The Process Development Blog

Looking forward to seeing you November 14-16, 2023 in San Diego, CA USA at Booth 13!

We will be at booth 77 Oct 16-19, 2023 in Barcelona to discuss your vaccine development and manufacturing challenges. Don't miss the presentation and technical poster from our technical experts.

Visit our unique “Medicine Accelerator” facility in Dublin where we’re redefining the future of pharmaceutical manufacturing through our unwavering commitment to a groundbreaking concept – "Process Advancing Medicine."

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.

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.

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.