HIGH POTENCY APIS
Case study: The power of an integrated platform
A recurring challenge for biotech firms is the fragmented nature of the HPAPI supply chain. A typical ADC project might involve a mAb from one supplier, a payload from another and a conjugation specialist from a third. Each hand-off introduces regulatory risk and logistical delays. To combat this, Piramal Pharma Solutions developed the ADCelerate * programme.
In one case, a biotech partner required a rapid transition from R & D to Phase I clinical trials for a novel ADC targeting a rare hematologic malignancy. By utilising a coordinated global network, the payload-linker was synthesised at the Riverview, Michigan, site( capable of handling material with OELs as low as 10 ng / m 3), while the mAb was integrated for conjugation at Grangemouth, UK. This integrated approach, which included sterile fill / finish at the site in Lexington, Kentucky allowed for parallel development activities that significantly shortened the traditional development timeline.
Supply chain diversification
Post-COVID supply chain concerns have prompted a strategic shift. Many firms are now diversifying their manufacturing footprint to include at least one location outside China to mitigate geopolitical and logistical risks. This has led to renewed investment in domestic capacities across the US, the EU and India, with governments increasingly viewing API reserves as a matter of national security.
The China Plus One strategy has moved from a defensive riskmitigation tactic to a core strategic imperative for pharmaceutical supply chains. At its heart, this model encourages companies to supplement their Chinese manufacturing footprint with at least one other location— frequently India— to insulate against geopolitical volatility, trade disruptions and regulatory shifts.
For CDMOs like Piramal, the implementation of China Plus One is a sophisticated system redesign rather than a simple vendor swap. The most important pillars include:
• Strategic mapping: Identifying critical materials and key starting materials( KSMs) with a high dependency on a single region
• India as the‘ Plus One’: Leveraging India’ s vast engineering talent and existing manufacturing ecosystem to provide a resilient, high-quality alternative that complements current global operations
• Integrated resilience: Combining backward integration with localised technology transfer capabilities to reduce external exposure without sacrificing costcompetitiveness
• ESG alignment: Embedding environmental and ethical audits into supplier selection, ensuring that supply chain diversification also advances sustainability goals
This approach is recognised as a fundamental competitive advantage and an ethical imperative, protecting patient access to medicine by preventing shortages caused by regional shocks.
Conclusion
The future of HPAPI manufacturing lies in the intersection of ultrahigh containment engineering and digital intelligence. For CDMOs, the goal is no longer just to‘ handle’ potent molecules, but to provide an integrated, technologically advanced ecosystem that can take a drug from discovery to commercialisation with unparalleled speed and safety. As molecular complexity continues to rise, the partnerships forged today through programmes like ADCelerate( see box) will be the foundation of the next generation of cancer therapies. ●
*- ADCelerate is a trademark of Piramal Pharma Solutions
Jean-François Carniaux
VICE PRESIDENT & GLOBAL API TECHNICAL LEAD
PIRAMAL PHARMA SOLUTIONS k + 44 7467 816719 J jean-francois. carniaux @ piramal. com j www. piramal. com
30 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981