Accelerate the path to clinic for your nasal product
Securing funding and propelling innovative new therapies to patients demands speed.
Throughout your nasal spray development journey, you are likely to face pressure to accelerate timelines to clinical phases, stemming from the need to:
Shorten development timelines to bring life-saving therapies to patients sooner.
Build and retain investor confidence through the swift transition to clinical trial.
Conserve capital when operating under tight budgets, with accelerated timelines translating to cost savings.
Gain earlier market entry to capture a significant market share before competitors.
6 opportunities to successfully shorten your timelines
Accelerating nasal products to clinic is no easy task.
You must carefully navigate various complexities such as active pharmaceutical ingredient (API)
solubility issues while ensuring scalability.
A successful strategy should consider the following:
1. Dedicated clinical manufacturing equipment and processes
Dedicated clinical manufacturing lines help to prevent product loss and eliminate the need for costly modifications associated with repurposing commercial equipment.
2. Integrated capabilities
From formulation scientists to clinical manufacturing experts and analytical chemists, progressing nasal spray drug products relies on seamless collaboration.
An integrated approach, with all essential functions housed under one roof, fosters a streamlined and efficient development process.
3. Expertise to overcome API complexity
Complex APIs exhibiting poor solubility or sensitivity can lead to formulation instability and degradation, impacting product safety and efficacy.
Expertise and experience are needed to implement tailored solutions from the outset, preventing the need for troubleshooting and costly reformulations later.
4. Regulatory support
A specialist nasal spray contract development and manufacturing organization (CDMO) offering in-house regulatory support can assist in navigating the complexities of regulatory requirements.
5. On-site clinical and commercial scale equipment
A single facility with both clinical and commercial scale equipment allows for efficient early-stage development and seamless transition to large-scale production.
6. Ensuring scalability as the project progresses
Leveraging quality by design principles allows for proactive identification and control of critical quality attributes, facilitating seamless scale-up and minimizing costly rework or delays.
Ready to streamline your nasal product journey?
With unrivaled expertise and experience in nasal product development and manufacturing, we breathe excellence into nasal delivery.
Find out how we can accelerate timelines to clinic for your next nasal spray product in our whitepaper.
Download the whitepaper
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