Rise of Enabling Technologies in Pharmaceutical Formulation Development and Manufacturing
Kasturi Pawar , Director, Formulation Development, Exelixis, Inc
Kasturi Pawar is a leading pharmaceutical scientist with a PhD in pharmaceutical sciences. She has significantly contributed to the field of pharmaceutics. Her research and experience have been focused on formulation development, drug delivery, and clinical supply chain. Currently working as a Director in Formulation Development at Exelixis, Inc., she holds several publications and patents on drug delivery using conventional solid oral as well as enabled formulations such as nanoemulsions, microneedles, and iontophoresis. Her work has been widely cited and recognised across the pharmaceutical industry and scientific community.
Abstract
Enabling technologies are reshaping drug formulation development by integrating advanced polymer technology, nanotechnology, and continuous manufacturing. These innovations enhance solubility, stability, and bioavailability while accelerating optimisation and regulatory approval. Together, they enable patient-centric, efficient, and precise formulation strategies, marking a paradigm shift in pharmaceutical research and therapeutic delivery.
1. The pharmaceutical industry is witnessing a paradigm shift in formulation development. How do you define the role of enabling technologies in this transformation?
Enabling technologies are transforming formulation development by helping us overcome key challenges like poor solubility and stability. Tools such as amorphous solid dispersions, nanotechnology, and lipid-based systems allow more molecules to progress from discovery into the clinic. They also support patient-centric dosage forms and, when integrated with digital tools and continuous manufacturing, make development faster, more reliable, and better aligned with personalized medicine.
2. Polymer technology has become central to modern formulations. What breakthroughs in polymer science are most influential in improving drug solubility and stability?
Polymer science has really reshaped modern formulations. The biggest breakthroughs have been in polymers for amorphous solid dispersions, like HPMCAS and copovidone, which stabilise drugs in their amorphous form and prevent crystallisation. We’ve also seen advances in pH-responsive polymers that enable site-specific release, and smart copolymers that improve solubility for poorly water-soluble drugs. More recently, polymers have become central to stabilising lipid nanoparticles for RNA therapeutics. Altogether, these innovations not only improve solubility and stability but also expand various kinds of molecules we can successfully bring forward into development.
3. Nanotechnology is often described as a game-changer. How are nanocarriers and nanoscale delivery systems reshaping bioavailability and targeted drug delivery?
Nanotechnology has truly been a game-changer because nanocarriers improve both solubility and precision. Nanocrystals and polymeric nanoparticles enhance the dissolution of poorly water-soluble drugs, while lipid-based systems like liposomes and lipid nanoparticles improve bioavailability and protect sensitive payloads. Importantly, nanoscale delivery allows for surface modifications—such as PEGylation or ligand targeting—that guide drugs to specific tissues or even tumor sites, reducing off-target effects and toxicity. This means nanotechnology not only improves bioavailability but also enables targeted and controlled delivery, which is critical for modern therapeutics including oncology drugs and RNA-based medicines.
4. Continuous manufacturing is steadily replacing traditional batch processes. What are the key operational and regulatory drivers accelerating this shift?
Continuous manufacturing is gaining momentum because it offers operational advantages like shorter development timelines, better process control, and real-time monitoring through process analytical technologies. It reduces variability, increases efficiency, and makes scaling more seamless compared to batch processes. From a regulatory standpoint, both the FDA and EMA have strongly encouraged the shift, by publishing guidance and providing expedited review pathways for continuous systems. Regulators see it as a pathway to improve product quality, ensure supply chain resilience, and lower the risk of drug shortages. The combination of efficiency gains, consistent quality, and regulatory support is accelerating adoption of continuous manufacturing across the industry.
5. How do enabling technologies collectively contribute to reducing time-to-market for novel drug formulations?
Enabling technologies shorten time-to-market by addressing the major bottlenecks in formulation early. For example, solubility-enhancing technologies like amorphous solid dispersions or nanocarriers help “rescue” poorly soluble compounds that would otherwise face challenges in solubilising it. Predictive modelling and polymer screening allow faster selection of viable formulations, while process innovations such as continuous manufacturing and real-time analytics accelerate scale-up and reduce trial-and-error. Collectively, these technologies de-risk development, minimise reformulation late in the pipeline, and allow smoother regulatory interactions. Hence, promising molecules move more efficiently from discovery to patients.
6. With regulators becoming increasingly supportive of innovation, how are regulatory frameworks evolving to accommodate technologies like nanotechnology and continuous processing?
Regulatory frameworks are evolving in step with innovation. Agencies like the FDA and EMA have issued dedicated guidance documents for nanotechnology-based products, focusing on characterisation, safety, and bioequivalence to ensure consistent evaluation. At the same time, they’re actively promoting continuous manufacturing by publishing technical guidance, offering expedited review pathways, and supporting real-time release testing with process analytical technology.
7. Patient-centric formulations are at the forefront today. How do these technologies allow for customised dosage forms and more precise therapeutic outcomes?
