Wednesday, April 3, 2019 Daily Archives

Quality FBS, or just BS? Industry turning to supply chain certification

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Fetal bovine serum (FBS) is the gold standard for growth media but poor quality and counterfeit product pose risks to manufacturing and the patient. Traceability audits and origin determination test can overcome these, says the ISIA. FBS has been used as a culture supplement for the past 65 years and is unlikely to be rivalled in its growth promoting capabilities for some time, Brian Lewis, a representative from the International Serum Industry Association (ISIA) and president of BL Consulting, told…

April 3, 2019

Novo Nordisk making good on CAPEX pledge with $100m Danish spend

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Novo Nordisk’s Kalundborg, Denmark site produces half the world’s insulin, the firm claims, as it looks to upgrade and expand its facilities. In Novo Nordisk’s end of year report, the firm announced its intentions to invest DKK 9 billion ($1.4 billion) in capital expenditure to reinforce its property, plants and equipment in 2019. This week, the Danish drugmaker made good on DKK 650 million worth of its pledge by announcing plans to upgrade and expand its insulin production site in…

April 3, 2019

‘Aging’ biotech AgeX to build Cali cell therapy plant

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AgeX Therapeutics will construct a cGMP laboratory facility in Alameda, California to manufacture cell lines and its biological aging cell-based product candidates. The biotech firm announced in an SEC filing that it has entered into an agreement to lease 23,911 square feet of space in Alameda, California. The space will be used as AgeX’s principal offices and research laboratory, but the firm also intends to construct a cGMP laboratory facility for the manufacture of cell lines and its cell-based product…

April 3, 2019

AZ inks $6.9bn ADC deal with Daiichi Sankyo

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AstraZeneca and Daiichi Sankyo will co-develop cancer antibody-drug conjugate (ADC) DS-8201 in a deal worth up to $6.9 billion. AstraZeneca will pay $1.35 billion (€1.2 billion) upfront for rights to DS-8201 (trastuzumab deruxtecan). The UK firm will pay a further $5.5 billion if the drug achieves regulatory and sales targets. Under the agreement, Daiichi will manufacture DS-8201. AstraZeneca will help develop and sell the drug worldwide, except in Japan where Daiichi has exclusive rights. Spokesman Rob Skelding told us AstraZeneca’s…

April 3, 2019