Mfg News: Chiesi, GSK, Sanofi & More
A roundup of manufacturing news from Lilly, Chiesi, CSL, GSK, Sanofi, Ferring Pharmaceuticals, and Zealand Pharma. Highlights below.
* Chiesi Launches New $434-M Biotech Center of Excellence
* US Gov’t Awards $72-M to CSL, GSK, Sanofi for Bird Flu Vaccines
* Ferring Opens New Gene-Therapy Mfg Facility
* Zealand Pharma Receives Complete Response Letter from FDA for Contract Mfg Issues
Chiesi Launches New $434-M Biotech Center of Excellence
Chiesi Group, a bio/pharmaceutical and healthcare group, has announced the operational launch of its new EUR 400 million ($434 million) Biotech Center of Excellence in Parma, Italy, dedicated for developing and producing monoclonal antibodies, enzymes, and other proteins.
This center will provide production for biologic drug substances from mammalian cells, drug products, and final packaging. Of the approximately EUR 400 million that Chiesi will invest in the site, EUR 120 million ($130 million) is allocated to infrastructure, and EUR 260 million ($282 million) will be spent over the long term (2024–2030) on materials, technologies, skills development, and training.
The Center of Excellence will employ up to 200 specialists, with current technical activities involving 60 people, expected to grow to over 80 by the end of 2025.
Source: Chiesi Group
US Gov’t Awards $72-M to CSL, GSK, Sanofi for Bird Flu Vaccines
The US government has awarded approximately $72 million to fund additional doses of influenza A(H5) (i.e., bird flu) vaccines from CSL Seqirus, Sanofi, and GSK as part of the US government’s national preparedness program.
The award is from the Biomedical Advanced Research and Development Authority (BARDA) under the Administration for Strategic Preparedness and Response (ASPR) Center, which is part of the US Department of Health and Human Services.
Under existing agreements, CSL Seqirus, Sanofi, and GSK will fill–finish additional doses of their influenza A(H5) vaccines from bulk storage into ready-to-use vials or prefilled syringes so that vaccine will be ready to distribute if needed. The companies also will manufacture additional bulk influenza antigen, which is the component of vaccines that stimulates an immune response, from seed stocks that are well matched to circulating strains.
In addition, Sanofi will preserve a continuous domestic egg supply so that the company is ready to manufacture egg-based influenza vaccines, such as the H5 influenza vaccine, at any time of the year. BARDA has worked with Sanofi since 2006 to ensure the ongoing capability to produce egg-based pandemic influenza vaccines year-round.
Separately, BARDA is providing $121.4 million to CSL Seqirus for general pandemic influenza preparedness and vendor managed inventory of additional adjuvant of the company’s H5 influenza vaccine.
Source: The US Department of Health and Human Services
Ferring Opens New Gene-Therapy Mfg Facility
Ferring Pharmaceuticals, a Saint-Prex, Switzerland-based bio/pharmaceutical company, has opened a global manufacturing hub in Kuopio, Finland, for producing Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy for treating certain forms of bladder cancer.
The 25,000-square-meter facility provides adenovirus vector-based gene therapy manufacturing in large quantities. In addition, Ferring is nearing completion of a new manufacturing facility for the drug product of the gene therapy at its US campus in Parsippany, New Jersey.
Source: Ferring Pharmaceuticals
Zealand Pharma Receives Complete Response Letter from FDA for Contract Manufacturer
Zealand Pharma, a Copenhagen, Denmark-based bio/pharmaceutical company, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application (NDA) for dasiglucagon, a drug for treating certain forms of hypoglycemia, due to manufacturing issues at a contract manufacturer.
Dasiglucagon is indicated for the prevention and treatment of hypoglycemia in pediatric patients seven days of age and older with congenital hyperinsulinism (CHI) for up to three weeks of dosing.
The CRL is related to the timing of a reinspection at a third-party contract manufacturing facility that was completed in August/September 2024. The third-party manufacturer has not yet received its inspection classification following the reinspection. A prior inspection of the facility had identified deficiencies that did not involve dasiglucagon. The CRL did not state any concerns about the clinical data package or safety of dasiglucagon, according to the company.
The regulatory review of dasiglucagon is being conducted in two parts under the same NDA. Part 1 relates to dosing of up to three weeks (for which the CRL was issued) and Part 2 relates to the use beyond three weeks. Supporting the use of dasiglucagon in CHI beyond three weeks, the FDA requested additional analyses from existing continuous glucose monitoring datasets from the Phase III clinical program. Zealand expects to submit these data by the end of 2024.
Source: Zealand Pharma
