Mfg News: FDA, Merck & Co., Assure Infusions & More

A roundup of manufacturing news from FDA, Merck & Co., Assure Infusions, and SmartLabs.  Highlights below.

* FDA Reports Nitrosamine Impurity in Diabetes Drug Sitagliptin
* Assure Infusions Building IV Fluids Mfg Facility
Lab-as-a-Service Company SmartLabs Expanding Lab, Mfg Space

FDA Reports Nitrosamine Impurity in Diabetes Drug Sitagliptin
The US Food and Drug Administration reports that it recently became aware of a nitrosamine impurity, nitroso-STG-19 (known as NTTP), in certain samples of sitagliptin, the active ingredient in Merck & Co.’s Januvia, a drug to treat Type II diabetes. To avoid a shortage and help ensure patients access to an adequate supply of the drug, the FDA says it will not object to the temporary distribution of sitagliptin containing NTTP above the acceptable intake limit of 37 ng per day, and up to 246.7 ng per day.

NTTP belongs to the nitrosamine class of compounds, some of which are classified as probable or possible human carcinogens based on laboratory tests, according to information from the FDA. Although there are no data available to directly evaluate the carcinogenic potential of NTTP, FDA said it used information available on closely related nitrosamine compounds to calculate lifetime exposure limits for NTTP.

Agency scientists evaluated the risk of exposure to NTTP at interim acceptable intake levels up to 246.7 ng per day and determined that it presents minimal additional cancer risk when compared to a lifetime of exposure to NTTP at the 37 ng per day level.

NTTP represents another nitrosamine impurity being evaluated by the industry. The issue of nitrosamine impurities first surfaced in 2018 when the FDA and the European Medicines Agency initiated investigations of nitrosamine impurities in certain “sartan”-containing APIs, used in anti-hypertensive and cardiovascular drugs such as valsartan candesartan, irbesartan, losartan, and olmesartan. They later broadened those investigations to include prescription and over-the-counter forms of ranitidine, a H2 (histamine-2) blocker used to decrease the amount of acid created by the stomach, and metformin extended-release products, used to treat Type II diabetes. As part of their investigations, the regulatory agencies issued guidelines for testing of products to detect nitrosamine impurities, acceptable daily intake levels, and risk evaluation and assessment. Companies also issued voluntary recalls of products found or potentially having levels of these impurities above acceptable intake levels.

Source: US Food and Drug Administration

Assure Infusions Building IV Fluids Mfg Facility
Assure Infusions, a Winter Haven, Florida-based company that launched earlier this year (2022) to produce IV fluid products, is building a 60,000-square-foot manufacturing facility in Bartow, Florida. The facility is scheduled to open in 2023.

Source: Assure Infusions

Lab-as-a-Service Company SmartLabs Expanding Lab, Mfg Space
SmartLabs, a Boston-based Laboratory-as-a-Service company, plans to open life-sciences research and production space in Philadelphia.

SmartLabs designs, builds, and operates research environments, including multifunctional research and development labs, vivaria, process development, pilot-scale manufacturing, and cGMP suites for companies. It is targeting Philadelphia as a location to support companies involved in cell- and gene-therapy development and manufacturing.

The 508,000-square-foot facility, developed by Gattuso Development Partners in partnership with New York-based Vigilant Holdings, will be based on Drexel University’s campus, and offer R&D, vivarium, and manufacturing suites. SmartLabs will occupy two floors in the building, which is expected to be completed in 2025.

SmartLabs currently operates four locations in Massachusetts—Kendall Square, East Cambridge, Boston Landing, and the Seaport District, as well as one location in California – South San Francisco.

Source: SmartLabs