Cutting edge process development insights and news from APC.
APC argues that the US Biotechnology and Biomanufacturing Initiative requires deep process understanding, not just new infrastructure, to build genuine supply chain resilience.
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.
On-demand webinar covering CMC digitalization strategies for regulatory submission and tech transfer, including current tools and emerging directions.
Temperature fluctuations in chromatography affect mAb purification yield and consistency. Learn how column jackets and heat exchangers maintain process control.
[Webinar] Explore the benefits of applying CFD to better understand your process.
VLE Therapeutics opens Ireland's first GMP factory-of-the-future for advanced biotherapeutics and vaccines, backed by a €25M investment across APC and VLE.
How APC developed a scalable upstream process for a viral-vectored vaccine, transitioning from roller bottles to suspension bioreactors to meet clinical supply targets.
Optimizing cell culture media directly impacts cell growth, yield, and biotherapeutic quality, enhancing productivity and cost-efficiency.
On-demand webinar on continuous crystallization for API development, covering kinetics modelling, PAT deployment, and additive manufacturing tools for process control.
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