The evolution of this growing demand and how at Angelini Pharma we can support it

👉 What trend do you see in the HPAPI Industry?

"HPAPIs are becoming a lot more common and with their ability to target specific cells and minimize off-target toxicity, antibody-drug conjugates (ADCs) are being leveraged to treat serious diseases including the cancer treatment area. Pharmaceutical companies are always looking for ways to stay competitive, often by improving upon what is already on the market.
Higher potency drugs have the potential to achieve similar efficacy at a lower dose than other APIs, which is appealing to drug developers because it minimizes patient exposure to medication as a result , most oncological agents are HPAPIs, and we are seeing increasing clients with those types of compounds."

👉 Ongoing research points to new developments in payloads and linkers. How does Angelini expect this to impact the market?

"The impact of novel payloads and improved linker chemistry will be the future. We will start to see more and more of these newer generation products hitting later phases and every new wave should bring differentiating advantages. From a R&D perspective, you need the
technological expertise to support these new developemnts which we have at Angelini."

👉 Where do you see the strengths in Angelini Fine Chemicals (AFC) and HPAPI’s production?

"We operate GMP production suites for gram-scale and multi-kilogram production capacity at our site. We have seen two fronts that have gradually become more and more established over time: Processing protocols: Having quality management and environmental health and safety teams involved in every step of production is critical to maintaining the highest quality standards when using HPAPIs: procedures mandate that safety assessments,
cleaning validation requirements, and handling instructions be in place before any new substance is put on manufacturing or dispensing equipment. Flexible and agile manufacturing: The rapidly changing environment of HPAPI drug development requires flexibility in manufacturing so that production lines can change volumes, processes, and
products to meet changing market demands or clinical trial requirements."

👉 How does AFC offer solutions for HPAPI manufacturing?

"The completed HPAPI capacity expansion covers the addition of two new cGMP kilo-lab suites fully dedicated to the development of small and mid-scale cGMP manufacturing of custom HPAPIs (at high containment levels of OEB5 & OEB6). This new platform offers all scales of HPAPI manufacture across the full OEL / OEB band spectrum to meet a wide range
of pharmaceutical outsourcing services, from route selection/proof of concept runs to scale-up (up to small- and large-volume HPAPI cGMP manufacturing.) At AFC we believe this mirrors the trends in HPAPi drug development including ADCs"

CARLO LUSSO

Sales & Custom Synthesis BD Manager

Angelini Pharma | Fine Chemicals Business Unit