Bridging the Bench to Commercial Gap

In this interview, David Phasey from 3P innovation highlights why advanced technologies are critical to helping companies overcome the challenges associated with the development and manufacture of next-generation therapies.

An increasingly complex therapeutic pipeline is driving greater demand for innovative approaches to help overcome development and manufacturing challenges. To discuss the topic of how advanced technologies are being used to help with the development of next-generation therapies, The Pharma Navigator sat down with David Phasey, Innovation Director, 3P innovation.

Significantly More Diverse

TPN: Could you give an overview of the specific challenges pertaining to the development and manufacture of next-generation therapies?

Phasey: Next-generation therapies are significantly more diverse and complex than traditional pharmaceuticals, demanding entirely bespoke approaches to development, manufacturing, and delivery. A core challenge lies in the fact that the manufacturing route often doesn’t exist — it must be engineered from the ground up for each new therapy. This is especially true for cell therapies, where the product may be both manufactured and administered at the point of care, requiring a complete departure from conventional batch-based processes. Success hinges on the simultaneous development of the therapy, its delivery mechanism, and the manufacturing process — each of which is novel and interdependent. Most drug developers lack the in-house capabilities or established knowledge base to manage this level of complexity. For example, a recent solid dose injectable device designed to eliminate cold chain requirements required the co-development of a new formulation, device, and manufacturing method — developed by 3P innovation — highlighting the scale of innovation needed to bring next-gen therapies to market.

Criticality of Advanced Tech

TPN: How can advanced technologies help to overcome these development and manufacturing challenges?

Phasey: Advanced manufacturing technologies are critical to overcoming the unique challenges of next-generation therapies, enabling precision dosing, sensitive handling, and innovative delivery formats beyond the capabilities of traditional systems.

In a recent clinical trial for an inhaled gene therapy, a formulation requiring exceptional care was successfully filled into single-use inhalers using an advanced gravimetric powder filling technology developed by engineers at 3P innovation. Unlike conventional powder fillers, which risk damaging sensitive materials through compaction or shear forces, this technology enables gentle, controlled filling into single-use inhalers while preserving the integrity and efficacy of the therapy. This is a clear example of how advanced technologies can be leveraged to bridge the gap between formulation complexity and real-world delivery, ensuring next-gen therapies remain viable from manufacture to patient administration.

Not Yet Fully Ready

TPN: Are there any potential areas where advanced technologies are not yet suitable for use or where further development is needed?

Phasey: While advanced technologies such as sensing, instrumentation, and AI-driven data analytics hold immense promise for improving pharmaceutical manufacturing, particularly in enabling real-time release and rapid delivery of personalized medicines, they are not yet fully ready for widespread deployment.

These tools offer the potential to monitor product quality at an unprecedented level of detail, but current limitations lie in the validation and interpretation of the vast volumes of data they generate. Unlike traditional quality assurance processes, which rely on clearly defined, well-understood quality metrics directly linked to patient safety, the newer datasets (e.g. continuous environmental monitoring or complex process signatures) are not yet validated to the same degree. There is currently no robust framework to confirm that the insights derived from advanced analytics are definitively safe for patient use, especially in critical applications. Moreover, the volume and complexity of the data exceeds what can realistically be reviewed by human operators, making full automation and trust in AI-driven quality decisions a future goal rather than a present reality. Further development is needed to bridge the gap between in-process quality data and regulatory confidence for real time batch release.

A Demand for Flexibility

TPN: Why is flexibility particularly important for the increasingly complex development pipelines? How can advanced technologies help with this aspect?

Phasey: Flexibility is critical in modern development pipelines due to the growing prevalence of personalized and precision medicines, which require manufacturing processes that can adapt in real time to patient-specific variables.

Unlike traditional batch manufacturing, which is optimized for scale and uniformity, next-gen therapies often demand the ability to adjust formulation parameters, dosage, or even delivery mechanisms on a per-dose basis. Advanced manufacturing technologies enable this level of responsiveness by introducing modular, automated systems capable of dynamically adapting to varying inputs. These systems can precisely control key attributes, such as dose volume, composition, or device configuration — allowing manufacturers to tailor treatments without compromising speed, quality, or compliance. In essence, advanced technologies provide the agility needed to manage increasingly complex, patient-centric pipelines while maintaining manufacturing efficiency.

Accelerating Innovation

TPN: How are CDMOs utilizing advanced technologies to drive forward innovation in next-gen therapies in your opinion? Does more need to be done?

Phasey: CDMOs are increasingly leveraging advanced technologies to accelerate the development of next-generation therapies, particularly in the early-stage manufacture of complex formulations and ATMPs.

For example, advanced powder filling systems are enabling the precise handling of sensitive formulations in extremely small batch sizes — ideal for early research and feasibility studies. These same platforms can then be scaled alongside the client through clinical and commercial phases, supporting a seamless transition from concept to production. A similar trend is emerging in the ATMP space, where benchtop-scale technologies allow CDMOs to manufacture patient-specific therapies for clinical trials.

However, a significant gap remains for ATMPs when it comes to scalable, cost-effective platforms that bridge the bench-to-commercial transition. Current scale-up options are often large, capital-intensive, and inflexible — posing barriers to wider adoption and rapid deployment.

Photo by Sandra Grünewald on Unsplash