Inhalation development techniques for reducing time to market

While the development of new inhalation therapy drugs is growing in popularity, the tech transfer and scale-up stages present several complexities that are difficult for manufacturers to manage. To overcome these challenges, drug companies can opt to work with contract development and manufacturing organisation (CDMO) partners that offer an end-to-end offering from small to large scale manufacturing, therefore simplifying scale-up. There are also a number of development techniques and approaches that can help to reduce time to market.

Inhalation drug development challenges

Manufacturers face several challenges when developing treatments that use the pulmonary drug delivery mechanism. For example, the development of an inhalation therapy can entail costly fees – meaning this route of administration requires significant funding. This can be particularly challenging and pressurising for small start-ups within the sector.

Whether it’s a dry powder inhaler (DPI) or metered dose inhaler (MDI), manufacturers need to make sure that the dosage form they select is compatible with their target. As DPIs can be manufactured with more ease and active pharmaceutical ingredients (APIs) filled into a capsule, they tend to be the ‘go-to’ choice for manufacturers. In addition, while MDIs are often cheaper to manufacture and usually utilise a standard design, DPIs provide two medical device options such as capsule design or a reservoir filled DPI. These differences must be considered when deciding on the type of product to pursue.

Additionally, manufacturers are required to show regulatory authorities that their device doesn’t affect the drug or formulation. A common issue encountered across the sector tends to occur in the early stages. That is, companies often fail to consider the whole development process as they primarily focus on getting the formulation to patients. As such, when they get to a Phase III trial and introduce a medical device, they encounter problems that have not been thought about during initial planning. This results in timelines extending and costs increasing. 

To outsource or not?

There are many benefits to consider when choosing whether to outsource an inhalation drug development programme. Firstly, when a manufacturer works with a CDMO partner, they gain access to experience and technologies that they may not have access to in-house. In addition, CDMOs can help companies determine whether they can take the product all the way to market by giving advice on how it should be formulated.

CDMOs with specific inhalation drug development experience are particularly advantageous as they understand all the details involved. For example, they are aware of the complexities of analytical testing with next generation impactors (NGIs) and extractables and leachables (E&L).

While many companies can manage formulation development and manufacturing clinical trial material for early phases, not many have the capacity, scale or know-how to take products through to commercial manufacturing.  End-to-end CDMOs such as Recipharm can offer formulation development, analytical development and device testing and filling, as well as clinical and commercial manufacturing.

When selecting a CDMO for a project, manufacturers should consider the below:

  • The experience a CDMO has working with medical device companies in order to determine their degree of flexibility to meet specific product needs
  • The capabilities that the CDMO possesses, as well as the equipment they have access to
  • A CDMO’s experience of global requirements for inhalation products to ensure that their partner can navigate the regulatory landscape
Reducing timelines

In order to reduce time to market, drug companies should first start with the end product in mind. Thinking about commercial manufacture during the early development phases helps to make intelligent formulation decisions.

Time to market depends on whether the product is a new DPI or MDI, as well as whether it can be progressed using the 505(b)(2) regulatory pathway. Gaining early insight into factors, such as the type of equipment that needs to be employed, enables manufacturers to be more time efficient. For example, it gives them the opportunity to recognise whether an MDI route using an off-the-shelf device or a DPI route is most suitable for the product. Due to the DPI route requiring the development of bespoke equipment, it is a more time-consuming route to take. However, it is beneficial for manufacturers as the complex design makes it more difficult for competitors to emulate. 

While there are many factors to consider, if time is of the essence, ultimately simplicity is key when it comes to the formulation and the device.

Summary

The development of inhalation drug products has rapidly grown due to the increasing potential of pulmonary routes of administration for more localised therapies. In short, these routes of administration offer patient-friendly and effective drug delivery.

Partnering with a CDMO relieves manufacturers of the complexities associated with the development and manufacture of inhalation products. In particular, working with a CDMO helps to streamline the process of transfer and scale-up, with the potential to also reduce timelines.

If you’re looking for inhalation development support, we can help. Find out more about our end-to-end service offering Recipharm Inhalation Solutions here: https://www.recipharm.com/solutions/recipharm-inhalation-solutions

For the full article see:  https://www.epmmagazine.com/opinion/inhalation-drug-development-techniques-to-reduce-time-to-mar/