The Process Development Blog

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.

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.

Tech transfer is fraught with challenges, and it's crucial to have a solid understanding of the process, as well as, modern strategies for success. Our experts review challenges, discuss proven strategies for successful tech transfer, and highlight how VLE Therapeutics takes a unique approach to tech transfer through a focus on digitalization, process optimization, and risk management.

Faster development despite rising stereochemical complexity! In this webinar, Brendan Roche, PhD reviews engineering strategies which can be applied to key unit operations (e.g. crystallization, isolation etc.) of enantiomers and diastereomers of varying stereochemical complexity.

Speed development without comprising on quality! In this webinar, Hasbullah Daud, PhD discusses PAT, modelling, and cutting-edge analytical techniques to accelerate the development of this pioneering therapeutic modality.

We’re delighted to announce that our founders Mark Barrett and Brian Glennon received the “Pharma Leader” award at the 2022 Pharma Industry Awards during a gala in Dublin this evening. APC also recieved the prostigous "Pharma Company of the Year" award.

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.

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.