Growing Number of Biologics Expand and Challenge Transportation Services

Pharma IQ

The market for biologics is expected to see significant growth in the foreseeable future. This follows a strong two years which saw the category contribute 17 percent of global pharmaceutical sales in the 12 months leading to March 2009, according to IMS Health.

Figures released from EvaluatePharma in the same year predicted by 2014 seven of the top ten drugs will be biologics. "Anti-cancer antibodies appear set to easily become the most valuable therapeutic class of drug," the report forecast, based on the moves being made by big pharma at the time.

However, the possibilities presented by biologics are also accompanied by their own challenges, with one notable example being transporting them to the customers who need them in an increasingly global market place.

Growth of biologics leads to expanison of transportation services

Many biologics require both time and temperature controlled distribution, a sector in which regulation is expected to grow in the years ahead.

Realising the need for timely distribution of such products, a number of major names within the pharmaceutical supply chain have expanded their services in this area.

"Plasma and recombinant derivatives, coagulation biotherapies and biologics are life-saving therapies that present customers with unique challenges," Ted Boyle, from McKesson said as the company announced the opening of a new plasma and biologics unit in 2009, which it claims will "multiply supply chain benefits" by allowing customers to receive pharmaceutical products and biologics through the same distribution channel.

UPS announced in January 2011 that it is planning a significant expansion of its services for the pharmaceutical industry, including a new regional distribution facility in Singapore to deal with the rapid expansion of markets in Asia, which will include cold chain facilities for temperature controlled products, such as biologics.

In North America the company is opening new facilities in Louisville and Burlington, both located near airports – which play an increasingly important role in distribution as manufacturing crosses more international boundaries.

Bill Hook, vice president of global strategy at UPS Healthcare Logistics, said: "We are seeing increased demand from healthcare manufacturers wanting more agile supply chains. This clear industry trend is driving companies to look for more global solutions and deeper supply chain partnerships."

Regulations and harmonisation for biologic transfer

The Perishable Cargo Regulations (PCR), as implemented by the IATA, are some of the key regulations in force to ensure temperature controlled biologics are not compromised during transit.

Many of the regulations were enforced in 2009, but July 2010 saw the latest changes, made to chapter 17 of the regulations and designed to improve temperature and time controlled distribution channels, introduced.

The idea is simple, adding a specially approved label to all products requiring such transportation; however it only came about as a result of collaboration between many of those in the pharmaceutical supply chain.

Handling at the airport is one of the most likely places where a cold chain breach can occur. "As much as 54 percent of temerature excurisons happen at the airport," said Kevin O’Donnell Director & Chief Technical Officer, Tegrant Corp, ThermoSafe Brands & Chair IATA, at Pharma IQ's 10th Annual Cool Chain Europe 2011. The new label hopes to reduce by providing a standardised system for all those not just involved in the pharmaceutical industry, but also in food and beverage sectors.

Sentry Biopharma, a United States based company which specialises in supply and cold chain management, explained while in the past five years significant advancements have been made within the ground transport of temperature controlled products, air cargo systems still have some way to go.