The Process Development Blog

Data generated throughout a medicine’s CMC development journey is often fragmented, siloed and lacks context - causing regulatory bottlenecks, manufacturing delays, and ongoing quality issues. During this discussion, panelists explore the criticality of data visibility in the CMC journey and learn practical strategies to improve data management, contextualization, and integrity.

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.

Doyle, K., Tsopanoglou, A., Fejér, A., Glennon, B., & del Val, I. J. (2023). Automated assembly of hybrid dynamic models for CHO cell culture processes. Biochemical Engineering Journal, 191, 108763. https://doi.org/10.1016/j.bej.2022.108763

APC and VLE are set to give key technical talks at the 2022 AICHE Annual Meeting, Nov 13-18 during the 'Particle Agglomeration and Granulation Processes' and the 'Particle Technology in Product Design and Manufacturing' session.

Do you wish you could improve the efficiency of delivering genes to cells? Learn how employing mechanistic modelling + CFD to understand and optimize transfection and transduction efficiency can increase yield and lower costs.

In the development of Biologics, a lack of proper process understanding and control often leads to an inability to adequately scale a process, product quality drift and costly delays arising from batch failures and concerns of the regulatory authorities which need to be addressed. APC has developed a unique approach designed to mitigate these issues.

In this webinar, we share methods to screen and optimize reactions under extreme time constraints using flow chemistry setups integrated with PAT.

Predicting or measuring the percolation threshold, using statistical models or experimentation, is an evidence-based approach that can help get solid dosage forms designed faster.

Computational methods play an increasingly important role in all stages of drug development and when used judiciously can help accelerate the timelines required to get over various process and manufacturing hurdles.