US contract manufacturer Catalent Pharma Solutions has leveraged its partnership with Secure Symbology (SSI) for track and trace barcode technology to help biopharmaceutical company Biogen Idec comply with California's pending ePedigree law.
Following their link-up last August, Catalent and SSI have signed an agreement under which packaging for Biogen's drugs will use serialised 2-D barcode technology from Catalent's Philadelphia facility.
Catalent has exclusive rights to employ SSI's anti-counterfeiting technology in its contract manufacturing operations. Under the partnership, Catalent uses SSI's barcode equipment to serialise its clients' packaging, while SSI creates and manages a secure, centralised database of the manufacturer's critical data at the start of the e-pedigree chain.
The anti-counterfeiting specialist says it has developed a patent-pending system that "meets Catalent's rigorous and challenging standards for track and trace technologies".
The e-pedigree mandate provides a means of authentication to guard against the growing threat of counterfeit drugs entering the system. On 1 January 2009, California will implement new legislation requiring all prescription drugs sold in the state to have a unique, serial identifier that can be read electronically and is fully interoperable with the whole of the supply chain.
Traceability must extend from a drug's origin at the manufacturer all the way down to the pharmacy, with updating of the record or pedigree whenever there is a change of ownership.
As Catalent points out, pharmaceutical manufacturers can meet these requirements by adding track and trace technologies such as 2-D barcodes or radio frequency identification (RFID) to their packaging. In the case of biologics-based companies such as Biogen Idec, the solution is expected to be predominantly 2-D barcoding, as the effects of RFID technology on these products have not been evaluated.
Track and trace technologies also improve the bottom line by enabling pharmaceutical and biotechnology companies for the first time to track effectively inventory and returns throughout the supply chain, Catelent adds. It claims to be the only contract packaging company to have conducted an end-to-end pilot of RFID "from the factory floor to the pharmacy", as well as a plant-focused pilot of serialised barcodes.
With the deadline for compliance with the ePedigree law now less than a year away, helping companies "incorporate a secure and effective track and trace technology within a few short months is critical", commented Renard Jackson, Catalent's executive vice-president and general manager, packaging services.
A number of companies, including IBM (partnered with Tagsys), Nosco, Systech and SupplyScape, are offering RFID-based systems that adhere to California's ePedigree legislation.