Enabling In-Home Drug Delivery With SMC's Asmita Khanolkar

Methods for enabling self-administered, in-home delivery of drugs and biologics must accommodate increasingly larger volumes and more complex formulations. In this episode of Supplier Horizons, host Tom von Gunden talks with Asmita Khanolkar, Senior Director of Pharma Services at contract manufacturer SMC Ltd., about patient-centric considerations such as ergonomics and tolerability in the development of combination products, autoinjectors, and other delivery systems.

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Episode Transcript

Tom von Gunden, Chief Editor, Drug Delivery Leader:

Welcome to another episode of Supplier Horizons, the series in which we hear from suppliers and service providers to the drug delivery industry about innovations and advancements. My name is Tom von Gunden, Chief Editor of Drug Delivery Leader, and for today's conversation, I am joined by Asmita Khanolkar, Senior Director of Pharma Services at contract manufacturer SMC Ltd.

Welcome, Asmita.

Asmita Khanolkar, Senior Director of Pharma Services, SMC Ltd:

It is great to be here talking about drug delivery and combination products. It should be a fun, exciting talk today.

I'm sure it will be. And so, to launch into the landscape of what's out there in terms of drug delivery and combination products, from your perspective, can you talk a little bit about what you see as you look out over the landscape of patient needs and therapeutic areas that might be good targets for innovations and advancements in delivery?

Absolutely, Tom. So, the trends that we see today obviously are moving towards in-home care. So, hospital-to-home seems like the ongoing theme for decentralizing, moving from using hospitals towards home treatment. And, as we look at that, it becomes imperative to really look at patient-centric solutions towards self-administration.

And, with that in mind, from a patient perspective, for their healthcare management, their treatment management, these things become important — from use of the therapy, to how they feel about the therapy, to adoption of the therapy. And based on all those things, there are many areas that come into play for innovation. I'm going to divide it into two areas: one from the pharma side of things and then one from the drug side of things.

Pharma companies are working towards getting the treatments to home [use] by moving to different formulations, from intravenous to subcutaneous, especially. In biologics we see that trend, and that is a big change from a perspective of, how do you now come up with these highly concentrated doses and large volumes to be delivered in the home setting to a patient? That's what they are working towards.

[Pharma companies are] also looking at new developments in manufacturing and storage of the drug. And from a delivery perspective, we are looking at [the] device side of things, as well, from a patient [perspective]. Although, these are complex formulations and require complex handling from manufacturing to storage. But also, on the delivery side, there is [a] requirement for patient-centric products ― devices that help them and are able to deliver these complex formulations in a very easy, simple setting so they can have adherence to the therapy and it is actually a therapy that works for them. So, from [the pharma] side, I think there are different avenues for innovation, not only from the formulation side, to creating formulations that actually meet the requirements for in-home treatment.

The other side of it is what we call the enabling technologies for device[s], so that we can then deliver these formulations, which are sometimes, frankly, beyond the capabilities of existing devices. So, innovations are required to be able to then deliver into the patients and [make the devices] easy to use and comply with, so [patients] can then get the full benefit of the therapy.

Okay, great. And thanks for painting the landscape. As you look across that landscape, are there any particular areas of urgency or priority? In other words, what's next? Where are the starting points, and why those starting points or the next steps in terms of innovation and advancement?

If we look at biotherapeutics in general, I think the challenges where the urgencies are coming [from include], as we transition, some of these formulations for in-home use. They are biologics [and] are very powerful, targeted drugs. But they are delivered in very high concentrations, large volumes, high viscosity.

So, as we start to talk about some of these large volumes and they need to be delivered, say, in a subcutaneous setting. The challenge there becomes, how do you develop these devices so it’s a successful therapy?

Historically, it was that the drug was developed first. It went through Phase 1, Phase 2, because, until then, people were pulling out the drug from a vial and using a syringe to deliver it. That was the trend. However, with some of these biologics, where they're delivered in these large volumes ― [and] large -sometimes have high viscosities, high concentrations, high dose[s] ― you need to bring in the device early on because you are not able to deliver them as simply as they could be with some of the other drugs previously.

So, the necessity and the urge are now for the device to be a part of the trial fairly sooner. So, it's early-on engagement with the device because now even clinical trials, like in cancer therapies, are being done at home.

So, when you are starting to do some early clinical trials at home, you want some of these enabling and device technologies early on, so it's administered correctly and then you are able to get good clinical results ― right from the beginning. So, the urgency is now. And because some of these solutions are not available right away, there is a time period for them to be developed and manufactured.

I think that need becomes more and more urgent to be able to be working on these [devices] and making [them] available for some of these therapies [that] are first-in-human, first-in-clinic. First-in-clinic: some of them are very novel therapies and [target] unmet needs that need to be addressed for the patients.

Yes. Great. And if you don't mind, I'd like to take it [the discussion] maybe a step or two down from the high-level challenge of things like large-molecule biologic therapies and how you get those into patients. Thinking about what you described in terms of working on the device early and thinking through the alignment of the formulation with the device, if you can take it down a step: What are some of those technical challenges and problems that need to be addressed or solved when it comes to that work of aligning the device with the formulation, especially in complex therapies?

