The Process Development Blog

This on-demand webinar from The Medicine Accelerator examines how ATMP developers can move from lab-scale development toward GMP manufacturing with stronger process understanding, quality control, and technology transfer planning. The session focuses on an oncolytic virus case study that achieved a 400% increase in viral yield and a 90% reduction in cost per dose. Topics include ATMP process development, upstream and downstream optimization, impurity profile improvement, manufacturability, GMP readiness, regulatory considerations, tech transfer, clinical manufacturing capacity, and faster time to patient.

In this presentation, Alexandra Bogdanovic, from APC’s bioprocess development team, delves into some of the key challenges and strategies associated with AAV production optimization.

This on-demand webinar from APC explores how Crystallization-Induced Diastereomeric Transformation, or CIDT, can improve diastereomeric salt crystallization for chiral resolution. The session covers solubility behavior, phase relationships, counterion selection, solvent choice, solid-state control, and analytical strategies for improving enantiomer separation. It is relevant for pharmaceutical development teams working on chiral molecules, double salts, crystallization process design, yield improvement, purity optimization, scale-up, and enantiopure compound production.

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.