Biopharma firms pressing ahead with serialisation

A US survey has revealed that many US biopharma companies are pressing ahead with plans to adopt serialisation of products in order to boost the integrity of their products, despite the delay to California’s drug pedigree legislation.

Radiofrequency identification (RFID) specialist Blue Vector Systems, with the help of Pharmaceutical Commerce magazine, found that the majority of respondents reported significant planning and investment in capital projects.

Prompted by the US Food and Drug Administration’s Counterfeit Drug Task Force, which called for greater use of technology to tackle drug counterfeiting back in 2004, stakeholders have been investigating and testing a number of approaches aimed at ensuring supply chain security, from manufacturer to patient.

The majority of survey respondents continue to view serialization as a priority in the years ahead.

An encouraging 67 per cent of manufacturer respondents reported that they are already moving forward with their serialisation efforts, with 12 per cent already serialising at least one product in commercial distribution;

Another 12 per cent of respondents said they were conducting a production-scale pilot, with 43 per cent saying they plan to initiate a pilot in the next 12 months.

Just 14 per cent said they had no plans to serialise, with 19 per cent unsure.

81 per cent of those polled said that serialisation technology is either an "important compliance objective" or "an opportunity to derive business value beyond compliance" or both. A minority (10 per cent) dismissed it as a business cost with no additional benefit.

"One of the biggest problems of establishing these security systems is that they require the participation of different industries, which often have different priorities, " commented Nick Basta, editor in chief at Pharmaceutical Commerce.

"This level of engagement is encouraging and is occurring in the face of the State of California's decision to delay their 'e-pedigree' regulations for several years, " he said.