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Pharmaceutical Manufacturing and Packing Sourcer

Keep it Close

Monoclonal antibodies, peptides and many other types of biologic drugs have significant potential to redefine treatment methods, reduce healthcare costs and improve patient care for a range of chronic diseases. However, the molecular complexity of these high-value drugs has created a challenge for pharma companies seeking a subcutaneous delivery system that can administer a formulation with the right dose volume and viscosity over the right duration period.

When the aggregated concentration of a liquid becomes too high, potential drug safety and efficacy risks may be created. Alternatively, when a large volume dose is injected over too short a period of time, the subcutaneous layer’s capacity to absorb the drug can be compromised. Patients may experience increased discomfort, tissue distortion, edema, irritation or redness when a large dose volume is administered too quickly. When a user attempts to inject a dose over a period of more than 15 seconds, there can also be a natural loss of attention and a likely change in angularity which may affect therapy compliance.

New Solutions

For biologics that can be formulated in a liquid dose volume of 1mL or less with a satisfactory viscosity level, subcutaneous administration in a disposable hand-held device such as a prefilled syringe or auto-injector has traditionally represented the most attractive delivery option.

However, an estimated 15-20 per cent of biologics in clinical development are expected to have a final concentration where such hand-held devices become unfeasible. Instead, many pharma and biotech companies now recognise that these molecules are better suited to delivery in disposable devices that can be worn or attached onto the body during an extended period of subcutaneous administration (see Figure 1). Known as wearable injectors, or patch pumps, this new class of device represents one of the most significant and fastest-growing areas of the medical device market. By some estimates, the global market for wearable injectors is poised to generate total sales of approximately $3 billion within five to seven years.

Technology Pathway

Wearable injectors should not be confused with insulin pumps, which are often reusable and slowly deliver up to 3mL of a drug over an extended period of time and have a sophisticated user interface. In contrast, wearable injectors are designed to inject a single measured dose of up to 30mL over a pre-programmed rate and duration. Insulin pump technology is also considered to be too complex and expensive to support the delivery of drugs requiring the administration of a standardised dose to the patient on a periodic basis, such as once every month. Due to the need to precisely deliver a dose at a variable rate, insulin pumps also warrant a higher level of regulatory scrutiny than wearable injectors.

While these injectors are primarily designed for use with molecules that have dose volumes greater than 1mL, they are also suitable for low-dose therapies where factors such as viscosity may require subcutaneous injection for durations of 30 seconds or more.

Many pharma companies now recognise wearable injectors as the most appropriate technology pathway to enable or enhance the delivery of a multitude of biologic therapies within their drug portfolio. Auto-immune, central nervous system, cardiovascular and infectious diseases, as well as oncology, represent a handful of the therapy areas where drugs are now being targeted for use with wearable injectors. Due to this diversity of therapy areas and patient populations, many pharma companies are seeking to adopt a platform-based strategy for wearable injectors that will provide the flexibility to address the specific needs of each target molecule across their portfolio.

Device Specifications

Based upon target specifications issued by pharma companies seeking a platform technology for wearable injectors, there are a few criteria that can be considered as standard requirements, including:

● Delivery rate: bolus, basal or variable rate injection of a single dose
● Delivery duration: delivers the full contents over a preset time from seconds to hours
● Dose volume: up to 15mL (in some cases this may be higher)
● Viscosity: up to 100cP
● Primary container: utilises standard materials in the primary drug container and fluid path
● Filling: compatible with conventional filling processes
● Needle/cannula: automatic insertion of sterile needle/ cannula and withdrawal
● Electronic user interface: visual and audible indicators regarding injection status
● Drug visibility: ability for the user to view the drug prior to, and during, injection

Potential Benefits

There are many market opportunities for pharma companies that are able to bring their large dose volume or long-duration delivery biologics to market in a wearable injector format. These devices can bring benefits for:

● Clinical development: allows for pipeline drugs to be developed in larger dose volumes to avoid potential aggregation and patient discomfort risks associated with high concentrations
● Lifecycle management: transition-approved drugs currently indicated for intravenous infusion into a subcutaneous administration format, suitable for patient self-injection
● Brand differentiation: generates significant brand differentiation against competing drugs, or potentially expands the number of indications where it may be prescribed

For patients, prescribers and payors, the potential benefits provided by wearable injector technologies are virtually unlimited. These devices have the ability to allow a patient to intuitively deliver a drug at any time or place of their choice. This freedom creates an opportunity for the patient to live as close to a normal life as possible during the period of dose delivery. With the device being worn underneath clothing, a patient can conceivably administer the dose with complete anonymity across a range of environments, including home, work, a café or the gym (see Figure 2, page 22). When dosing is complete, they simply peel off the device for convenient disposal.

