Catalent, SSI are Biogen's ePedigree chums

By Pete Mansell

- Last updated on GMT

Related tags Pharmacology Biogen

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.

Related news

Show more

Related products

show more

Ultra Low Temperature Packaging solutions

Ultra Low Temperature Packaging solutions

Content provided by Almac Group | 12-Feb-2024 | Case Study

Advanced Therapy Medicinal Products (ATMPs) offer ground-breaking opportunities for treating injuries and disease, in particular for cases of severe, untreatable...

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Unlock potential in buffer preparation

Unlock potential in buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 18-Sep-2023 | Infographic

Consider how the right partner can help you scale faster, mitigate risks, and optimize resources.

Follow us