Serializing Drugs for Pedigrees

Biogen Idec has begun serialization with 2-D bar codes on products such as Avonex, above, with the labeling help of Catalent and Secure Symbology Inc.

Two leading pharmaceutical industry suppliers have joined forces to develop an advanced track-and-trace system that will enable a major drug manufacturer to meet the requirements of California's electronic pedigree law.

Catalent Pharma Solutions (Somerset, NJ) and Secure Symbology Inc. (SSI; Wayne, NJ) announced the exclusive agreement this past January to use their technology for packaging and coding drugs made by Biogen Idec (Cambridge, MA). Catalent specializes in packaging for advanced dosage drugs, and SSI makes anticounterfeiting technology. Biogen, which had revenues of $3.17 billion in 2007, manufactures treatments for multiple sclerosis (MS), non-Hodgkin�s lymphoma, rheumatoid arthritis, and other diseases.

As of press time, California's e-pedigree law was slated to go into effect January 1, 2009. It requires manufacturers of dangerous drugs to create a unique, traceable serial number for each retail box or inner package sold in the state. The electronic pedigree contains information for each transaction along the supply chain until the drug reaches the pharmacy or the dispenser. The size of California's market effectively makes the law a de facto national standard.

Our assumption is that California is simply an early adopter of what will eventually be the standard for distributing biologics throughout the United States, says Robert Hamm, executive vice president of pharmaceutical operations and technology at Biogen Idec.

Hamm points out that Biogen packages two of its drugs Avonex and Tysabri at Catalent's plant in Philadelphia and has enjoyed a successful commercial partnership since the launch of Avonex in May 1996.

Biogen was looking for an experienced partner that could meet the technical requirements as well as the timeline presented by the California State Board of Pharmacy, Hamm notes. The continuing success of its relationship with Catalent, coupled with Catalent's previous experience working with SSI, factored into the decision, Hamm says.

Biogen will use a 2-D bar code technology program developed by Catalent and SSI. Data Matrix will be the 2-D code. The patent-pending solution combines Catalent's packaging expertise and SSI's bar code equipment to serialize individual packages. That information will be tracked through every link in the supply chain and sent to a central database managed by SSI. As others have pointed out, Hamm notes that manufacturers of biologics are reluctant to use radio-frequency identification (RFID) until uncertainty about its potential effects on large-molecule drugs are sorted out.

Sorting out the challenges of creating a bar code technology suitable for Catalent's packaging requirements proved daunting enough in itself, says Kamal Mustafa, SSI's president. SSI presented the 2-D concept to Cardinal Health Group, which created Catalent Pharma Solutions in 2007, approximately four years ago as an alternative to RFID, he says. After signing a development agreement with SSI, Catalent told us it would take us six months to do this, and the funny part is, it took us two-and-a-half years, Mustafa says.

The challenges presented for the packaging line are equivalent to making a three-cushion billiards shot. The design criteria for integrating SSI's technology on the production line of the world's largest packager involved footprint, speed, stability, accuracy, and the ability to print on a variety of substrates and containers, Mustafa notes.

Their first criterion was the size of the footprint, which had to measure between 30 and 36 in., he says. In that 36 in., it was supposed to grab the carton at speeds in excess of 200 packets a minute, stabilize it, print on the carton, dry the bar code, scan the bar code, and grade it from A to C, where C is acceptable.

The system is designed to reject bar codes that don't receive A or B grades. All these capabilities must operate without affecting the speed of the packaging line in the slightest, Mustafa says. Even if you could print at a high enough clarity to have the traditional bar code at A-grade level, if you try to print a 2-D bar code using the same quality, it would fail the grading.

SSI also had to develop a secure system that could handle the flood of scanned data. Drug manufacturers' internal computer systems were not designed to accommodate the ever-filling reservoir of accumulated digital information that must be kept  for a long time, says Mustafa.

Because manufacturers traditional software couldn't handle the task, SSI turned to a centralized data vault structure of the type used by government. The serialization vault can accommodate the global hodgepodge of e-pedigree regulations because it's totally agnostic to the requirements and the lack of standards, Mustafa asserts.

A typical line such as Biogen's will feature three units, with one for track-and-trace and two for aggregation, Mustafa says. The cost ranges from $300,000 to $500,000 and decreases greatly for simpler labeling lines, he adds.

Akan Oton, Catalent's global marketing director for packaging services and clinical supply, says Catalent will use the new system at the company's plant in Philadelphia. Oton says the technology offers three specific benefits. The first is that it helps manufacturers avoid the chaos of managing this large-scale data. The second is that the central repository can authenticate product with a broken pedigree. The third is that it gives small drug makers without the necessary internal resources a cost-effective outsourcing alternative.