According to the memorandum of understanding (MoU), the tablet and capsule manufacturer will use Applied DNA Sciences’ SigNature technology to develop molecularly tagged empty hard-shell capsules.
Under the agreement, a molecular tag embedded in ACG’s gelatine and hydroxypropylmethyl cellulose (HPMC) capsules will allow for authentication across the pharma supply chain.
“The ability to forensically test a capsule in the field and quickly prove its provenance is a powerful tool for all nodes of the pharmaceutical supply chain and will ensure a more secure and traceable global pharmaceutical supply chain,” said Applied DNA Sciences’ president James Hayward.
ACG CEO Selwyn Noronha explained that testing and authentication will be undertaken by pharmaceutical manufacturer, using either one of two options: “One is using a field device/kit in a warehouse. The second is by availing services of a third-party testing hub run by Advance DNA Sciences.”
“The end consumer will not be able to do the testing,” he added.
Track & trace
Although serialization is specific to pharmaceutical packaging, Noronha told us adding an authentication feature to a hard capsule shell conforms to track and trace efforts globally.
“With the introduction of stricter regulatory norms and measures across the globe, the pressure lies increasingly in improving existing supply chain safeguards,” said Noronha.
“This association will equip pharmaceutical companies with greater capabilities to thwart the threat of counterfeits by providing an amplified traceability solution across the supply chain,” he added.
Noronha told us its drugmaker clients will benefit from the MoU, as it will help improve patients’ trust.
“ACG’s capsules with this solution will thus benefit manufacturers to enhance the patient’s trust and confidence in their products,” he said.
Last year, Applied DNA Sciences announced a MoU with Colorcon Inc., under which the excipient and coating firm applied the “molecular taggant” technology to its film coating, ink and colour dispersion systems.