Right. So, with delivering biologics, the challenge really is about having a platform or something that can deliver a variety of volumes, a variety of viscosities, a variety of needle sizes. Based on the formulation, the formulation behavior, how the formulation is delivered, and then how is it disseminated in the patient.

So, we have evolved through characterization studies where we look at the formulation, especially from a delivery point of view, to optimize delivery. So, what that means, then, is [that] we characterize the formulation for flow and delivery. So, we look at some of the viscosity behaviors: How does it behave under shear? What is the max viscosity? If it has some different behaviors like shear thinning or shear thickening, how does that affect ― how does the temperature affect ― the flow? Those are the kinds of things we try to study.

And then when it's delivered through a needle, what type of needle? What does the shear look [like] in there, as well as when it is delivered in the tissue? What is the tissue response? What happens with the dissemination? Dispersing of the drug under the skin, as well. So, all of these characterization things for delivery are especially important to be then able to figure out how they match with the formulation and if there are any tweaks that need to be made, both ways, whether it's on the device side [or] on the drug side, to be able to have optimized delivery. And that's one portion of it, which is the device capture [and] characterization with the formulation.

And then the other side of things, from there on, is also patient tolerability. What is the pain level? What is the tolerability? Is the patient able to take that much dose in that time? And is the dose able to disperse in that time, and does it meet the therapeutic efficacy?

There are so many unknowns and uncertainties at this time on some of these novel therapies that are coming out. So, it's really a marriage of understanding the formulation, the device, [and] the delivery, and making sure that the therapy is optimized for the patient and the patient benefits.

Great. So finally, as we look out on the horizon, following up on some of your comments about the patient experience[s] ―whatever they might be, whether these problems that are solved or challenges addressed or opportunities pursued, wherever we might arrive with those advancements and innovations: What might we hope for or anticipate that the patient experience would be like, both in terms of receiving drugs and therapies and, hopefully, having their lives improved or saved? And what might that look like if all [of the innovation] moves in the direction we hope that it will?

Right. So, I'm going to answer in two parts. The first one, I'm going to talk about some of the technical considerations and things that we are working on to provide some solutions in this area.

We're working on patient-centric autoinjectors. And the point of that is we're working on two sides of things: One is for biotherapeutics, which we're developing a platform for. It's called Bios because it is for the biotherapeutic section of most of the drugs for this. And here we have a platform that we can go from 1 mL to 2.25 mL to 5 mL within a platform, with the optimization of the volume so that we could have different volumes in there. We could have different needle sizes, and we can have different drugs, from 100 centipoise (cP) to 1,000 cP.

So, we are creating a platform, but it can be customized because one size does not fit all, as we know, for all of the therapies, all of the patients. And so, it gives many options to be able to handle these challenging formulations with large volume, high dose, high concentration, [and] high viscosities.

And there is this platform that you're able to adjust the power source; you're able to adjust the primary container and the needle size. So, you can have all of these offerings, and we have the technology to be able to overcome some of these challenges that we currently have today with being able to do large-volume and high-viscosity delivery. So, that's one of the things that we're working on to provide some options.

The second technology we're working on is for long-acting injectables. And although not as popular in biologics, there is a lot of development in this area because long-acting injectables drive patient compliance. [With] these, you don't have to take them as often. That's really the key here.

But some of these long-acting injectables are suspensions ― are two-phase. They can separate in storage if they're mixed in some sort of suspension. They can separate as solids and liquids. Over-the-shelf, when the patient is getting the autoinjector, this drug may have separated. So, what we have done in this enabling technology is have automated re-suspension. With that, when the patient uses the autoinjector, it’s automatically re-suspended if there is any separation in storage over time. So, the patient doesn't have to worry about any settling or anything like that happening. They would still get the complete therapy as desired.

So, these are some of the things that we're talking about.

And then on the second aspect of it: We're also looking from an ergonomic approach [at] the autoinjectors. How does it feel [to the patient] to use it? Sometimes the patients have issues with dexterity or vision. We're [also] working on the [autoinjector] window. The window that you can see is very large, so you can actually see how the drug is being delivered or, in [the] case of items where there's an end-of-dose click, audio as well as visual indication. So, it is a confirmed, yes, you've been delivered this much dose.

So those are the kinds of things that we're also looking at. Two-step, very easy-to-use autoinjectors and intuitive. There are all of these instructions that come with the use of any medical devices and autoinjectors. But intuitive is the word to be able to use for the patient. They don't have to keep reading everything and try to figure out how to use it and get trained on it over and over again.

And so, those are some of the things that we’re really working on to be able to make it a complete solution for the patients [to] not have to worry about the therapy as much, especially if it's chronic diseases and they have to take the medication day-in and day-out.

These are some of the things that they could do to have a much simpler life and not to have to worry about these things even though we're delivering complex drugs. But that's the least of their worry. They're getting the therapy as they need it at home.

Yes. Great. Well, that all sounds very promising from a patient perspective. And speaking of perspectives, I want to thank you, Asmita, for sharing yours on this episode of Supplier Horizons. I'd like to thank our audience for joining us, and we look forward to seeing you here next time.