HPAPI

High-Potency APIs

In the realm of high potency active pharmaceutical ingredients (HPAPIs), precision and safety are paramount. At APC we specialize in HPAPI process development, offering a comprehensive suite of services (including, modeling, advanced analytics and continuous processing amongst others) tailored to meet the unique challenges of this specialized domain.

Cutting-Edge Containment Facilities

We have developed a unique digitally driven work-flow for HPAPI’s which typically results in a 20-30% reduction in development timelines compared to traditional approaches for these modalities. This workflow is underpinned by an array of in silico process modeling capabilities which enable hundreds of virtual experiments to be conducted in a very short space of time – meaning that the “wet lab” development is given a head-start towards right first time experiments.

On transferring the experiments from the digital to the “wet lab” environment, all the work is performed in our state-of-the-art dedicated containment facility. This is fully equipped with all the necessary infrastructure including:

• Isolators, gloveboxes, Hepa-filtration, air handling, etc.

• Walk-in fume hoods offering flexible spaces for running complex operations under high containment (e.g., end-to-end continuous processes)

• Full complement of PAT (FBRM, ATR-FTIR, Raman, EasyViewer) for data-rich experimentation

• In-lab analytical equipment for rapid analysis (HPLC, DSC, Malvern, XRPD, Microscopy)

This has enabled us to work across a range of modalities and formulations including small molecules, Antibody Drug Conjugates, LNP formulations and other materials requiring containment. Routinely our capabilities enable us to handle compounds in the range of OEL 0.1-1 µg/m3. We have also supported development of medicines down to the ng/m3 level.

By prioritizing engineering-first principles, we delve deep into accessing the intricacies of your manufacturing process to understand how to best operate in either batch or continuous mode. This ensures that even with HPAPI’s, we maintain the capability to develop well understood manufacturing processes without compromising on scalability or robustness.

In addition, we couple unique combination of modeling and wet lab capabilities with a first-in-class CMC digitalization ecosystem, iAchieve, which tracks and curates data in real-time and provides visibility to every CMC decision made on your molecule’s journey, and more importantly, which experiment, data point or insight informed that decision. This takes away the headaches associated with tech transfer and also enables you to easily answer CMC related questions from the regulators.