Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
|Articles|November 1, 2017
- Pharmaceutical Technology-11-02-2017
- Volume 41
- Issue 11
Temperature-Controlled Shipping Solution
The Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is compliant with good distribution practices and comes in three models.
Almac Group has expanded availability of the Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, to the United States as part of the company’s end-to-end, global supply chain management solution. Originally released in Europe, the service is compliant with good distribution practices and comes in three models: protected, optimized, and dynamic.
The protected model is qualified for up to 96 hours against thermal challenges by the International Safe Transit Association and is available in -15 °C to -25 °C, +2 °C to +8 °C, and +15 °C to +25 °C temperature ranges. The optimized model is also qualified for up to 96 hours of protection, eliminates temperature excursions, is suited for reuse with no shippers left at the clinical site, and requires no disposal. The dynamic model features upgraded operational processing capacity and flexibility, and uses a phase-change material to offer increased thermal protection. It can be immediately placed into appropriate storage at each point of packing and in-transit. For this model, Almac has the ability to perform a year-round pack out of clinical shipments.
Articles in this issue
almost 9 years ago
Establishing an Effective Data Governance Systemalmost 9 years ago
ODTs Dissolve Drug Administration Challengesalmost 9 years ago
Reducing Medication Errorsalmost 9 years ago
Patient Centricity Takes Center Stagealmost 9 years ago
Europe Leads the Way in Continuous Manufacturingalmost 9 years ago
Change Control for Standard Operating Proceduresalmost 9 years ago
CDMO Acquisitions Build Strategic Supplier Basealmost 9 years ago
A Revised Aseptic Risk Assessment and Mitigation Methodologyalmost 9 years ago
FDA Overhauls Inspection Process and Field Operationsalmost 9 years ago
Awards Recognize Industry ContributionsRelated 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.
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