The recent introduction of numerous biologics and biosimilars and their corresponding advanced delivery specifications required have quickly created a new segment in the drug delivery technologies market in recent years.
This sector, often recognised as the combination product device technologies market, have stimulated the need to amend and combine various existing regulatory guidelines, understand new patient usage needs and advancement in innovative device designs.
Furthermore, biopharmaceutical companies now have to work even closer with device manufacturing partners to ensure the final device-drug combination products are not only compliant and meets patient needs but are innovative enough to be market competitive. As a result, it’s impeccable that all aspects of related quality and compliance of the final product is considered from as early as design stages all the way through to final assembly and packaging.
SHL recognises the importance of this topic and discusses it in more details in an article titled ‘Auto Injector Innovation’ under the quality and compliance section in a recent Pharmaceutical Manufacturing and Packing Sourcer’s (PMPS) issue.
Auto injector innovation
Growing demand for self-administration devices such as auto injectors and pen injectors is leading to ever-more innovative designs. But in the battle to stay competitive, manufacturing partnerships that can ensure quality, compliance and patient ease-of-use are key.
Driven by the efficacy and immunogenic natures of large molecule biological medicines, the growth of biologics and biosimilars has been evident in recent years, and continues to play a major role in the pipelines of biopharma companies and their acquisition strategies.
As the need for injectable delivery solutions for use with these large molecule biologics increases, the trend for self-administration devices is showing significant growth. Indeed, the demand for devices such as auto injectors and pen injectors has not only increased but is evolving. There is now a need for device designs to be even more innovative, while also adhering to applicable quality and compliance guidelines and, most importantly, patient needs.
As a result, it is paramount for combination product manufacturers to have a thorough understanding of established regulations – as well as to introduce technological and industrial device design innovations – to maintain market competitiveness through higher patient acceptance and compliance.
FDA combination product definitions
The US Food and Drug Administration (FDA) defines a ‘combination product’ as a medical product that consists of two or more components with any combination of drug/device, biologics/device, drug/biologic, drug/device/biologic, and so on, that together makes a single combined medical product through design, packaging or labelling.
There are four main categories: single entity combination product; co-packaged combination product; cross-labelled combination product; and cross-labelled combination product with an approved product. Auto injectors and pen injectors are considered as single entity combination products, as they are products comprising two or more regulated components (for example, drug/device and biologic/device) that are physically, chemically, or otherwise combined or mixed, and produced as single entities.
Although the method of collaboration for every auto injector or pen injector project may differ, it is common for biopharma companies to work with a primary container partner to provide the prefilled syringe or cartridge inside the device, and with a secondary packaging partner to design and manufacture the device constituent. Each of these constituent parts is subject to their corresponding current good manufacturing practice (cGMP) regulations before and after they are combined.
It is vital that the biopharma companies, which will market and distribute the final combination product, make certain that their chosen partners are also well-informed about the latest compliance guidelines and consider them at all stages of development.
However, in addition to regulatory compliance, the ultimate goal for biopharma companies is to market a product that enhances patient compliance through innovative device designs that provide dose accuracy, enhance usability and improve overall safety.
This is where the right device manufacturer partner can play a critical role, by not only comprehending and integrating into the device design the injection requirements inputted by the biopharma company (taking into account possible issues the primary container may have when the constituents combine), but also innovating within the sphere of applicable quality and compliance.