Life Sciences

Focus on inhaled biologics and nasal delivery trends

Q&A with Dr Shabbir Mostafa, Head of Business Development, Advanced Delivery Systems Business Unit of Recipharm.

Q: Hello Shabbir. Please tell us about your role with Recipharm.

A: I’m with the Advanced Delivery Systems Business Unit. This business unit looks at three main areas: respiratory, nasal and auto-injector delivery. My team promotes and sells the platform, including the different services we offer customers. This goes from development to clinical, through to commercial manufacturing, including the device. We work on five main platforms, single dose nasal spray, a multi-dose nasal spray, pressurised metered dose inhalers (pMDIs), auto injectors and one of our newest technologies, soft mist inhalers (SMIs).

Q: Broadly speaking across all delivery methods, what are you seeing for trends today in the market?

A: It depends on what you are looking at. If you’re looking at inhalers, I think the big one now is sustainability. As you know, pMDIs – pressurised metered dose inhalers – are formulated with HFCs (hydrofluorocarbons), which are in a phase-down process at the moment.

Governments are saying we can’t use them because of their high global warming potential. The alternative propellants, we call them green propellants, are coming on to the market. They are low-GWP, so low global warming potential and have a lower carbon footprint.

It requires a lot of work from the companies to redevelop their formulations with these new propellants. There are advantages and disadvantages of using these new low GWP-propellants. However, it’s a huge area of interest because a lot of the big pharma companies have made statements about having net-zero carbon footprints. Some of these companies have significant pMDI products in the marketplace. So, they really need to change their propellants as quickly as possible. We can help with pMDI formulation using the new green propellants and also with our Bespak® valve range, which we have been developing to ensure optimised performance with the new propellants.

Thinking about inhaled biologics, there is a lot of interest in our Resyca® soft mist inhaler, because we have spray technology that enables the delivery of sensitive biologics like mRNA without the material being damaged by the shear forces typically applied by the more commonly used nebulisers. It’s exciting to know that drug delivery technology is enabling things like inhaled Covid treatments, or Cystic Fibrosis treatments, that the market struggled to deliver in the past.

Q: More specifically, what are you seeing for trends in terms of nasal delivery of therapeutics?

A: There are two types of nasal delivery: multi-dose nasal spray, which has been on the market for a long time; and single dose nasal sprays. Single dose nasal sprays are increasing in popularity because of their effective use. They’re used in things like rescue medicines for overdosing. For example, fentanyl overdose (an epidemic in the USA) uses naloxone in a single dose nasal spray, which gives immediate rescue from overdosing. We’re seeing a huge increase in these requests from customers looking for rescue medicines.

The single dose is also being used in pain relief and we also think there could be a market for it in vaccines. For vaccine use, it is very easy to use a single dose in your nose and a lot easier than using an injector, and there’s even some evidence emerging that with things like Covid vaccines, the nasal cavity could give added immunity benefits vs. the parenteral route. That’s where we’re seeing the market at the moment. We are still in the development phase of our device, but we’re hoping to be able to market it very shortly in partnership with clients.

Q: Is there such a thing as a ‘typical’ customer for Recipharm?

A: We tend to have customers going from one person in a virtual company, all the way through to multi-national companies. It all depends on what they need and what they’re looking for in terms of services. With smaller biotech, virtual companies, you expect to sell lots of services from development through to clinical, and maybe into commercialisation, depending on their requirements. Whereas the big multi-national companies will come to you because there’s a need or there’s a device that they may require, but they may not require all our services. They may just want to buy the device, they may just want to look at development or they may look at commercial capacity depending on what they have themselves. It varies from customer to customer.

Q: Describe the range of services you can offer customers, both large and small.

A: We have four business units within Recipharm. We have oral solid dose, which looks at the tablets, capsules and granules. The second one is sterile fill-finish, which is sterile products, ampules, vials, aseptic, terminal sterilisation and lyophilisation as well. The third is our latest business unit, biologics. We’ve bought a number of biologics sites over the last 18 months and we’re developing them and bringing the sites online as a part of Recipharm. The fourth one, as I mentioned, is the Advanced Delivery Systems business unit, where we offer services from development through to clinical and commercial product supply, as well as offering the device. Not many CDMOs offer all of this under one roof, which is what we think is our real differentiation in the marketplace.

  1. What goes into the decision on what device and type of delivery works best for a drug candidate?

A: That decision depends on the customer. They’ll tell us about their product and the delivery that it needs. We will advise on the best delivery option we can offer, whether it’s in a pMDI inhaler, or dry powder inhaler (DPI), or whether it’s a nebulizer or an advanced SMI. We look at the different formulations and different technologies and advise the customer the best way to go. Sometimes, the customer already knows what they want to do, so we follow their lead.

A lot of customers want us to show proof of concept and first-in-man studies. If you go down the respiratory route, we normally go through a nebulizer device delivery. That is a quick solution to get Phase 1 results and clinical results, as quickly as possible. Then, at a later stage, they may convert it to something like a DPI from a nebulizer – it really depends on the customer. If they’re working with an API unstable in solution, they may be able to just get Phase 1 out of the way, but then they know they need to convert at Phase 2 into a DPI.

Q: You must work with them then on the forms of dosage – the ones that are going to be most effective in terms of uptake of the therapeutic itself?

A: We try to advise on what’s the best way to go and the best route for the customer, but at the end of the day, it is customer-led. It’s a customer product and we are still always led by what the customer wants.

Q: Do you consider yourself a provider of integrated drug development and commercialisation services?

A: That’s what we believe because we can offer the formulation development, the analytical development straight to clinical batches through the clinical supply centre, then commercial supply and the devices as well, so we have a really integrated service.