulatory agencies as well. In our experience, working closely together in, essentially, a single integrated cross-organizational team that includes both the client and the regulatory body is important for achieving a successful outcome, while also meeting aggressive timelines.
Early and frequent communication with all stakeholders is one key to success, as it helps ensure there is a common understanding of the approach, requirements, and challenges. We have had several cases in the past few years where we have commercialized delivery technologies with novel characteristics and had very positive and comprehensive interactions with both the client and the regulator. This has allowed us to address the unique aspects of these technologies, and thus facilitate the advancement of the client’s program.
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