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.

CSafe Cold Chain Lane Mapping

Just like any other risk-based assessment activity, the process of assessing your partners starts with a clear and detailed step-by-step analysis of how your product gets to the wholesaler/buyer/finishing plant etc. Depending upon the complexity of the route and nature of the product, using a cross-departmental internal workshop to physically map the variety of hand-over points is always a useful starting position and often uncovers previously unknown gaps.

Using GDP guidance documents such as those from the EU, WHO, or PDA, it is possible to compile a ‘checklist’ of compliance requirements for each respective outsourced supply chain partner against which an audit schedule may be assembled.

To learn more about the reliance on manufacturer-shipper collaboration for maintaining supply chain integrity, view the white paper here.


Brian Kohr, President and CEO CSafe Global

It might sound laborious or difficult to add the ‘return cycle’—but this is not true.  CSafe can reduce delays and costs with fast turnarounds and the packaging is returned ready and qualified for reuse.  With no need to track the packaging and guarantee of supply, REPAQ is the simple program.  The key to success when introducing a reusable packaging service is the education of the end users because, once they understand it, they get behind it.  We work with our customers to educate their clients about the benefits reuse procedures.  This communication prior to the launch of REPAQ ® enables the customer and their client to be involved and committed to the success of the program.


Everyone knows the mantra – reduce, reuse, recycle – but reusing temperature-sensitive packaging has not been the normal practice in the pharmaceutical/life science sectors. However, changes are afoot.

Nadine Siqueland, VP Global Sales for CSafe Global, explains, “Reducing the amount of packaging going to landfill is a priority for corporations and governments and one of the best ways of achieving this is to reuse as much as possible, as often as possible.”

The global market for sustainable packaging is forecast to reach $244 billion by 2018, according to a report by Smithers Pira(1). The same report also found that of 141 top companies that are part of the World Business Council for Sustainable Development, those that used sustainable strategies performed better in almost every market segment than their respective counterparts. On average, the sustainable companies returned about 4% higher margins.

However, in the pharmaceutical supply chain, reusing packaging has not been normal practice as packaging degrades with time and transportation conditions and the extent of the degradation (and thus performance) cannot be gauged by eye. This is one of the reasons why CSafe introduced REPAQ®, the first reuse packaging program that thermally re-qualifies packaging prior to reuse. In 2014, customer participation in CSafe’s REPAQ program grew by 47% and the customers are averaging return levels of between 55 and 81% (averaging 74%) with significant savings in both landfill and program costs.

Nadine added “ULDs and expensive thermal cool boxes are widely reused, but many in the cold chain have been wary of reusing other insulated packaging because they could not guarantee its performance more than once. However, based on REPAQ’s historical performance, when packaging is professionally re-qualified to ensure its viability, then it is safe to reuse again and again. Customers in our REPAQ program return the packaging to us, we clean it, inspect it, re-qualify it via thermal testing and return it to the customer ‘as good as new’. The regulators are much more supportive of this model.”

(1) The Future of Sustainable Packaging to 2018


2014 HPCLC Fall Conference

By Brian Kohr, CSafe Global President and CEO

It was another opportunity for great discussions and learnings at the October Health and Personal Care Logistics Conference in Florida.  As in previous post-conference blogs, I recommend that those involved in healthcare company supply chain management should attend.  The conference topics continue to be relevant and the discussions engaging.  The fall conference is moving to Chicago next year and hopefully the new venue will allow for even more registrants to obtain the evermore difficult approval to attend.

The biggest revelation for me at this conference was around the ‘storm’ that is brewing in the supply chain sector.  With the lack of truck drivers and pending legislation affecting their hours; the consolidation and super slow steaming on the ocean; ocean carriers that cater to high-volume shippers instead of providing the special services demanded by the healthcare industry; the full bellies of aircraft; the changes in the dimensional weight calculations; and the overloaded rail system, supply chain costs are going to increase and so are the inventories on company balance sheets.  Some queries emphasizing this were:

  • Who knows someone under 30 who wants to be a truck driver?
  • Who has seen their ocean transit times increase due to super slow steaming as the ocean carriers look to lower their costs to get back to profitability?
  • Who has been on a plane recently that has had plenty of open seats?  Is it the same down in the cargo hold?

As a result of these shifting dynamics, how supply chain professionals must prepare for so many challenges and constant change, especially in the biopharma industry where sometimes lives hang in the balance based upon successful delivery of drugs, I have a better appreciation for cold chain logistics than ever before.

My nephew recently graduated with a degree in supply chain and now works for a manufacturer in Ohio.  I have always been of the opinion that the best way to learn business was to go into public accounting (yes I am biased).  I now believe that supply chain, when it comes to manufacturing specifically, allows for people to obtain a strong understanding of the drivers within a given business be they from the demand side engagement with sales and marketing, the supply side with plant operations, or the transportation and procurement side of the business to understand the external challenges.

CSafe Global is but a small part of the biopharma supply chain, albeit we believe a very important one.  Know that our goal will continue to be to provide products and services that deliver value within your supply chain whether through cost savings, performance improvements or sustainability initiatives.  We will strive to make temperature-controlled shipments the least of your worries so that you can focus on the big picture and that ‘storm’ that was a HPCLC presentation and discussion topic.