Mfg News: Amgen, Pfizer, Novartis, Gilead, UCB, & More
A roundup of manufacturing news from Amgen, Pfizer, Gilead Sciences, UCB, Novartis, Carisma Therapeutics, Fresenius Kabi, and Civica.
Amgen Breaks Ground on New Biomfg Facility
Amgen has broken ground on a new biomanufacturing facility in Holly Springs, North Carolina. The facility, expected to be operational by 2025.
The company has manufacturing facilities in California, Ireland, the Netherlands, Ohio, Puerto Rico, Rhode Island, and Singapore.
Civica To Manufacture, Distribute Biosimilar Insulin Products
Civica, a non-profit pharmaceutical company providing generics and drugs in shortage, has announced plans to manufacture and distribute biosimilar insulins in the US, once approved.
Civica will produce three insulins: (1) glargine, a biosimilar of Sanofi’s Lantus; (2) lispro, a biosimilar of Eli Lilly and Company’s Humalog; and (3) aspart, a biosimilar of Novo Nordisk’s Novolog. Each insulin will be available in both vials and prefilled pens.
Civica says it will co-develop and manufacture the drug product, complete the clinical trials, and file the necessary applications for US Food and Drug Administration (FDA) approval. Civica plans to set a recommended price to the consumer of no more than $30 per vial and no more than $55 for a box of five pen cartridges.
Civica has entered into co-development and commercial agreement with GeneSys Biologics, a Hyderabad, India-based clinical-stage bio/pharmaceutical company, for these three insulin biosimilars. Civica will use drug substance produced in partnership with GeneSys and will have exclusive rights in the US to market and sell these in the US.
The insulins will be manufactured at Civica’s 140,000-square-foot manufacturing plant being built in Petersburg, Virginia. The company says the facility, expected to be operational in early 2024, will have the capacity to produce the amount of insulin needed in the US, with additional space to increase production if necessary. Contingent on FDA approval, Civica anticipates that the first insulin, insulin glargine, will be available for purchase as soon as early 2024.
Civica, along with CivicaScript and The Civica Foundation, is collaborating with 25 partners for this project. A full list of collaborators can be found here.
Pfizer Recalls Blood-Pressure Drug for Nitrosamine Impurity
Pfizer Canada ULC is recalling all lots of a high-blood pressure drug, Inderal-LA (propranolol hydrochloride) extended-release capsules, in 60-mg, 80-mg, 120-mg and 160-mg strengths, due to the presence of a nitrosamine impurity (N-nitroso-propranolol) above the acceptable level.
A long-term exposure to N-nitroso-propranolol at a level above what is considered safe may increase the risk of cancers. As with previous recalls involving nitrosamine impurities, Health Canada, the pharmaceutical regulatory body of Canada, is advising that there is no immediate risk in continuing to take the recalled Inderal-LA medication since the potential risk of cancer is with long-term exposure (every day for 70 years) to the nitrosamine impurity above the acceptable level.
Health Canada says it is monitoring the effectiveness of the recall and the company’s implementation of any necessary corrective and preventative actions.
Source: Canadian government
Gilead Buys Land To Expand Mfg Ops in California
Gilead Sciences has completed the purchase of additional land in Oceanside, California, to expand its manufacturing operations. Under the agreement, Gilead will acquire approximately 27 acres of undeveloped land neighboring its existing facility in Oceanside. The Oceanside location focuses on supporting clinical manufacturing and process development for Gilead and Kite, a Gilead company focused on cell and gene therapies.
Source: Gilead Sciences
Gilead Receives CRL from FDA for HIV Drug on Vial Issues
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) over vial compatibility issues in a new drug application filed by Gilead Sciences for lenacapavir, an HIV drug.
The FDA cited chemistry manufacturing and controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial as the reason for issuing the CRL. The FDA had previously raised questions about vials made of borosilicate glass and their compatibility with lenacapavir solution, which resulted in a clinical hold for injectable lenacapavir.
In June 2021, Gilead submitted the NDA for lenacapavir to the FDA for treating heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The drug was selected for priority review by the FDA.
Source: Gilead Sciences
UCB Investing $218 M for New Gene-Therapy Mfg Facility
UCB is investing EUR 200 million ($218 million) to build a new gene-therapy process development and clinical manufacturing facility at its campus in Braine l’Alleud, Wallonia, Belgium.
The new facility is expected to be operational in 2024. Construction is due to start in the second quarter of 2022.
Once construction is complete the 17,000-square-meter facility will expand UCB’s footprint, which includes sites in Belgium, China, Japan, Switzerland, Germany, the US, and the UK as well create more than 100 new jobs in the gene-therapy area. The company currently has gene-therapy teams in Braine and Leuven, Belgium, and Boston, Massachusetts, and Durham, North Carolina.
Novartis, Carisma Therapeutics in Mfg Pact for Cell Therapy
Novartis and Carisma Therapeutics, a Philadelphia, Pennsylvania-based biopharmaceutical company developing macrophage-based therapeutics, have signed an initial agreement under which Novartis will manufacture Carisma’s HER 2-targeted chimeric antigen receptor macrophage (CAR-M) cell therapy, which is in initial trials for treating solid tumors.
Under the agreement, the Carisma Therapeutics manufacturing process will be transferred to Novartis’ cell-therapy site in Morris Plains, New Jersey, starting in the coming days (as reported on March 10, 2022). Clinical manufacturing is planned to begin in 2023.
Fresenius Kabi Recalls Sodium-Based Injectable
Fresenius Kabi USA, a Lake Zurich, Illinois-based healthcare company, is voluntarily recalling seven lots of sodium acetate injection, USP, 400 mEq/100 mL (4 mEq/mL), 10 mL fill in a 100-mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials.
Sodium acetate injection, USP is indicated as a source of sodium, for addition to large-volume IV fluids to prevent or correct low blood sodium levels in patients with restricted or no oral intake.
The recalled lots were distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between September 2020 and November 2021. To date (as reported on March 9, 2022), the company reports that no adverse event reports have been received for these recalled lots.
Source: US Food and Drug Administration