Manufacturing the route: oral and injectable drug delivery

Choosing a drug delivery format involves more than determining how a medicine will reach the patient. The decision also influences manufacturing requirements, the capabilities needed to bring a product to market and the options available to patients throughout treatment.

For pharmaceutical developers, considering these factors early may reduce the need for changes later in development. Speaking to EPR at CPHI Milan 2026, Jennifer Gattari of Pfizer CentreOne discussed why patient needs should be central to these decisions, particularly as the industry explores new delivery formats and ways to improve treatment convenience.

Products should be designed with the patient in mind from the very beginning”

“Products should be designed with the patient in mind from the very beginning,” she explains. “You need to consider what treatment will look like in the patient’s daily life. Will they need to take it every day or every week? Will they be able to administer it themselves, or will treatment require a visit to a healthcare setting or a lengthy infusion?”

These considerations can influence whether an oral or injectable format is most appropriate, as well as the device through which a medicine is administered. However, these options also have manufacturing implications. Oral solid dose products and sterile injectables typically require different facilities and capabilities, meaning that offering both formats is not simply a matter of adapting the same manufacturing process.

Gattari notes that developers should consider which delivery formats they intend to offer as they plan a product’s route to market. If patient convenience or self-administration becomes a priority later, changing the dosage or delivery format can require additional development work.

For sterile products, this may mean moving from a vial to a prefilled syringe or an autoinjector. While such changes may be achievable, considering them earlier may reduce the likelihood of redesign work after a product has been established.

Developing more sophisticated oral formulations

Oral solid dose development is evolving, with lower-dose formats and modified-release formulations offering new approaches to drug delivery. As Jennifer Gattari explains, long-acting formulations could reduce dosing frequency, while technologies such as laser drilling may support controlled release in certain tablet designs.

The potential benefit for patients is a treatment regimen that is easier to manage. Reducing dosing frequency may be particularly valuable for people who otherwise need to take medicines multiple times a day, although the suitability of a longer-acting formulation depends on the drug and its therapeutic requirements.

These developments illustrate how formulation and manufacturing decisions can influence the practical use of a medicine, rather than focusing solely on the finished dosage form.

Meeting demand across delivery formats

Gattari notes that manufacturers may encounter different capacity considerations for oral products and sterile injectables. However, she expects both oral and injectable medicines to remain important parts of the pharmaceutical market.

Against this backdrop, CDMOs vary in the delivery formats they offer, with some specialising in sterile injectables and others focusing on solid oral dosage forms. Some pharmaceutical companies may consider the range of delivery formats available from manufacturing service providers, particularly when future product presentations or lifecycle needs are still evolving.

For CDMOs, this means keeping pace with the technologies customers need, being transparent about capacity and planning early enough to address potential constraints.

AI across the pharmaceutical supply chain

Beyond delivery formats, artificial intelligence (AI) was another prominent theme at CPHI Milan 2026. For CDMOs, AI could support areas including manufacturing operations, equipment qualification, packaging and demand forecasting. The opportunity is not simply to introduce new tools, but to use data more effectively to identify risks and improve decisions.

Gattari also sees opportunities to use data more effectively to address challenges earlier in development. This includes learning from previous outcomes to help teams identify risks earlier and avoid repeating mistakes. Across the wider pharmaceutical industry, data may also help inform clinical-trial planning and participant identification. These applications could help pharmaceutical companies and their manufacturing service providers make better-informed decisions across development and production.

If we apply these technologies thoughtfully, the ultimate benefit should be for the patient.”

For CDMOs, the impact will depend on how effectively AI can be applied to specific processes and challenges. As Gattari explains, “If we apply these technologies thoughtfully, the ultimate benefit should be for the patient.” Ultimately, the value of these technologies will lie not simply in their adoption, but in how they can support better-informed decision-making and improvements in manufacturing processes, with the intended goal of benefiting patients.

Ultimately, whether the focus is on oral solid dose technologies, sterile injectables or emerging digital tools, manufacturing decisions need to account for both the requirements of the product and the needs of the patient. For developers and CDMOs alike, considering these factors early may support alignment between the manufacturing strategy, the product’s requirements, the developer’s long-term plans and the way patients will receive and use the medicine.