“Merck remains committed to pushing the boundaries of healthcare through cutting-edge research”

Alessandra Ambruosi, Director & Head of Solid Formulations & Pharm Materials R&D, Merck Life Science is an accomplished R&D leader with 17 years of experience in the pharmaceutical industry, specializing in solid dosage forms.

In this exclusive interaction, Alessandra Ambruosi shares the core mission behind the newly launched Merck’s Formulation & Technology Centre, key focus areas, latest technological trends and future outlook.

What is the core mission of Merck’s Formulation & Technology Center, and how does it align with Merck’s global life science strategy?

Merck’s newly launched Formulation & Technology Centre in Turbhe, Navi Mumbai, is a strategic step towards accelerating drug development and addressing complex pharmaceutical challenges across India, APAC, the Middle East, LATAM, and Africa.  This facility is built to streamline the formulation process and significantly reduce time-to-market for pharmaceutical products, which requires the right excipients, a well-established manufacturing process, and rigorous quality controls at every stage.

The centre is aligned with Merck’s global life science strategy of supporting the advancement of global healthcare through innovation, science, and technology. The formulation lab places a strong emphasis on customer-driven solutions and sustainable pharmaceutical development enhancing accessibility of pharmaceutical products through innovation and precision. Furthermore, it provides hands-on training, technical consulting, and customised solutions that are designed to tackle customer-centric challenges in formulation development, production scaling, and troubleshooting ensuring a tailored approach to evolving industry needs. The lab serves as a resource hub for the pharmaceutical community, to tackle real-world problems today, while preparing for tomorrow’s needs.

How is the centre positioning itself to address the evolving needs of the global pharmaceutical and biopharma markets?

To address the evolving needs of the global pharmaceutical and biopharma markets, the Merck’s Formulation & Technology Centre leverages latest advancements in excipient technology to support the development of high-quality formulations. The centre fosters long-term partnerships, giving clients the opportunity to co-develop solutions that contribute to the creation of next-generation therapies. 

To date, it has supported over 1,000 scientists from leading pharmaceutical companies including Sun Pharma, Dr. Reddy’s Lab, Hetero, Lupin, Slayback, Cipla, Emcure, Intas and Glenmark, reinforcing its role in fostering scientific progress and strengthening its partnerships across the generics and biosimilars landscape. Strategically established to serve growing market demands across India, APAC, the Middle East, LATAM, and Africa, the centre functions as a key resource hub for the pharmaceutical sector, addressing both current and emerging healthcare challenges. 

“The Merck’s Formulation & Technology Centre leverages latest advancements in excipient technology to support the development of high-quality formulations.”

What role does advanced technology play in accelerating the formulation process, and how does this influence time-to-market for pharmaceutical products?

The rapid evolution of the Indian pharmaceutical industry is largely fueled by  technological advancements and  therapeutic development. Merck’s Formulation & Technology Centre supports this growth with cutting-edge technologies such as spray drying, Wurster coating, and melt extrusion. It is also equipped with advanced research tools like Melt Prep®, NIR spectroscopy, particle size analyzers, rheometers, and predictive formulation tools, each designed to accelerate drug discovery and formulation development. These capabilities play a critical role in addressing patent-related challenges, developing novel excipients, and facilitating the faster introduction of high-quality generics to the market.  As a result, the time-to-market for new drugs is significantly shortened, ensuring faster and more efficient access to high-quality formulations that meet both regulatory and therapeutic standards.

How is the centre integrating advanced formulation platforms such as amorphous solid dispersions, lipid-based formulations, or nanoparticle systems?

The Center is equipped with cutting-edge technologies to meet the growing demand for advanced pharmaceutical formulations. It offers a range of amorphous solid dispersion (ASD) technologies, including solvent-free methods such as hot-melt extrusion, as well as solvent-based approaches like spray drying and carrier loading. In addition, the Center supports specialized techniques such as complexation, vacuum compression molding, and advanced analytical tools including Differential Scanning Calorimetry (DSC) and Near-Infrared (NIR) Spectroscopy to study interactions and compatibility among excipients.

Looking ahead, the Center plans to strategically expand its focus into novel drug delivery systems, particularly those based on lipid carriers and nanoparticulate technologies.

What kind of scientific expertise and multidisciplinary collaboration does the centre foster? How does it support continuous learning and innovation among its scientists and pharma manufacturers?

Merck’s Formulation & Technology Centre serves as a dynamic platform for collaborative research in drug formulation and delivery, acting as a knowledge hub that connects academia and industry. By bridging scientific innovation with practical application, the centre fosters the development of high-quality formulations that meet rigorous regulatory, therapeutic, and quality standards. The centre offers a collaborative platform where customers can explore novel excipients, understand their unique characteristics, and evaluate their quality for solid dosage forms. The facility offers access to advanced technologies for developing solid dosage forms, along with numerous strategies in the area of solubility enhancement. 

For academia and research institutions, the Centre offers specialized training programs, hands-on learning, and research support. It engages students through plant training to bridge theory and industry practice. Additionally, Merck’s experts also contribute to seminars and conferences, promoting continuous learning and knowledge exchange in the scientific community.

For pharmaceutical companies, the centre offers technical consulting, process optimization, and access to cutting-edge formulation technologies. This enables seamless transition from early-stage research to pilot-scale production and helps address complex formulation challenges, enhance drug delivery, and accelerate product development. 

By expanding its capabilities in India, Merck reaffirms its commitment to driving growth and fostering long-term engagement in the pharmaceutical sector, reflecting its belief in building strong, collaborative research partnerships.

What future technologies or formulation trends is the centre preparing for in the next 5–10 years?

Looking ahead, the centre is preparing for future technologies by emphasizing sustainable excipients, advanced drug delivery systems, and solubility enhancement strategies. With a vision to lead in sustainable pharmaceutical solutions, Merck remains committed to pushing the boundaries of healthcare through cutting-edge research, technological advancements, and a strong focus on improving patient outcomes.

The Center may expand its capabilities to focus on novel drug delivery systems, emphasizing the development of both small and large molecule therapeutics. In alignment with evolving industry needs, the Center aims to support the advancement of delivery platforms for complex compounds, including biologics.

Future initiatives may also include the development of a wide range of dosage forms utilizing sustainable excipients, reinforcing a commitment to innovation and environmental responsibility in pharmaceutical formulation.

*This interview was first published in the June 2025 edition of BioVoice eMagazine.