The benefits of outsourcing inhalation drug development
When it comes to treating pulmonary diseases, inhalation drugs are highly popular due to their ability to deliver the drug dose directly to where it is needed. However, they do pose challenges for drug developers when it comes to devising new products for the market. They typically take longer to develop than other drug products and can be expensive too, requiring considerable investment to ensure the successful completion of a project.
Globally, the demand for inhalation products has surged in recent years, due to the growth in respiratory diagnoses.
These may be easy challenges for a large pharma to overcome, but for smaller organisations, they can be daunting. Failure to consider the need to match the delivery device to the formulation, or to consider the regulatory landscape in different target markets could result in the project failing to deliver, with severe implications for the drug developer.
Where outsourcing can add value
CDMOs are here to help companies – no matter their shape or size – to navigate this complex development pathway for inhalation drugs. From early-stage development through to commercial manufacture, outsourcing to a CDMO can help streamline development and minimise risk for pharma companies.
Here are some of the key areas where outsourcing can benefit a project:
• Preclinical development
It is vital to carefully consider the selection, production and characterisation of preclinical supplies – CDMOs can help in this area, providing supplies to customers, supporting them in meeting good laboratory practice (GLP) requirements and assisting in the completion of any required stability studies.
CDMOs can support customers in selecting a tailored approach when handling new molecules to streamline processes and optimise quality.
• Knowing where you are going
Before embarking on any product feasibility project, it is imperative to have a road map setting out precisely what you want the new product to achieve, the delivery system required and other aspects such as the required inhalation dose amount. By considering these ahead of the development of the active pharmaceutical ingredient (API), you can save time by ensuring the API is tailored to the needs of the finished product from the very beginning. CDMOs can support in creating this road map, providing expert guidance on delivery systems and other aspects of the product development process.
• Devising a phase appropriate and product specific strategy
Two of the key challenges for any company when developing a new inhalation treatment is the selection of appropriate sensitive analytical methods and the management of labour-intensive characterisation tests during the formulation development and testing stage.
CDMOs are ideally placed to support in this area. Their in-house experts are experienced in identifying the real root causes of any issues that arise during inhalation drug development. Their in-depth knowledge can help customers devise the right strategy to streamline the project, saving time and cost while optimising the quality of the finished product.
• Sharing knowledge and best practice
Working with a CDMO providing an end-to-end service allows a drug developer that may not be experienced in developing inhalation products to access expert input into their project from the very beginning.
It can also allow all-important continuity of the knowledge gained from each development stage through to the final registration. This can help tackle delays that appear during the tech transfer from R&D to clinical trial and to the other stages beyond, reducing time-to-market.
Outsourcing key to success
Globally, the demand for inhalation products has surged in recent years, due to the growth in respiratory diagnoses. With some three million people dying from common pulmonary conditions globally every year, healthcare providers need effective treatments to help provide the best possible quality of life for patients and to minimise pressure on medical services.
More and more drug companies are looking to meet this demand but, unless they have specialist inhalation experience, they may struggle to complete their development projects successfully.
By outsourcing to an inhalation specialist CDMO, however, they can overcome this challenge. As a result, they can benefit from advice and guidance on how best to formulate their product so that it gets to market quicker and achieves the best possible ROI.
For more information on how outsourcing can benefit your inhalation drug development project, read this Pharma Network magazine article, Considerations in outsourcing inhalation drug development.
Alternatively, you can contact our expert team here.