Mfg Roundup: News from Lupin, Merck & Co., BioNTech

A roundup of manufacturing news from Merck & Co, Lupin, and BioNTech.

Merck & Co. Issues Recall of One Lot of Antibiotic Cubicin 
Merck & Co. is voluntarily recalling one lot of the antibiotic, (daptomycin for injection) 500 mg, to the user level, including hospital and administering institutions, due to the presence of particulate matter identified as glass particles.

Approximately 22,000 vials are affected by this recall. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of Cubicin after reconstitution.

Cubicin is used to treat complicated skin and skin structure infections.

Source: Merck & Co.

Lupin Issues Recall of Irbesartan Products Due to Impurities
Lupin Pharmaceuticals is voluntarily recalling select batches of irbesartan tablets and irbesartan and hydrochlorothiazide tablets to the consumer level due to potential presence of an impurity, N-nitrosoirbesartan.

As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan. Although Lupin reports it has received no reports of illness that appear to relate to this issue, the company is recalling all batches in the US of irbesartan tablets USP (75 mg, 150 mg, and 300 mg) and irbesartan and hydrochlorothiazide tablets USP (150 mg/12.5 mg and 300 mg/12.5 mg). The drugs are used to treat hypertension and other indications.

The recall follows earlier recalls in the industry for products with nitrosamine impurities, principally for N-nitrosodimethylamine (NDMA), a potential carcinogen. In 2018, the US Food and Drug Administration and the European Medicines Agency initiated investigations of nitrosamine impurities in certain “sartan”-containing active pharmaceutical ingredients, used in anti-hypertensive and cardiovascular drugs, such as valsartan candesartan, irbesartan, losartan, and olmesartan. They later broadened those investigations into 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 later 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 risk assessment.

Lupin discontinued the marketing of irbesartan and irbesartan and hydrochlorothiazide tablets in January 2021.

Source: US Food and Drug Administration

BioNTech Plans Construction of mRNA Vaccine Mfg Facility
BioNTech has announced plans to initiate the construction of its first manufacturing site for mRNA-based vaccines in the African Union in mid-2022.

The decision is the result of a meeting between BioNTech, the Rwandan government, and the Institut Pasteur de Dakar, a non-profit association for public health in West Africa. The meeting resulted in a memorandum of understanding (MoU). This comes after the parties signed a Joint Communiqué at a previous meeting in Berlin, Germany on August 27, 2021. 

The parties agree to jointly establish end-to-end manufacturing capacities for mRNA-based vaccines in Africa starting immediately (as reported on October 26, 2021). BioNTech has finalized the construction plans and ordered the assets, which will be delivered by mid-2022.

BioNTech says it plans to develop and implement a scalable construction network based on the expertise and learnings from the ramp-up of its production facility in Marburg, Germany.

BioNTech will start with the construction and validation of a first production line enabling the manufacturing of drug product for about 50 million of COVID-19 vaccine doses per year, once fully operational. The capacity will be increased sequentially by adding further manufacturing lines and sites to the manufacturing network to support production of several hundreds of millions of mRNA vaccine doses.

Source: BioNTech