Catalent, Secure Symbology Employ Track and Trace for BI Products

Catalent Pharma Solutions, in partnership with Secure Symbology, Inc. (SSI), entered an agreement to employ Track and Trace serialization technology for the packaging of Biogen Idec products. Successful implementation of the technology will make Biogen Idec fully compliant with California’s ePedigree law.
   
The ePedigree law is aimed at preventing counterfeit drugs from entering the legitimate supply chain. The World Health Organization estimates that one out of every 100 doses of pharma and biopharma products in developed countries is counterfeit. The ePedigree law requires that all medications sold in the state of California as of January 2009 have a unique, serial identifier that can be electronically read for the purposes of authentication. Manufacturers must therefore add Track and Trace technologies such as 2-D barcodes or Radio Frequency Identification (RFID) to their packaging. Track and Trace technologies allow medications to be electronically traced to their point of origin. Packaging for Biogen’s drugs, which treat patients with multiple sclerosis, non-Hodgkin’s lymphoma and rheumatoid arthritis, will use serialized 2-D barcode technology from Catalent’s Philadelphia facility. Small molecule drugs can use either 2-D barcode or RFID technology on their packaging, while biologics-based products predominantly use 2-D barcoding because the effects of RFID technology on biologics have not been evaluated.
   
The partnership allows Catalent to employ SSI’s barcode equipment to serialize the packaging while SSI creates and manages a secure, centralized database of the manufacturer’s critical data at the start of the e-pedigree chain.
   
“Patient safety is of paramount importance to us and this is one more step we can take to help increase the safety of our products,” said Robert A. Hamm, Biogen Idec’s executive vice president, pharmaceutical operations and technology. “In addition to meeting California requirements, 2-D barcode technology will prepare us for other states and countries enacting similar laws.”
   
“Through our partnership with Catalent, SSI developed a patent-pending system that meets Catalent’s rigorous and challenging standards for Track and Trace technologies,” said Graham Sampson, chairman of SSI. “We’re proud to partner with Catalent to help Biogen Idec lead the industry by helping to secure its much-needed therapies and life-saving medications.”
   
“Catalent is the only contract packaging company that has conducted an end-to-end pilot of RFID from the factory floor to the pharmacy, as well as a factory-focused pilot on Serialized Barcodes,” said Renard Jackson, executive vice president and general manager, packaging services, Catalent Pharma Solutions. “Helping biotechnology and pharmaceutical companies incorporate a secure and effective Track and Trace technology within a few short months is critical, since the deadline for compliance is less than a year away.”