The Process Development Blog

FDA’s 2025 approvals show biologics growing more complex. Learn why next-gen modalities demand stronger analytics, process design, and integrated CMC strategies.

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 case study highlights the significance of particle size analysis via Dynamic Light Scattering (DLS) in the development of vaccines based on the MVA virus.

Automated assembly of hybrid dynamic models for CHO cell culture processes. Doyle, K., Tsopanoglou, A., Fejér, A., Glennon, B., & del Val, I. J. (2023)

APC and VLE founders Mark Barrett and Brian Glennon received the 2022 Pharma Leader award, recognising growth from 2 to 270 staff and development of over 400 medicines.

CFD, discrete element method, and mechanistic modelling enable virtual transfection and transduction optimisation for cell and gene therapy process development.

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

Four essential elements for an ATMP development plan: risk assessment, scaled-up process control, CMC decision records, and early manufacturing integration.