Pointed Debate - Industry experts discuss the benefits and challenges of self-administration of injectable therapies. - BioPharm International


Pointed Debate
Industry experts discuss the benefits and challenges of self-administration of injectable therapies.

BioPharm International
pp. 42-48

Potter (Glide): Autoinjectors and pen-injectors have been designed for self-administration. These technologies are widely used, work very well, and are far easier to use and more convenient for patients than a standard needle and syringe. However, they still use a needle, which brings about issues related to needle reuse, needle disposal and needle phobia. In addition, many drugs that have to be injected are not very stable in a liquid formulation. Some biologics are stored in a powdered form to provide better stability, but they need reconstituted prior to injection, which adds to costs and treatment complexity. Liquid jet injectors avoid the issues with needles, but still incorporate a liquid formulation. They are also very expensive and have not achieved significant market traction.

None of the technologies mentioned really provide a simple way to inject a controlledrelease formulation. Typically, a controlledrelease formulation comprises polymer microspheres in a solution, but because of the issues of needle clogging these expensive products are normally injected by specially trained healthcare professionals. Other injection technologies, such as solid dose injectors and microneedle patches, are in development, but they are not yet ready for routine patient use.

Sadowski (Antares): The key to considering self-administration technologies is to focus on the patient. Our company, for example, is not committed to any particular injection technology type. Companies should design the technical solution that best fits the circumstances in a given therapeutic application. In particular, it's important to consider the patient's needs and limitations in the target disease condition, and then to look at how best to apply technology to make the patients' self-injection experience most acceptable and successful.

BioPharm: What extra steps do companies need to take to have a drug approved for use in a self-administrative form?

Kaufman (SHL Group): Generally, a biological drug will need to be first approved as an independent drug, regardless of whether or not it is to be used in a self-administrative form. For the device constituent of a combination product, the medical device manufacturer will generally support biopharmaceutical companies by filing a master access file and/or 510K to help with the customer's submission process.

Self-administered biological drugs can generally be placed inside a primary container such as a prefilled syringe or cartridge, which will then reside in a device that possesses the mechanical system to perform the injection. The two together are a drug/device combination product that, although not yet official, has been identified by FDA as an area that requires regulatory guidance. Companies that wish to introduce a drug in a self-administrative form will need to start regulatory planning at a very early stage to ensure that approval times do not become a potential bottleneck to a successful global launch.

Novara (BD): The complexity of clinical development and the regulatory process is increasing, and companies must take every appropriate step to ensure that their products are in full compliance. In addition, companies have to bear in mind the lead times for regulatory processes.

Potter (Glide): Any pharmaceutical product in development must undergo clinical trials. In addition, a product that is to be self-administered needs to undergo trials with volunteers and patients to ensure that the delivery system can be safely used by different patient groups in a non-clinical setting. Some of these trials may be userhandling trials, with no drug involved, just to demonstrate that the volunteer can safely use the delivery system. These trials are far simpler and cheaper to conduct than active drug trials. Once trials have been carried out for a first product, then further trials to investigate the handling and use of the delivery technology may only be required if the product is for a different patient group (e.g., elderly patients or patients with rheumatoid arthritis who may struggle to handle a delivery device).

BioPharm: How are designers and manufacturers of selfadministration devices approaching the challenges of ensuring sterility and accurate dosing outside of healthcare settings?

Kaufman (SHL Group): Accurate dosing is achieved through specially designed delivery mechanisms, rigorous testing, and precise manufacturing. For example, in a mechanical device, highly accurate dosing can be achieved using the appropriate spring technologies. Sterility is ensured again by designing a suitable device for the primary container selected by the biopharmaceutical partner; for example, a prefilled syringe that is assembled into an autoinjector under controlled procedures in line with related regulations and standards.

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