Patient-centric formulations are about tailoring therapies to individual needs rather than relying on a one-size-fits-all approach. Enabling technologies make this possible by providing flexible dosage design. For example, 3D printing and advanced polymer systems allow customisable tablets with adjustable drug loads and release profiles. Nanocarriers and lipid-based systems support targeted delivery, ensuring drugs act where they’re needed with fewer side effects. Orally disintegrating films and pediatric-friendly liquid dispersions improve adherence in specific populations. By integrating these innovations, we can deliver not just the right drug, but the right dose, in the right format, ultimately leading to more precise and effective therapeutic outcomes.
8. Integration of digital tools and automation is rising alongside enabling technologies. What role does data analytics and digitalisation play in optimising formulation strategies?
Digitalisation and data analytics are transforming formulation development by shifting it from trial-and-error to data-driven decision-making. Predictive modeling and AI/ML algorithms help screen excipients, polymers, and process parameters early, reducing failed experiments. Process analytical technology (PAT) and automation provide real-time monitoring, allowing immediate adjustments during manufacturing. Digital twins and simulation platforms accelerate scale-up by modeling how a formulation will behave at commercial scale before physical trials. Together, these tools reduce variability, improve efficiency, and enable more robust, patient-centric formulations to reach the market faster.
9. How can enabling technologies help address the challenge of poorly soluble APIs, which represent a significant portion of the drug pipeline?
Poorly soluble APIs are one of the biggest hurdles in modern pipelines, with more than 70 per cent of small molecules facing solubility issues. Enabling technologies directly address this challenge. Amorphous solid dispersions stabilise drugs in a high-energy amorphous state to boost dissolution. Lipid-based systems, like self-emulsifying formulations, enhance solubilisation and lymphatic uptake. Nanotechnology, including nanocrystals and polymeric nanoparticles, increases surface area and dissolution rates. Cyclodextrin complexes improve aqueous solubility and stability. By tailoring the approach to the molecule’s properties, these technologies unlock bioavailability, rescue compounds that might otherwise fail, and expand therapeutic options.
10. Continuous manufacturing promises efficiency, but what are the major adoption barriers for large pharmaceutical companies and smaller biotech firms?
Continuous manufacturing offers clear benefits, but adoption is not without barriers. For large pharma companies, the main challenge is legacy infrastructure—most facilities are built around batch processes, so shifting requires huge capital investment and organisational change. For smaller biotech firms, the barrier is often cost and expertise, since continuous systems demand advanced process understanding, automation, and regulatory know-how. Across the industry, there are also concerns about regulatory uncertainty in global markets, workforce training, and the need for robust real-time analytics to ensure quality. So while the promise is efficiency and quality, adoption requires overcoming both technical and economic hurdles.
11. In terms of safety and scalability, how do you ensure that nanotechnology-driven formulations meet industry-wide standards?
Ensuring safety and scalability in nanotechnology-driven formulations requires a combination of rigorous characterisation, process control, and regulatory alignment. On the safety side, detailed particle size distribution, surface chemistry, and stability studies are critical to assess toxicity and biodistribution. Industry relies on standardised assays, and ICH guidelines to evaluate immunogenicity and long-term effects. On scalability, reproducible manufacturing processes—often with continuous or modular systems—are combined with process analytical technology to ensure consistency at commercial scale. Regulators like the FDA and EMA have issued specific guidance for nanomedicines, so aligning with these frameworks and demonstrating quality by design is key to meeting industry-wide standards.
12. Many enabling technologies are cost-intensive. How can pharmaceutical companies balance innovation with affordability, especially in emerging markets?
Enabling technologies can be expensive, but there are ways to balance innovation with affordability. First, companies can apply a tiered strategy, where high-cost innovations like nanotechnology are prioritised for drugs with the highest unmet need or global blockbuster potential, while simpler, lower-cost solutions like cyclodextrin complexes or ASDs are used elsewhere. Second, platform technologies—such as lipid nanoparticles or continuous manufacturing—reduce long-term costs by being reusable across multiple products. Third, strategic partnerships with local manufacturers, technology transfer, and flexible licensing models can make advanced formulations more accessible in emerging markets. Ultimately, combining smart technology selection with scalable, cost-efficient processes helps align innovation with affordability.
13. Looking ahead, which emerging technologies or hybrid approaches do you believe will define the next decade of formulation development?
The next decade of formulation development will be shaped by hybrid approaches that combine material science, nanotechnology, and digital tools. We’re seeing growth in polymer–lipid hybrids that stabilise poorly soluble drugs, smart nanocarriers with targeting ligands for precision delivery, and 3D-printed dosage forms for personalized medicine. On the digital side, AI-driven formulation design and digital twins will allow predictive modeling of drug–excipient interactions and scale-up behavior, cutting down development time. Continuous manufacturing, integrated with real-time analytics, will provide consistency and speed. Together, these emerging and hybrid approaches will enable more patient-centric, efficient, and flexible drug development pipelines.
14. Finally, if you were to summarise the impact of enabling technologies in one phrase, how are they reshaping therapeutic delivery and the overall pharmaceutical landscape?
Enabling technologies are transforming therapeutic delivery by turning scientific complexity into practical, patient-centric solutions.
