The business case for regulated AI turns on the cost of producing an outcome that the quality system can accept.
|Articles|November 8, 2022
Enhance Quality and Productivity in Your mAb Manufacturing
Author(s)Thermo Fisher
When looking to scale-up monoclonal antibody (mAb) manufacturing, a crucial challenge can be delivering sustained or improved product quality with productivity enhancements. Having consistent product quality is essential to ensure patient safety and product efficacy. Manufacturers are therefore placing greater emphasis on optimizing upstream processes. Developed using an advanced multi-omics and bioinformatics modelling approach, the Gibco™ Efficient-Pro™ Medium and Feed System has been specifically formulated to help address productivity and quality challenges. This complete solution brings together two high-performance products, working in total harmony, to accelerate your workflow into a new era. Read the app note and discover the future of mAb manufacturing.
Related to this article
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
Structural modifications can improve peptide stability, solubility, and absorption to enable effective oral delivery.
The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Trending on Pharmaceutical Technology
1
FDA’s New Inspection Playbook Counts Remote Assessments and MRA Reports Toward Facility Evaluations
2
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
3
RRP Accelerated Approval: What VOCERYQ Means for Manufacturing Teams
4
Who Answers for Your Data? Building a Life Sciences Data Mesh
5