Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
News|Articles|November 2, 2015
- Pharmaceutical Technology-11-02-2015
- Volume 39
- Issue 11
Single-Use Shipping Solutions
Sartorius Stedim Biotech’s Flexsafe 3D Pre-designed Solutions meet ASTM D4169 Standard Practice requirements and are designed for storage and shipping of biopharmaceutical fluids.
Single-Use Shipping Solutions
Sartorius Stedim Biotech’s Flexsafe 3D Pre-designed Solutions meet ASTM D4169 Standard Practice requirements and are designed for storage and shipping of biopharmaceutical fluids. Flexsafe features components, functionalities, and quality controls that meet the specific requirements of each step in upstream and downstream processing and in final filling. The three-dimensional single-use bags are available in a range of sizes from 50L to 1000L and are made of a 400-µm thick co-extruded film structure, which reduces the risk of damage to the bag and provides easy installation and self-deployment of bags in containers. The new S80 film features consistent cell growth, robustness, and high quality.
Sartorius Stedim Biotech
Articles in this issue
almost 11 years ago
Using Dynamic Thermal Imaging to Correct Sealing Problemsalmost 11 years ago
CMOs Continue to Improve Overall Biomanufacturing Performancealmost 11 years ago
FDA Overhauls Inspection Operationsalmost 11 years ago
Good Documentation Practice: Saving Data for the Long Termalmost 11 years ago
Identifying Causes Of Delaminationalmost 11 years ago
Piloting Track-and-Trace Implementationalmost 11 years ago
Advances in Heterocyclic Chemistry for API Synthesisalmost 11 years ago
EU’s New Telematics Strategy for the Regulation of Medicinesalmost 11 years ago
Exploring the Potential of Continuous Coatingalmost 11 years ago
Demonstrating Therapeutic Equivalence for Generic Topical ProductsRelated to this article
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.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
Jason Bertola, executive director of Commercial Development for the Advanced Synthesis Platform at Lonza in North America, explains the demand for spray drying and the hurdles involved with scale up, in an interview with PharmTech.
Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.
The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.
Richard Jaenisch explains why NAMs are compressing drug development faster than AI and what FDA's new nonclinical testing rule means for sponsors.