Mfg News: EU, Novartis, AstraZeneca, & More

A roundup of manufacturing news from AstraZeneca, Novartis, Viatris, Bavarian Nordic, and the European Commission. Highlights below.

AstraZeneca Investing $68 M in Irish Mfg Facilities
* Novartis Resumes Radioligand Drug Mfg in Italy & NJ
* Viatris Recalls One Batch of Insulin Glargine Injection Pen
* Bavarian Nordic To Supply US Gov’t 2.5 M More Doses of Monkeypox Vaccine
* EU, Latin America & Caribbean Form Vaccine, Drug Mfg Partnership

AstraZeneca Investing $68 M in Irish Mfg Facilities
Alexion, AstraZeneca’s Rare Disease group, has announced a EUR 65 million ($68 million) investment in new and enhanced capabilities across three sites in Ireland: College Park, Blanchardstown, and Monksland Industrial Park, Athlone.

The investment covers the installation of new drug-substance production equipment and warehousing facilities to support ambient and cold storage at its sites in College Park and Athlone and the construction of a Manufacturing Sciences & Technology Lab at College Park to facilitate biologics drug-substance manufacturing.

The investment follows the company’s announcement last year (2021) to build an active pharmaceutical ingredient facility at its College Park campus.

Source: IDA Ireland

Novartis Resumes Radioligand Drug Mfg in Italy & NJ
Novartis has restarted radioligand therapy (RLT) production at its sites in Ivrea, Italy, and Millburn, New Jersey, and resumed delivery of doses in a phased approach. The company restarted production in early June (June 2022) after remediating issues that led to the temporary, voluntary suspension of production at the sites in May (May 2022).

In addition, Novartis is investing in the expansion of RLT production capabilities at its sites in both Millburn and Ivrea and is building a new radioligand manufacturing facility in Indianapolis, Indiana, which will be operational in 2023.

Source: Novartis

Viatris Recalls One Batch of Insulin Glargine Injection Pen
Viatris is recalling in the US one batch of insulin glargine (100 units/mL), 3-mL prefilled pens packaged in cartons of five pens to the consumer level. This batch is being recalled due to the potential for the label to be missing on some pens.

The recall pertains only to the unbranded interchangeable biosimilar insulin glargine-yfgn pens and does not impact the branded interchangeable biosimilar Semglee (insulin glargine-yfgn) injection pens.

The batch was manufactured by Biocon and was distributed by Mylan Specialty L.P. in the US between April 4, 2022 and May 5, 2022. 

Source: Viatris

Bavarian Nordic To Supply US Gov’t 2.5 M More Doses of Monkeypox Vaccine
Bavarian Nordic, a Copenhagen, Denmark-based vaccine company, has entered into an agreement with the US government to supply an additional 2.5 million doses of its monkeypox vaccine, Jynneo. The vaccine, which is a non-replicating smallpox vaccine, is also approved by the US Food and Drug Administration (FDA) for monkeypox. Deliveries will start in the fourth quarter of 2022 and continue through early 2023.

This additional order follows a previous order signed last month (June 2022) with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, for the delivery of 500,000 doses of the vaccine in 2022. With a previous order from BARDA for 1.4 million doses awarded in 2020, the company is providing 4.4 million doses to the US in 2022 and 2023. Since 2003, Bavarian Nordic has worked with the US government on the development, manufacturing, and supply of a non-replicating smallpox vaccine.

The doses will be manufactured from bulk vaccine already manufactured and invoiced under previous contracts with BARDA and currently stored at Bavarian Nordic. This inventory of bulk product will also be used for manufacturing a freeze-dried version of the vaccine, which is scheduled for delivery from 2023 and onwards, pending approval by the FDA of the freeze-drying manufacturing process.

Source: Bavarian Nordic

EU, Latin America & Caribbean Form Vaccine, Drug Mfg Partnership
Ursula von der Leyen, President of the European Commission, and Pedro Sánchez, Prime Minister of Spain, announced late last month (June 2022) the launch of a new European Union–Latin America and Caribbean partnership on local manufacturing of vaccines, medicines and other health technologies to further enhance social, economic, and scientific ties between the regions.

The initiative, which is being developed and will be implemented with Latin American–Caribbean partners, will support ongoing regional efforts, including the Plan for Self-Sufficiency in Health Matters, which was endorsed by the Community of Latin American and Caribbean States (CELAC) in September 2021, and which sets out lines of action to strengthen capacities to produce and distribute vaccines and medicines in the region. The partnership will follow an approach similar to the Team Europe initiative on manufacturing and access to vaccines, medicines, and health technologies in Africa, which covers supply, demand and an enabling environment for sustainability. Team Europe initiatives are joint efforts facilitated by the European Union at both a country and EU level. The new EU–Latin American–Caribbean partnership will cover supply, demand, and an enabled environment for sustainability and focus on continent-wide actions with potential to underpin systems and drive change on: 

  • Private-sector engagement, supply chains, and finance for manufacturing capacity;
  • Technology transfer, research, and innovation; and
  • Regulatory frameworks and the enabling environment.

Source: European Commission