FDA Approves Temperature-Sensitive Drug for Treatment of Multiple Sclerosis
Multiple sclerosis patients are celebrating with the news that the FDA has approved Ocrevus as the first and only drug for treatment of progressive and relapsing forms of multiple sclerosis. Genentech, a member of the Roche Group, recently made the announcement.
Ocrevus must be transported and stored at 2°C – 8°C. This is vital to the patient. If Ocrevus were to be subjected to temperatures outside that range, its effectiveness would be compromised.
Cold Chain Transportation Risks
During transport is the time when pharmaceuticals are at their most vulnerable. Ensuring that temperature-sensitive pharmaceuticals stay at the required constant temperature throughout the delivery process requires effective packaging solutions. From point of manufacture through delivery to patient, packaging can be subjected to many different risk factors. Handlers with different levels of technical ability, different climate zones, equipment availability, tarmac exposure and ground handling errors are just a few of the many ways the cold chain can be compromised.
Effective Temperature-Sensitive Packaging is Key
CSafe Global offers the only full line of both active and passive temperature-sensitive packaging solutions that provide the required protection for valuable payloads encountering varied conditions during transport.
Passive solutions are designed to meet specific temperature, duration and payload criteria. Solutions include packaging for 2° – 8°C, CRT and frozen, with hold times from 12-240 hours and payload volumes up to 50 liters. Custom solutions are available utilizing CSafe’s ISTA certified testing laboratory.
CSafe’s RKN active pallet shipper allows for uninterrupted routing of shipments and maintains the internal temperature of the payload compartment regardless of transportation risk factors it may face. It is the first of its kind with FAA approval for use on the upper and lower decks of aircrafts.
Genentech Trusts CSafe to Deliver
CSafe Global, a trusted supplier of temperature-sensitive packaging solutions for Genentech, celebrates the FDA’s approval of Ocrevus. With proper handling, the estimated 400,000 M.S. patients in the United States are poised to benefit for the first time from what may well become the leading prescription drug therapy available.