Drug Substance Development

Hovione designs smarter, safer, and more efficient API processes—built on science, strengthened by data, enriched by experience, and ready for scale—helping you move faster, control complexity, and bring your product to market with confidence.

Turning complex chemistry into scalable success 

At Hovione, we make your molecule journey smoother, faster, and predictable. Our Process Chemistry Development team combines deep scientific expertise with advanced tools to design scalable, reliable, and high-quality API processes that deliver results from early development through commercial manufacturing.  

We take a data-driven, model-informed approach from day one, using data-rich experimentation, modelling, and Quality by Design to quickly understand your process and eliminate challenges during scale-up. This means faster decisions and a more efficient path for your project from early-stage development, ensuring reliable scale-up and faster market entry. 

Uncompromising safety  

Rigorous process safety studies underpin all our work, enabling safe execution of complex chemistries such as cryogenic, organometallic reactions, and hydrogenation. This disciplined approach allows us to engineer processes that remain safe, reliable, and effective at every scale and stage. 

Engineering solid‑state performance 

Our solid state and particle engineering expertise is a major differentiator. We design robust crystallization processes that deliver the right purity, particle size, and morphology while improving filtration and drying performance. When needed, spherical agglomeration technology enhances flowability, compressibility, and enables direct compression—streamlining your downstream steps.  

To keep development on track, we use advanced Process Analytical Technologies (PAT) tools such as Raman, Fourier transform infrared spectroscopy (FTIR), near-infrared spectroscopy (NIR), and real-time crystallization monitors. These tools provide immediate insight into reactions and critical steps, helping us optimize faster and ensure process robustness before reaching GMP scale.

Sustainability by design 

We are committed to sustainability by design and efficient chemistry, applying greener solvents, flow chemistry, and chemistry in water options — reducing cost, waste, and environmental impact. 

Contact us to learn how we are turning complex chemistry into scalable success.

 

 

Related files

Hovione - Drug Substance 2025.pdf
pdf (4.94 MB)
Download
PAT chemical processes.pdf
pdf (344.29 KB)
Download

Also in Drug Substance

Global Network

One partner to keep your molecule moving at pace by uniting R&D and Operations to navigate accelerated pathways.

Page

Drug Substance Manufacturing

Hovione combines highly adaptable manufacturing capabilities with a proven track record serving the most demanding customers in highly regulated markets—giving you the flexibility, reliability, and confidence needed to bring your product to market successfully.

Page

Drug Substance Sustainability

At Hovione, sustainability is embedded into every stage. Guided by sustainability-by-design and over 20 years of Green Chemistry expertise, we deliver cleaner, smarter, and more efficient solutions - helping you reduce environmental impact, meet regulatory expectations, and improve process performance.

Page

Drug Substance Integrated Offering

Hovione’s industry-leading particle science and tableting capabilities accelerate your path to commercialization by seamlessly bridging Drug Substance to Drug Product at a single site through a single interface-one project, one team approach.

Page