Modularity in Injectables Manufacturing

In the drug delivery realm, injectable devices is a growing trend in the pharma and biopharmaceutical industry, attributed to treatments increasingly moving from the hospital to the home setting, as well as personalized medicines and biologics. As demand for injectables consistently rises, manufacturers seek solutions for flexibility and scalability.
 
Streamlining production practices for something as complex as injectables manufacturing is complicated business. Raffaele Pace, Engineering Vice President of Operations at Stevanato Group, a provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, discusses the trends, challenges for manufacturers, and a scenario best suited for production customization. –KB
 
Contract Pharma: What are some of the trends driving growth of injectable devices?
 
Raffaele Pace: The parenteral pharmaceuticals landscape is inherently diverse, as such, one injectable device most certainly does not fit all. Several factors are contributing to growth in this sector. Treatments are increasingly moving from the hospital to the home setting, saving costs for healthcare providers and increasing patient comfort. This trend was exacerbated by the COVID-19 pandemic, when hospital treatments became high-risk environments for patients.
 
Overall, the pharma industry has seen a steadily-growing trend, with demand for injectables consistently rising. This can be attributed to the increase in chronic diseases that often require consistent self-administration to ensure proper treatment.
 
Additionally, the growing niche of targeted small batch and even personalized medicines, including oncology formulations and certain biologics, often leverage self-administration injectables.
 
The need for user-friendly injectable devices is clear. As such, it is not surprising that pen devices and auto-injectors have become exceedingly popular, as they deliver drugs efficiently while mitigating the typical risks associated with self-administration via syringes, such as incorrect dosing, device misuse, increased discomfort, and lack of patient adherence.
 
With the shift to end-user trends, to stay competitive pharma companies will need a “versatility-centric” approach to manufacturing optimization.  For efficiency, the process stretches all the way back to inception: the design, engineering, and production of the assembly line equipment tasked with manufacturing devices such as auto-injectors or pen injectors.
 
CP: What challenges do manufacturers face with injectable devices?  What does customization entail?
 
RP: Increasingly in this growing genre, custom-designed equipment, automation,
flexible and scalable manufacturing lines, and alternative manufacturing approaches will be critical to achieving timely, successful product launches. From an infrastructure investment standpoint, more customized medicines delivered via a broader array of injection devices means a premium is placed on equipment flexibility and modularity.
 
Although many injector types have similar components, their designs vary significantly in terms of size, material, and shape. This is a major production challenge, especially for contract manufacturing organizations and their pharmaceutical customers. The variety of shapes, sizes, components, configurations, and other variables are too exponential to calculate.
 
Like the pen injectors and auto-injectors themselves, the equipment-centric solution to this problem is multifaceted. To keep up with the needs of modern combination products, assembly machinery needs to check a number of boxes.
 
Foremost, is fast format changeover, which allows manufacturers to conveniently handle different formats (pens with variations) and save on downtime, and next is flexibility and scalability.
 
CP: How can manufactures address the needs?
 
RP: Flexible equipment is key to enabling manufacturers to accommodate production variations, or even handle different devices on the same line, eliminating the need for an entirely separate line configuration. Also, it allows reduced CAPEX investments and to achieve shorter time to market. To accommodate planned or sudden scale-up processes, the equipment should be scalable and “future-proof,” designed in a manner that allows additional modules to meet increased volumes.
 
Another factor is automation. Injectables manufacturing increasingly involves a push-pull in which, while lower commercial production volumes are commonly required, manufacturers also must be capable of efficiently switching gears to more far-reaching, wider-scale production. Even though batches are usually smaller, automating certain processes can reduce human intervention and further decrease production downtime. For example, tool-free changeover.
 
In both cases, the ability to pivot is where automation and robotics come into play. Automation becomes valuable for reliability, precision, repeatability, and process optimization. The goal is to incorporate these elements at the beginning of the development process, allowing for flexibility to test multiple solutions at a low scale of production and, as the process evolves, have an “automation foundation” in place to increase output. The more and the earlier a manufacturer can automate, the more efficient the ramp-up process is likely to progress.
 
This initiative allows companies to pre-configure many elements of an automation line, as part of “preplanning” the process for progressing projects from early R&D through clinical trials and production, regardless of batch size.
 
From an equipment aspect, modularity is the primary prerequisite for flexibility and scalability.