In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

Learn more about Quality by Design principles and how they can be applied in drug product development to bring better biologics to patients faster. Quality by Design (QbD) has transformed the approach ...

Validating drug production processes need not be a headache, according to AI researchers who say machine learning (ML) could be a single answer to biopharma’s multivariate problem. The FDA defines ...

We used diabetic retinopathy (DR) as a case study to show application of the proposed biomarker development process. Loss or impairment of vision due to DR is one of the most profound complications of ...

ValGenesis Smart GxP™ is the first AI-enabled platform purpose-built to unify validation and process development across the product lifecycle. Featuring five integrated applications—ValGenesis iCMC™, ...

How self-tuning can support an adaptive control strategy. How Model Reference Adaptive Control can improve adaptability. The different types of MRAC. A certain amount of flexibility is always good to ...