Skip To Content

ACD/Labs Blog

How Chemical Manufacturing and Control (CMC) Software Helped a Major Pharmaceutical Company Improve Process Development and Regulatory Submissions Background: in 2019, a process development team at a top biopharmaceutical company. They felt data management was getting in the way of research and that too much time was spent preparing regulatory submissions. Challenge: the team wanted...

Critically Examining Data Management in ADC Development and Research Antibody Drug Conjugates (ADCs) are a class of therapeutics that utilizes the specificity of monoclonal antibody (mAB) to enable targeted drug delivery. With more than 180 ADCs currently in clinical trials, the ADC market is predicted to grow from $2-3 billion today to over $13 billion...

E&L contains large amount of analytical datasets and chemical information of all impurities associated to each study. Luminata’s ability to be configurable allows it to handle each step within the extractable and leachable process, to store all meta data for each compound found in the study with its corresponding data.

How evolving analytical and automation tools are positively impacting forced degradation studies in pharmaceutical development The goal of stress testing or forced degradation in pharmaceutical development is to comprehensively compile relevant degradation pathways, such that all degradation products are formed at detectable levels. This field has grown significantly in the past 20 years, fueled in...