Changing the game: The dynamics and complexities of switching delivery formats for sterile injectable therapies 24th October 2023
By Christy Eatmon, Global SME, sterile drug products, pharma services, Thermo Fisher Scientific
The injectable drug market is booming, expected to hit a staggering market value of $762.48 billion market value by 2028 from $52.88 billion in 20231.
With the surge in demand for vaccines and treatments for chronic diseases, the pharmaceutical industry faces a parallel increase in demand for primary packaging. As suppliers grapple with rising costs and supply constraints, shifting delivery formats of injectable therapies is emerging as a viable strategy for better lifecycle management.
Why change delivery formats?
Switching delivery formats is not merely a logistical exercise; it can bring a drug to market faster, make it usable in diverse settings, optimise costs and make administration easier for patients. One significant shift is from bulk glass vials to pre-filled syringes. This change enhances patient safety by eliminating dosing errors, streamlines the delivery process and allows for greater convenience. A pre-filled syringe can be administered directly, while a vial involves several preparatory steps, each introducing potential errors.
Types of presentation shifts
Common presentation changes involve shifting from ampoules to liquid-filled vials, lyophilised vials or pre-filled syringes and cartridges. One notable trend is moving from frozen liquid vials stored at -70°C to liquid vials stored at 2°C to 8°C. This shift significantly reduces the storage and distribution costs. Another change involves freeze-drying or lyophilisation, which is particularly beneficial for biological products requiring long-term storage.
The complexity of switching
Shifting delivery formats is far from straightforward. It requires a multidisciplinary approach, involving departments from product development to regulatory teams. Several factors like the physicochemical properties of the molecule, interactions with device components and impacts on product stability and quality are critical to the transition. The molecule type, value of the product, long-term storage goals and regulatory paths are all essential considerations in choosing the optimal format.
- Material concerns: When switching, maintaining the quality of the drug substance is crucial. For instance, if shifting from a frozen liquid to a 5C liquid, the use of excipients like cryo-protectants must be carefully evaluated for their impact on product integrity.
- Timeline factors: The timing of the shift is also strategic. Stability and compatibility tests, often taking 6-12 months, need to be factored into the timeline. Generally, it’s advisable to have the product in its final presentation by Phase 3 of the clinical trials.
- Regulatory issues: Regulatory considerations are a major part of the transition. Requirements range from extractable studies to container closure integrity testing (CCIT). Each alteration triggers a set of regulatory considerations, necessitating a comprehensive strategy for a smooth approval pathway.
Changing the delivery format of an injectable therapy is a complex, but increasingly essential strategy for suppliers. Whether motivated by patient-centricity or market competition, this transition can offer manifold benefits, from cost savings to improved patient outcomes.
However, this change is not without its challenges. Material, timeline, and regulatory considerations add layers of complexity that demand a holistic, collaborative approach. When carefully managed, switching delivery formats not only enhances the return on investment for companies, but also significantly benefits patients and healthcare providers. Thus, in a market marked by relentless growth and dynamic needs, the ability to adapt delivery formats could well be a game-changer for the pharmaceutical industry.
- Injectable drugs market size & share analysis – Growth trends & forecasts (2023—2028).” Morder Intelligence. https://www.mordorintelligence.com/industry-reports/sterile-injectable-drugs-market