Karen Flynn, President, Pharmaceutical Packaging Systems at West Pharmaceutical Services, recalls the trends that have impacted injectables in 2015, and provides an overview of emerging injectable trends for 2016.
Injectable devices are designed to make the drug administration process easier, more accurate, and, above all else, safer for patients. While focused on patient needs, manufacturers also have to employ efficient and cost-effective production to ensure market viability. Achieving this balance is not always easy, however, a number of trends in 2015 created tremendous upside for both patients and manufacturers, and a number of emerging trends should drive similar momentum in the coming year and beyond.
Trends that Impacted Injectables in 2015:
1. QbD
In the past year, there has been increased discussion and emphasis on using Quality by Design (QbD) as a methodology for generating a deeper product and process understanding in the injectables market. Interest in QbD principles originated in the past decade out of regulatory pressures and the industry’s ongoing focus on quality and efficiency in drug manufacturing.
Recently, QbD advanced through the entire supply chain with the understanding and requirement that all companies involved in the development, manufacturing, containment, and delivery of drugs adopt QbD principles when bringing new products to market. QbD principles can require a significant up-front investment, which can understandably lead some in the industry to initially shy away. That said, the investment delivers an improved, data-driven output that can lead to a superior product. Additionally, QbD initiatives also lead to a process that allows stakeholders to better understand risk and how to minimize it.
2. Supply Chain Risk
Typically, when examining supply chain risk, factors such as transportation, political climate, and global economics are considered. For obvious reasons, supply chain disruption can have an adverse impact in delivering needed pharmaceutical products, including packaging/delivery systems, to the end user. Because of this, we are now seeing increased discussion in the injectable sector around the origin of materials and the ability to quickly shift to another region should one be compromised by natural disasters or other natural irregularities that compromise safety. As risk management technologies continue to improve, pharmaceutical companies have greater insights into the probability that supply chain risks may occur and, in turn, allow the industry to react more quickly to avoid disruption.
3. Evolution of Combination Products
Self-administration and biologics have only increased the popularity of combination products, such as wearable auto-injector systems used for the management of chronic diseases. Biologics, which are primarily being administered through injections, have played a large part in the demand for combination products. Auto-injectors, wearables, and other new systems will only increase the already budding demand in the coming years.
Emerging Trends to Impact Injectable in 2016:
1. Flexible Manufacturing
Many pharmaceutical companies are looking for ways to institute adaptive filling techniques. Flexible manufacturing allows systems to be adjusted for a variety of dosage forms which, in turn, potentially reduces costs and space requirements. A primary driver of flexible manufacturing is the healthcare system’s ongoing shift to personalized medicine, leading to smaller quantities of drug products and more sophisticated therapies, such as biologics. Flexible manufacturing enables drug companies to quickly transition fill lines from vial format to cartridge to prefilled syringes, depending on the needs of the injectable medicine. Injectable drug delivery system manufacturers will be tasked with creating innovative methods to allow adaptive filling to occur. Although commercial utilization of flexible manufacturing is likely further down the road, some pharmaceutical companies have started to examine its utility around clinical trials, where smaller quantities are needed.
2. Continuous vs. Batch Manufacturing
To date, the pharmaceutical industry has been largely focused on manufacturing in batch quantities. The process is quite straight forward: make a certain number of batches, validate, and submit the data. However, this method is somewhat behind the curve when compared to other manufacturing operations, such as oil refining, steel casting, paper production, and natural gas processing. Expect pharma to begin to look away from a batched approach and explore continuous manufacturing in 2016, where product testing occurs during the production process using real-time analytics to identify and react to irregular trends. The result is an increase in quality and a higher level of confidence throughout the process.
Additionally, continuous manufacturing offers greater cost reduction because production doesn’t have to stop between each batch and it drastically reduces the amount of unusable end products. Although historically, this has been a bit of a challenge for pharma, the introduction of different techniques and process analytical technologies—part of which is driven by QbD approaches—is pushing the industry in this new, data-driven direction.
3. Biosimilars
2015 saw the first FDA-approved biosimilar, and this just the tip of the proverbial iceberg in the U.S. market. Biosimilars are several times cheaper to bring to market than biologics, and with several companies competing for the same biosimilar, the mechanism of administration can be a key differentiator. For injectable biosimilars currently in the pipeline, it will be important to examine drug delivery options that can improve the patient experience while ensuring, when possible, a delivery format that patients are currently familiar and comfortable with.
Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!
