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Q&A: The role of CDMOs in overcoming nasal drug delivery R&D and manufacturing challenges
Rohit Mulik, Senior Manager: Formulation R&D, and Eric Kaneps, VP, Sales & Marketing at Renaissance Lakewood LLC, answer questions about the challenges in nasal drug delivery and outline how CDMO partnerships can help to overcome them.

April 24, 2024

1. What trends are driving nasal drug delivery and why are pharmaceutical companies becoming more interested in this administration route?

Rohit Mulik: Over the last decade, drug delivery through intranasal delivery has grown significantly due to its compact design, ease of use and avoidance of first-pass metabolism. Although nasal drug delivery used to be reserved for locally acting treatments, interest in this administration route across several applications has grown steadily in recent years. It is now a promising delivery method for many indications, including seizures, migraines, Alzheimer’s disease or multiple sclerosis attacks, and cardiovascular problems.

The nasal mucosa is highly vascularized and immunogenic, which means it can be used as a fast-acting delivery route with high systemic availability that avoids first-pass metabolism. Another advantage is that nasal delivery products are easy to use, meaning patients can easily administer therapies themselves. When you consider these benefits, it’s clear to see why the pharma industry is increasingly using nasal delivery.

Eric Kaneps: This increased interest is driving the steadily growing global nasal drug delivery market, which was worth US$19 billion in 2022 based on research we funded through Clearview Healthcare Partners. This has included the development of new chemical entities (NCEs) as well as the repositioning of already approved therapies through the 505(b)(2) regulatory pathway. Repositioning injectable drugs or vaccines links back to the ease of use of nasal products, offering patients a non-invasive administration route.

As with any therapy, research and development (R&D) and clinical manufacturing are key to product commercialization and realizing the potential of nasal delivery. However, the growing interest has highlighted how challenging R&D and clinical manufacturing can be within nasal drug delivery. Growing demand has exacerbated existing difficulties, including navigating active pharmaceutical ingredients (APIs) with low solubility, strict regulatory requirements, and scaling manufacturing to meet demand.

2. Starting with R&D, what are some of the challenges developers face with their nasal drug delivery products and how can they be addressed?

Rohit: Nasal products are considered drug/device combinations which add complexity to their development. As part of R&D, nasal sprays require studies not only assessing pre-formulation and formulation development, but also nasal spray device selection, and spray method development to quantify drug/device spray performance.

It is important to conduct studies in parallel throughout development, as this ensures the final product will function as intended. This requires all teams involved in the development to work closely together, emphasizing communication and collaboration.

Eric: Pharma companies are increasingly partnering with contract development and manufacturing organizations (CDMOs) to support nasal product R&D. Nasal focused CDMOs have the technical expertise and experience in nasal drug delivery that developers need to help them overcome R&D challenges. CDMOs can therefore be relied upon to provide the communication and collaboration needed for successful product development. Partnerships can also support clinical manufacturing and scaling products for commercialization.

3. What are the advantages of partnering with CDMOs and what R&D services can they offer to help with nasal drug delivery development?

Eric: One of the main advantages of partnering with a CDMO is bringing together all R&D studies and activities under one roof. As experts in nasal delivery, CDMOs already have the processes in place to streamline R&D, meeting the needs of the project and avoiding any potential delays. Ultimately, this means critical therapies get to the patients who need them in a timely manner.

Rohit: An expert CDMO should be able to offer support at all stages of nasal product R&D, from pre-formulation and formulation development to validation and regulatory support. In between there is a whole range of services, including analytical development and spray device selection and characterization. Partnering with a CDMO from the early clinical phases of a project all the way to commercialization is a solid strategy for ensuring product progression.

4. After R&D, what are some of the challenges nasal product developers face with clinical manufacturing?

Rohit: Challenges in clinical manufacturing include varying batch sizes, limited amounts of API, aseptic requirements and working with different devices and containers, all with the pressure of meeting project timelines. Flexibility is key to overcoming these challenges. Nasal spray projects can vary greatly and CDMOs should be capable of adapting their clinical manufacturing capabilities to the needs of each project.

Experienced CDMOs should be able to adapt to demands by using cutting-edge technologies and thinking about the requirements of clinical manufacturing during the R&D phase to avoid potential issues during scale-up.

Eric: Specific services that CDMOs should offer to support clinical manufacturing with flexibility include dedicated clinical manufacturing suites to support small-scale fill and finish. Dedicated clinical filling lines often produce less waste and have the capacity readily available to support a quick transition from concept to cGMP production. 

It is also important for CDMOs to constantly update and develop their facilities, equipment, knowledge and processes. This ensures that their support is always at the highest standard, providing nasal product developers with quality, consistency, reliability and efficiency, both now and in the future.

5. What other challenges can nasal drug delivery developers expect in the future and how can CDMO partners help overcome these?

Rohit: The overarching benefit of partnering with a CDMO is the experience that they bring to the project. Nasal spray products are constantly evolving. APIs are becoming more complex, which has an impact on formulation and device design. Nasal product developers should look at a CDMO’s track record, which indicates if they have experience solving these types of issues. Years of experience can help to quickly identify and solve problems and ensure a successful product launch.

Eric: The other thing to consider after R&D and clinical trial material manufacturing is the product’s scale up needs and go-to market packaging strategy. Collaboration with your selected CDMO on these details will significantly reduce challenges as you approach your product approval date.  Again, the full-service integrated services that CDMOs like Renaissance Lakewood, LLC offer are very beneficial for nasal product developers. We offer support for developers from early development, all the way through to commercial manufacturing, providing seamless scalability and commercial success.

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