These factors can not only help to improve quality of life and generate greater independence for the patient, but potentially optimise therapy convenience and compliance. Payors can leverage these opportunities to transition healthcare from the healthcare facility to wherever the patient is, to dramatically reduce treatment-related costs. Brought together, such benefits create significant opportunities for a pharma company to drive preference rates towards their therapy, to build or protect market share.

Choosing the Right Technology

Various wearable injector technologies are either available or in the process of being developed by device manufacturers. There are some significant differences between each of these proprietary technologies. For example, the primary packaging container can range from a standard glass cartridge to less conventional options such as a collapsible membrane. Some of the devices may require primary container materials such as CZ resin and coated elastomers, whereas others utilise standard borosilicate type 1 glass and pharmaceutical-grade elastomers.

The method of filling a wearable injector with a measured dose of drug can vary widely among competing technologies. Certain devices are supplied ready for integration into standard syringe filling lines, whereas others require special filling processes. Another significant difference can be the method of sterilisation, as some enable decontamination of only the drug and human contacting surfaces, and others require terminal sterilisation.

Patient Usability

Competing wearable injector technologies also have different steps of use for the patient. One major point of differentiation is between devices that are supplied prefilled, pre-assembled and ready-for-injection, and others that first require the user to insert a cartridge into the delivery system. Human factor studies have highlighted a strong user preference for devices that are pre-packaged and minimise steps of use.

Brought together, the ideal wearable injector technology for a pharma or biotech company should deliver simplicity and flexibility for the customer, the molecule and the target patient population. By being simple to use, a wearable injector should provide the most intuitive, effective and confident user experience.

By being simple to customise, it should provide a customer with the flexibility to address the specific operational, sales, marketing and therapeutic needs of a broad portfolio of molecules (see Figure 3, page 24). And by being simple to take to market, it should enable seamless integration with approved manufacturing methods and materials, to facilitate rapid development and approval of the drug product.

System Case Study

One example of such a device platform, ReadyToGo™ wearable injectors, utilise standard materials in the primary drug container and are compatible with standard filling processes and equipment. They can be programmed to deliver a measured dose of up to 30mL in volume and up to 100cP in viscosity over seconds, minutes or hours at a constant or variable rate based upon the specific requirements of the pharma customer, their drug and the target patient. The system maintains sterility of all drug contacting and fluid path components without requiring full terminal device sterilisation.

The wearable device requires only three simple steps of use (peel, stick and click) and features a compact, ergonomic design. After automatically inserting a soft cannula for injection, the needle is automatically retracted for patient comfort and to eliminate sharps hazards. Electronic and mechanical visual and audio indicators can provide user confidence and under-clothing awareness, while a large window provides 180-degree visibility to the dose during all stages of use.

Additional safety factors include:

● Sharps safety: no exposed sharps at any point during device usage
● Activation safety: on-body interlock mechanism prevents accidental activation from occurring
● Therapy delivery safety: visual and audible status indicators provide status and keep the user informed
● Attachment and removal safety: secure adhesion to the skin prevents accidental detachment of the device
● Reuse prevention safety: the devices cannot be disassembled non-destructively, reset or reloaded
● Structural safety: the devices can withstand mechanical forces and environmental conditions that well exceed those during typical usage and shipping

In order to produce the optimal product customisations in the shortest possible timelines, the wearable injector platform has been designed with the flexibility to address specific customer, drug and patient needs for a wide variety of target molecules.

Hyper Growth

The wearable injector market represents one of the most important new sectors for the delivery of injectable drugs, including biologics. With many pharma companies having several molecules in the clinical pipelines being targeted for use in a wearable injector format, the device sector is poised for hyper-rates of growth. Within the next 10 years, it is expected that a wearable injector will be as commonplace in healthcare as a prefilled syringe.

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Alan Shortall is the Chief Executive Officer of Unilife Corporation, a US-based company engaged in the design, development, production and supply of injectable drug delivery systems. Since founding Unilife in 2002, Alan has guided the emergence of the company into a provider of innovative, differentiated and customisable devices that can enhance and enable injectable therapies.
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