The Process Development Blog

Decoupling process development from manufacturing enhances control, flexibility and innovation - accelerating time to market and reducing risks in pharmaceutical development.

Michael Jordan is widely regarded as the greatest basketball player of all time. But beyond his athletic prowess, his philosophy offers invaluable lessons for CMC professionals. Discover how the principles that guided MJ’s legendary career can be applied in pharmaceutical manufacturing.

In this webinar, Guangyang Hou, a Senior Process Development Engineer at APC, explores how model-supported approaches in conjunction with the implementation of Process Analytical Technologies (PAT) and continuous processing, can minimize human intervention whilst drastically reducing development times.

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.

Using data-rich experimentation and mixing models, which leverage CFD, a right-first scale up of the new process was achieved within the yield improvements translating directly back to the plant.

A Chinese Hamster Ovary (CHO) mammalian cell process moved to a PAT-enabled continuous feed strategy to prevent nutrient loss & stabilize the macroenvironment.

For the synthesis & crystallization of APIs, Mixed Suspension Mixed Product Removal Crystallizers (MSMPRCs) can help address common issues in batch production.

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

[Webinar] Dr Brendan Roche reviews engineering strategies for unit ops (crystallization, isolation, etc.) when manufacturing molecules w/ complex stereochemistry.