In this week’s news, US CDMO sector is set for growth, Avantor and Cytovance team on plasmid production, and more.
Avantor and Cytovance Biologics have teamed up to make manufacture research and GMP grade plasmids for biopharma customers.
The partnership, details of which were announced this week – is designed to cater for growing demand from gene therapy developers according to Ger Brophy, Executive Vice President, Biopharma Production for Avantor.
“Demand for therapeutic biologics in the gene therapy space is increasing rapidly and will require increased manufacturing capacity and expertise.”
This was echoed by Naomi Seresinhe, Senior Vice President of Business Operations for Cytovance Biologics, who said, “Production of plasmid DNA extends our microbial capabilities.”
Demand for locally made APIs and injectable drugs is likely to drive the expansion of the contracting sector in the US according to a new report.
The report – available here predicts that the US pharmaceutical contract manufacturing organization (CMO) market is expected to reach a CAGR of 5% during the forecast period of 2022 to 2027.
The authors cited the growing appetite for active pharmaceutical ingredients made in the US as one major driver, explaining “The demand for API manufacturing witnessed a sustained rise in the past few years, and it is expected to continue growing steadily.“
They also forecast that higher demand for non-branded products will also help US CDMOs, explaining that “generics will continue to dominate prescription drug usage.”
Contractors with cytotoxics capacity will be in demand the authors said, writing that “Owing to the robust demand for oncology and other high-potency drugs, cytotoxic drugs are expected to be the key growth driver for the injectable dose formulation segment.”
RAPS looked at US FDA draft guidance outlining how the agency assess product benefit-risk profiles during quality assessments for new drug applications (NDA), biologics license applications (BLAs), and supplements.
Fierce Pharma analysed Hovione’s drug delivery technology focused accord with Ji Xing Pharmaceuticals.
Contract Pharma covered Ardena’s plans to upgrade its development and manufacturing facilities in Pamplona, Spain with investments in dry granulation technology and upgrades to its spray drying capabilities.
Neuvivo announced that Patheon has started making NP001, a candidate ALS treatment at its facility in Florence, South Carolina.
Lexology reported that Ukraine may cancel marketing authorizations for pharmaceuticals held by companies with ties to drug manufacturing in Russia or Belarus.
KATC news reported that the US Department of Commerce’s has awarded the Acadiana Planning Commission a grant to develop local biopharmaceutical manufacturing under the “American Rescue Plan.”
Some developments of note in the contracting sector:
eureKARE has announced plans to merge multiple EU firms to establish a gene therapy, protein drug and microbiome therapeutics CDMO. Read Reuters’ coverage here and Endpoints take here.
InfectoPharm has hired Societal CDMO to make Ritalin LA capsules (methylphenidate hydrochloride extended-release capsules) for the European market.
Taiwan-based CDMO Bora Pharmaceuticals has establishment a new biologics contracting wing called Bora Biologics Co.
Health Canada has issued Eurofins CDMO Alphora with a processing license for its Oakville, Ontario Operations under the Cannabis Act and Cannabis Regulations.
PCI Pharma Services plans to expand capabilities and capacity in aseptic liquid fill-finish and sterile lyophilization technology at its Bedford, New Hampshire campus.
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