Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.
|Podcasts|June 29, 2022
The Right Partner to Advance Your Molecule From Gene to Commercialization – The Right Step to Advance Your Molecule
Author(s)Samsung Biologics
Samsung Biologics is responding to industry challenges with various development projects and services that improve overall timelines and efficiencies when manufacturing new medicines.
- Advantages of outsourcing development projects to CDMOs,
- Preventing challenges and starting the development process quickly, and
- Choosing a CMO partner with a highly optimized cell line platform.
Related to this article
Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.
PharmTech AI Pulse Check panelists explain why attribution, audit trails, and sign-off matter more than AI watermark detection for GxP quality teams.
Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Trending on Pharmaceutical Technology
1
What the Olanzapine Depot Approval Means for CMC Teams
2
Pritelivir Shifts Resistant Herpes Care from Intravenous to Oral
3
Q&A: Patient-Centric Drug Development Should Start at Product Definition
4
PharmTech AI Pulse Check: AI Watermark Vulnerability
5