Drug delivery manufacturing evolves to keep up with intricate therapies
Drug delivery systems are imperative for providing a patient a therapy that can be administered efficiently, effectively, and easily. With the industry providing more complex treatments, the manufacturing of drug delivery systems has adjusted providing transdermal, subcutaneous, and injectable formulations to patients.
As the US Food and Drug Administration (FDA) has increased its push for generic complex drugs, manufacturers have looked to guidelines to adapt systems to the lower cost therapies.
In-PharmaTechnologist (IPT) spoke with Graham Reynolds (GR), VP of strategic partnerships and business development at West Pharma, about some of the ways in which the industry has adapted delivery systems to fit the changing needs of the industry. West Pharma is a global manufacturer for advanced, integrated containment and delivery systems.
IPT: What are some of the unique intricacies of manufacturing drug delivery devices?
GR: Manufacturing a drug that might be more viscous or might be higher in concentration obviously has manufacturing challenges to the pharma company that they have to consider; for example, how you handle a more viscous drug – you also have to put that drug into a container system that may not be the norm or the standard.
Many self-injected drugs are put into a 1 ml syringe, when you have to deliver almost 4 ml, the typical container isn’t appropriate. So, we developed a larger container that has to be filled. But then, to help our customers, we have to make sure we can offer them not just a container and a device but a filling solution.
IPT: What are some things to consider when deciding upon a drug delivery system?
GR: Drug delivery relies on four key elements. It starts with the molecule, and there are thousands of new molecules in development. You then question: what’s the container system? Should it go into a vial? Should it go into a syringe? An IV bag? So, thinking about the way that drug needs to be delivered, determines, in a very early stage, what type of container system it goes in.
The next level is the delivery device. For instance, if someone has to take that medicine, once a week at home, then you want it to be in a delivery device that a patient could use easily – that’s when you think about an auto-injector, for larger volumes a wearable, etc.
The final element is the patient itself. You could have the best drug, in the best container, in the best device, but if the patient says I’m really not comfortable giving myself an injection or a patient doesn’t do it when and how they should, then that drug is basically ineffective.
Those four elements: the molecules, container, device, and patient itself, all need to be considered to make a drug delivery system effective.
IPT: What are some difficulties of a combination product? How can they be mitigated?
GR: Making an injection device that is integrated with a drug, now becomes a combination product, which is subject to a lot of different testing and regulation to make sure all those things work together well; to give a safe and effective dose.
Historically, a customer may have been dealing with multiple different partners: one for the rubber, one for the glass vial, one to fill it, one to make the device, and one to put the thing together.
What we find is that if we can do all of that for a customer – to be a one-stop-shop that has value because we look at it as a system rather than as individual components. If there were any issues then it becomes a system issue rather than people pointing fingers.
IPT: What makes a delivery system more intricate?
GR: A drug is really only effective if it’s contained and delivered in the right way. A lot of our customers are working on the drug molecule and the science behind it, with the advent of new molecules and new innovations, they really have to be matched by enhancements in the way those drugs are contained and delivered.
As drugs get more complicated, they tend to react with chemicals that might be extracted from the container system. They might react adversely with particles or lubricants that might be used in a syringe system. Also, as drugs get more complicated, they often get bigger from a molecular perspective. When the size of these molecules get larger, it means that what might have been a 0.5 ml dose goes to a 1mL dose goes to a 3 ml dose, and ultimately a 10 ml dose as those drugs get more complicated.
IPT: There has been a push for access to complex generics, when it comes to making these generics in a delivery system what are some challenges to that?
GR: If you think about biologics, there are a whole set of challenges around reproducing the drug in an equivalent way. If you’re dealing with small-molecule generics, there’s a formula and there’s a method of production, where you can make a copy of that product.
To develop a drug and prove equivalency is really important. If that drug from the innovator is provided to patients in a particular delivery format, like an auto-injector or self-injection device, then typically the biosimilar company also needs to provide that to the patient in a very similar way.
You want to be able to use the drug [if you switched to generic or biosimilar] effectively, you don’t want something that’s more complicated, or maybe is so far away from what you’ve been used to.
The delivery device then becomes something that needs to be considered as much as the molecule itself. That just adds another complication to the drug developer.
IPT: What are some trends in drug delivery systems have you been seeing?
GR: I would say there is a general trend driven by a desire to move the point of care from a hospital to a home environment. So, if patients can treat themselves in a home environment then it saves the hassle of going into a hospital, it also reduces costs, and potentially improves adherence rates so people stay healthier.
In order for that to happen, then things like self-injection devices – the demand for those types of devices is growing because there are many studies that will show that for a patient, giving an injection with a device can be easier and more acceptable, than just a standard needle and syringe or vial. So, auto-injectors have become significant and then I think what we’re seeing is the next evolution of that is being driven by more complicated molecules but also a need for less frequent dosing that drives towards wearable injectors.
Wearable injector I’d say is anything more than a 1ml dose you’d typically get from an auto-injector. The idea of having a wearable is that it delivers a higher volume over a longer period of time, so its convenient for a patient – we’re seeing a lot of trending in that area.
Graham Reynolds currently serves as vice president of Strategic Partnerships and Business Development at West Pharma. He has held varying roles within the company, serving as vice president of different sectors for the past 17 years. Reynolds attended Trowbridge College where he studied Polymer Technology, the field in which he began his work at West Pharma 39 years prior.
