Production and supply of kit for the preparation of ^99mTc-HYNIC-TOC injection for the diagnosis of neuroendocrine tumors: Our experience over a decade at Board of Radiation and Isotope Technology

Tyrocine-3-Octreotide (TOC), a tailor made octapeptide is specific for somatostatin receptors.^99mTc-HYNIC-TOCimaging is used for diagnosis and follow-up of neuroendocrine tumors (NETs). ^99mTc- HYNIC-TOC injection is being routinely produced and supplied by BRIT since 2013 under product code TCK-54. HYNIC-TOC was procured from overseas suppliers and SnCl₂.2H₂O was from Sigma-Aldrich. Since 2013, 35 batches of HYNIC-TOCkits were prepared, batch size ranging from 30 – 60 kit vials and this involved handling of 1 – 2 mg of HYNIC-TOC per batch. Radiolabelling of kit vial involves the addition of maximum 2220MBq/60mCi of ^99mTc in the form of NaTcO₄ followed by heating in boiling water bath for 20 min. So far, 35 batches corresponding to 1800 vials were formulated. Since, HYNIC-TOC is susceptible to ambient temperature, transport of raw material and the finished products are carried out in dry ice packaging. These kits were found to be stable up to nine months when stored at 20℃, however, considering logistics and other factors, expiry date of the kit is 6 months from the date of production. Over the years, around 1450 kit vials (maximum 4350 diagnosis) were supplied to Nuclear Medicine Centers throughout India with utmost customer satisfaction. Production of kit formulations at cGMP, ISO 9001:2015 & ISO 13485:2016 certified facility at BRIT, Navi Mumbai by well-trained scientists, strict adherence to SOPs resulted in zero batch failure till date