Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
|Podcasts|October 29, 2021
Accelerate your Drug to the Marketplace through the Right Partnership
Author(s)Samsung Biologics
All drugs approved in the US marketplace went through an extensive, multi- million dollars, multi-year journey before being available to patients. In order to bring a new drug to the market place requires extensive resources, technical acumen, and an unbendable commitment to the goal. CDMOs are alongside pharma companies helping them navigate the process and mitigate risk. By choosing the right partnerships, you can give your drug production the competitive advantage it brings to the marketplace. Listen to Soojin Han, Director of the CLD group at Samsung Biologics, as she talks about what is the CDMO partnership and how Samsung Biologics can help many scientists for drug development to speed up the drug product to the marketplace and support many people's health life.
Related to this article
The business case for regulated AI turns on the cost of producing an outcome that the quality system can accept.
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.
Trending on Pharmaceutical Technology
1
FDA’s New Inspection Playbook Counts Remote Assessments and MRA Reports Toward Facility Evaluations
2
Improving Oral Peptide Delivery Through Structural Modifications
3
Who Answers for Your Data? Building a Life Sciences Data Mesh
4
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
5