Monday, October 4, 2021 Daily Archives

Standardized AAV manufacturing: Why are AAV reference materials needed?

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The field of gene therapy is in great need for well characterized AAV reference materials, according to viral vector delivery services firm Vigene Biosciences. Recombinant adeno-associated virus (rAAV) is a widely used gene delivery tool for research and clinical applications in the gene therapy field. To compare the pharmacokinetics and efficacy of rAAV, well characterized AAV reference materials are needed for assays and in-house reference materials calibration. AAV reference materials are also essential for AAV in process development and AAV…

October 4, 2021

In brief: Moderna to invest in R&D headquarters

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Moderna will build a science center in Cambridge, Massachusetts to support and advance its pipeline of mRNA vaccines and therapeutics.  Messenger RNA (mRNA) firm Moderna will construct a purpose-built space to support the company’s research and development efforts. The site will be known as the Moderna Science Center, located at 325 Binney Street in Cambridge. “We have been located in Massachusetts since our founding more than 10 years ago and are proud to be based here. As we advance our mRNA platform…

October 4, 2021

Thermo Fisher opens Swiss biologics plant

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Thermo Fisher will assume operational responsibility for a biologics manufacturing facility in Lengnau, Switzerland as part of its collaboration with CSL Limited. The 1.5 million square-foot plant will become part of Thermo Fisher Scientific’s global biologics manufacturing network. The facility will house flexible bioproduction technologies, such as single-use and stainless steel with up to 12,500 L bioreactor capacity. Thermo Fisher took over operations at Lengnau in June 2020 after it entered a strategic partnership with CSL. “Through our partnership with…

October 4, 2021

FDA authorizes 9th batch of J&J COVID vax from troubled Emergent plant

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The US FDA has authorized an emergency use authorization (EUA) for one additional batch of the Janssen COVID-19 vaccine manufactured at Emergent’ Bayview facility. Contamination issues stemming from Emergent BioSolutions marred rollout of J&J’s ‘Janssen’ single dose COVID-19 vaccine earlier this year. The contract development and manufacturing organization’s (CDMO) Bayview, Maryland facility had been contracted by both J&J and AstraZeneca, but an ingredient mix up rendered 15 million doses unusable and landed the plant with an FDA Form 483 and a…

October 4, 2021