Last week, Ampio Biopharmaceuticals was forced to delay the release of Phase III trial data after temperature fluctuations during shipment damaged its osteoarthritis study drug Ampion. Similarly, 850,000 tubes of an eye-care ointment were recalled by Valeant subsidiary Bausch + Lomb in July, after crystal particles formed when the products were subjected to freezing conditions in the shipping process.
Both examples will be costly for the firms involved, therefore demonstrating the importance of safe distribution and storage of drugs and trial material. However, differences in specifications and needs for pharmaceuticals means there is no ‘one size fits all’ solution, according to ex-GSK Quality Director Peter Murray.
For drug products, “the story of the three bears and their porridge comes to mind – some don’t like it too hot, some don’t like it too cold and for the very picky ones, it has to be just right within narrow limits,” he told Outsourcing-Pharma.com. He added: "temperature is the main thing which is controlled but humidity is also a potential issue for some products."
The ‘Big Switch’
The advent of biopharmaceutical ‘living’ products has been the “big switch” in the storage and distribution industry, according to supply chain solutions firm Marken.
“With biologics the full distribution chain including the storage at depots is critical,” Ariette van Strien, SVP of Commercial Operations, told us. “Hence the importance to work with purpose built GMP depots, chose the right packaging (the most secure but also the most cost efficient one) and provide a full lane mapping before you ship your drugs.”
Marken was not the company involved in the shipping of Ampion, but van Strien told us such an example shows the importance of including supply chain planning into the general feasibility phase of a clinical programme.
“Before we ship a product, we invest a lot of time to set up the appropriate lanes and work closely with our clients,” she continued. This includes a Quality or Technical Agreement mapping out all routes with a clear contingency plan in place for each of the lanes provided, as well as consultation with a client as to the best packaging to be used
“The key to success is really to plan upfront and include your supply chain partner as early as possible into the planning phases.”
Van Strien’s comments were mirrored by fellow distribution company World Courier. Spokesperson Sue Lee told us the problem of temperature damage “happens far too frequently,” and World Courier helps avoid this through the planning of routes, checking of documents, and the understanding of local needs to speed up the clearance process.
She added the company - which was also not the logistics firm contracted by Ampio - uses “prequalified packaging tested to a range of external temperatures, with phase change material temperature controlled media which give much better temperature control.”