The Process Development Blog

Decentralized manufacturing in pharma, driven by ATMPs, is now extending to traditional large & small molecule medicines, transforming development & production.

Process portability is a concept pioneered by APC which encompasses the capability to seamlessly transfer robust manufacturing processes across different facilities or locations without compromising product quality or efficiency

The recent wave of CDMO acquisitions, COVID-19, and global geopolitical uncertainty has underscored the need for pharmaceutical companies to future-proof their manufacturing operations against potential disruptions. In such a climate, Process Portability emerges as a strategic imperative, offering pharmaceutical companies a proactive approach to safeguarding their operations.

In this webinar, we will explore the development of a 2nd generation downstream process for a complex biotherapeutic and discuss strategies to significantly reduce the number of unit operations, increase yields, reduce costs, and accelerate time-to-market while meeting CQA specifications.

[PANEL DISCUSSION] CMC data is often fragmented, siloed and lacks context - causing regulatory bottlenecks, manufacturing delays & quality issues.

[WEBINAR] Experts review challenges, proven strategies for tech transfer, & an unique approach using digitalization, process optimization, & risk management.

A lack of process understanding & control leads to: inability to scale, product quality drift, & costly delays from batch failures & regulatory concerns