Thursday, September 16, 2021 Daily Archives

Simplify Analytical Development for Measuring Residual Plasmid DNA in mRNA, Gene Therapy, and Other Biologics Manufacturing

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This webcast features: Tania Chakrabarty, PhD, Senior Manager, Innovation Leader, Research and Development, Pharma Analytics, Thermo Fisher Scientific Plasmids are common raw materials in the manufacturing of various biotherapeutics, from use as template for mRNA vaccines to gene introduction via transfection of mammalian cells for viral vector production. Worldwide regulatory agencies (WHO, EMA, US FDA, etc.) require that clearance of residual plasmid process-related impurities via downstream purification be demonstrated to below the accepted limit in the final drug substance. Previous…

September 16, 2021

Pfizer: Trial management and manufacturing key to DMD gene therapy success

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Pfizer has stressed the importance of having the right manufacturing capabilities as it looks to be first to market with its gene therapy for Duchenne muscular dystrophy (DMD). Orphan disease DMD is an X-linked disorder caused by mutations in the gene encoding dystrophin, which is needed for muscle membrane stability. The disease affects around 140,000 boys worldwide, 30,000 of which are in the US and Europe. Most of the current treatments do not address the underlying cause, but gene therapies…

September 16, 2021

Thermo Fisher invests $154m to expand NC plant

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Thermo Fisher will increase manufacturing capacity for fill-finish services at its Greenville, US facility with an $154 million investment.  Bioprocess vendor Thermo Fisher Scientific has unveiled plans to bolster its manufacturing capacity for sterile liquid and lyophilized filling, pre-filled syringes, and solid dose continuous manufacturing at its Greenville, North Carolina facility. The $154 million investment is not part of the firm’s recent $600 million CAPEX plan, which had the trade press salivating in March.  “Our continued growth in capabilities and capacity at our Greenville site has enabled us to support our clients’ needs and…

September 16, 2021

Cytiva makes good on China single-use expansion

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Plans to triple single-use component production in China through a longstanding partnership with Wego Pharmaceutical are well underway, says Cytiva. Wego Pharmaceutical Co.’s Weihai, China facility makes single-use bioprocessing consumables on behalf of Cytiva after the two firms forged a partnership in November 2018. The site will expand its capacity through plans envisaged last September but announced last week. “Three new manufacturing lines were launched in under ten months with an additional eight new lines planned to launch in Q3…

September 16, 2021

AGC Bio bolsters pDNA and mRNA capacity with German plant expansion

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CDMO AGC Bio will expand its Heidelberg, Germany facility to increase its manufacturing capacities for customer pDNA and mRNA projects. The expansion, of which financial details have not been disclosed, sees contract development manufacturing organization (CDMO) AGC Biologics boost its current production capacity for plasmid-DNA (pDNA) and messenger RNA (mRNA) by adding an additional manufacturing line. The Heidelberg expansion will also include additional warehouse capacity, a cleanroom for mRNA development and production, and a process development lab for microbial protein…

September 16, 2021