Mfg News: FDA, Sanofi, J&J, Hetero, Grifols & More
A roundup of manufacturing news from the US Food and Drug Administration, Sanofi, Hetero, Grifols Bavarian Nordic, and the California Biomanufacturing Center. Highlights below.
* FDA Reports Shortages of Adderall
* Sanofi To Sell Japan Mfg Facility to Adragos Pharm
* Hetero Buys Former J&J Mfg Plant
* Bavarian Nordic, Switzerland in Supply Pact for Monkeypox Vaccine
* Grifols Opens Albumin Purification and Filling Plant
* California Biomanufacturing Center Launches BioProcessing Network With Support from former Google Chairman/CEO
FDA Reports Shortages of Adderall
The US Food and Drug Administration (FDA) reports a shortage of the immediate-release formulation of amphetamine mixed salts, commonly referred to as Adderall or Adderall IR.
The FDA says it is in frequent communication with all manufacturers of amphetamine mixed salts, and one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays. The FDA says that other manufacturers continue to produce the drug, but there is not sufficient supply to continue to meet US market demand through those producers.
The FDA has posted information on the shortage, including a list of current manufacturers and product strengths that are still available, and says it will continue to monitor supply and assist manufacturers to resolve the shortage and will update its Drug Shortages webpage with new supply information as it becomes available.
Source: The US Food and Drug Administration
Sanofi To Sell Japan Mfg Facility to Adragos Pharm
Sanofi has agreed to transfer the ownership of its manufacturing site in Kawagoe, Japan, to Adragos Pharma, a Munich, Germany-based CDMO of drug products. The site manufactures oral solids and sterile liquids and conducts packing, visual inspection, and retesting services for the Japanese and Asian markets.
Adragos Pharma will continue to manufacture for Sanofi under a long-term supply agreement and become its strategic partner for the Japanese market. Workers at the Kawagoe remain at the site. Adragos Pharma says it intends to further expand the site’s services and capabilities.
The transaction is subject to customary closing conditions.
Source: Adragos Pharma
Hetero Buys Former J&J Mfg Plant
Hetero, a Hyderabad, India-headquartered pharmaceutical company, has acquired a former Johnson & Johnson (J&J) manufacturing plant in Penjerla, Telangana, India. The facility is spread across 55.27 acres, and will become Hetero’s flagship sterile pharmaceutical and biologics manufacturing unit. The company says it is committed to investing upwards of $75 million to upgrade and enhance existing facilities at the site and expand manufacturing of its global biologics and sterile pharmaceutical products.
With the facility, Hetero aims to add 2,000 new jobs in biochemistry, pharmaceutical sciences, molecular biosciences, engineering, and ancillary services.
Hetero acquired the Penjerla manufacturing facility together with the land, plant, and machinery in a slump sale, which refers to a sale for a lump sum consideration without values being assigned to individual assets, from J&J.
Source: Hetero
Bavarian Nordic, Switzerland in Supply Pact for Monkeypox Vaccine
Bavarian Nordic, a Hellerup (near Copenhagen), Denmark-based vaccine company, has announced that the Swiss Federal Office of Public Health and the Swiss Armed Forces have jointly ordered 100,000 doses of the company’s smallpox and monkeypox vaccine. First deliveries will start imminently (as reported on October 14, 2022), and final deliveries will occur in early 2023.
As part of the agreement, Bavarian Nordic will submit an application to Swissmedic, the Swiss national regulatory agency, within three months (as reported on October 14, 2022) to support a potential marketing authorization of the vaccine against smallpox and monkeypox in 2023.
Bavarian Nordic has ongoing supply contracts with the US and Canada and has delivered the vaccine to a number of undisclosed countries globally as part of their national biological preparedness. In addition to smallpox, the US Food and Drug Administration, Health Canada, and the European Commission have approved the vaccine for use against monkeypox. The company says it is working to expand its manufacturing capacity to fulfil global demand in the medium- to long term.
Source: Bavarian Nordic
Grifols Opens Albumin Purification and Filling Plant
Grifols, a Barcelona, Spain-based provider of plasma-derived medicines and a CDMO, has inaugurated a new albumin purification and filling plant at its global manufacturing and supply hub in Dublin, Ireland.
The newly built plant adds more than 17,000 square meters to Grifols’ Grange Castle facilities, located just outside Dublin, and triples the annual filling production capacity of Grifols’ flexible container, Albutein FlexBag, which is used for storing, transporting, and administering albumin.
Dublin is one of five manufacturing sites for plasma-derived medicines for the company, which also includes sites in the following: Barcelona, Spain; Clayton, North Carolina; Los Angeles, California; and Dreieich, Germany. Additional Grifols manufacturing sites under construction will become operational in Montreal, Canada, in 2024, and in El Cairo, Egypt, in 2025.
Source: Grifols
California Biomanufacturing Center Launches BioProcessing Network With Support from former Google Chairman/CEO
The California Biomanufacturing Center (CBC), a public–private partnership to advance biomanufacturing in the US, has launched the BioProcess to Product (BioP2P) Network, a program to accelerate the transformation of manufacturing in the US for the growing bioeconomy.
Schmidt Futures, a philanthropic fund established by Eric Schmidt, former CEO and Chairman of Google/Alphabet to use science to tackle pressing world problems, is supporting the BioP2P Network. In April (April 2022), Schmidt Futures issued a report to identify a strategy for what it would take for the US and the world to maximize the benefits of the bioeconomy. In October 2021, it mobilized the Task Force on Synthetic Biology and the Bioeconomy to provide recommendations and solutions to lay the groundwork for a strong and efficient bioeconomy and also identified funding opportunities.
CBC is using the Schmidt Futures grant to bring together stakeholders across the US to foster scale-up for non-biomedical technology developers across the country to move from pilot to commercial production.
An initial priority for the BioP2P Network will be to create a national inventory of validated, scale-up facilities. This open-access inventory of facilities will allow developers to readily partner.
The BioP2P Network will begin meeting this month (October 2022) to help companies identify scale-up processing capacity in that country that is available to them.
