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Enzyvant to build regenerative med plant in NC to support Rethymic

Enzyvant says the construction of a regenerative medicine facility in Morrisville, North Carolina will bolster its size, flexibility, and capability to support its commercial needs. Financial details of the expansion remain under wraps, but regenerative medicine focused firm Enzyvant says the development of a 25,972 square-foot facility will begin this summer and take around two and a half years to complete. The plant is located within the Research Triangle Park area and is being co-developed by and operated with Sumitomo…

Shingrix sales bounce back post-pandemic for GSK

GSK says its vaccine turnover for this quarter benefited from Shingrix’s post-pandemic recovery in the US and Europe. For the first quarter 2022, GlaxoSmithKline (GSK) reported its vaccine business made a total of ÂŁ1.7 billion ($2.1 billion) in sales. ÂŁ698 million ($866 million) of this was made up of Shingrix sales, the firm’s non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). According to GSK, its vaccine business benefited from Shingrix’s “strong demand recovery.” The firm claims it…

The Impact of Protein Stability on Virus Filtration

Filtration of protein-based biologics is essential for minimizing viral contamination and ensuring product safety and high quality. The tendency of therapeutic monoclonal antibodies (MAbs) and recombinant proteins to aggregate under a number of conditions can complicate selection of a virus filter. An increasing demand for high concentration formulations creates additional challenges. When performing filterability studies and to ensure meaningful virus filter evaluations, downstream process scientists must address factors that can lead to aggregation. This special report on virus filtration by…

eBook: Intensifying Processes for Monoclonal Antibodies

The commercial manufacturing success of monoclonal antibodies (MAbs) has become a touchstone of the biopharmaceutical industry. MAbs are so well established that they often are referred to as “traditional” biologics, and well-known MAb processing methods have become a model for processing of other “advanced” or “emerging” therapies. But MAb processing continues to advance as biomanufacturers seek ways to improve efficiencies, lower costs, and (most recently) increase sustainability of facilities. Drug makers are particularly interested in strategies for MAb process intensification.…

Genezen fast tracks second phase expansion in US

Genezen’s aggressive approach has not been aggressive enough says firm as a second phase expansion begins earlier than expected at its lentiviral vector plant.   Gene therapy contract development manufacturing organization (CDMO) Genezen Laboratories has completed construction of a 75,000+ square-foot lentiviral vector production facility in Indianapolis, US and says the next phase of the expansion is underway. The firm said it had allocated space for future expansions but did not expect to be initiating the next phase of the…

Novartis CGTs first quarter 2022: Zolgensma up, Kymriah down

Novartis reports increased sales for gene therapy Zolgensma due to expanded global access, but the failure in the second-line DLBCL setting will affect Kymriah sales. For Swiss Pharma giant Novartis’ cell and gene therapy (CGT) division, first quarter 2022 results were mixed. On the positive side, Zolgensma (onasemnogene abeparvovec) pulled in $363 million during the quarter, up 18% year-on-year due to increased access outside of the US. Sales of the one-time spinal muscular atrophy (SMA) gene therapy — approved in the…

Formulation lap: Sanofi turns to McLaren for manufacturing efficiency

Sanofi has teamed with Formula 1 racing team McLaren to optimise manufacturing efficiencies within its network. The multiyear deal will see Sanofi’s Industrial Affairs team benefit from McLaren Racing team’s digital and analytical expertise tto achieve excellence in manufacturing operations. “Analysis of losses, modelling and simulation of production line scheduling, and specifically product change-overs, will be key areas to maximise performance in Sanofi manufacturing sites,” McLaren said in a press release. Both Sanofi and McLaren Racing “operate in a truly…

NorthX Biologics inks vaccine partnership with Abera

NorthX has signed a partnership agreement to upscale and manufacture Abera Biosciences’ vaccine candidate against pneumococcus, Ab-01.12.   Abera is a vaccine and platform development company, which was founded in 2012 as a spinout from Swedish production firm Xbrane Bioscience. Its lead vaccine candidate Ab-01.12 is administered as a nasal spray and aims to treat pneumococcus using technology designed to protect against all variants of the bacterium. Abera is preparing the vaccine candidate for clinical trials in humans and has…

Host cell protein impurities in viral vector manufacturing: a critical quality attribute for product efficacy and safety

Viral vector manufacturing processes require rigorous analytics, including testing for process-related impurities such as host cell proteins (HCP), host cell DNA, growth media additives and enzymes used in viral vector purification processes [Cellular and Gene Therapy Guidances]. Even after multiple purification steps, significant levels of HCP impurities can be present. While low levels of most impurities can be inconsequential, patient safety demands that HCPs be eliminated or reduced to the lowest levels practical to prevent problems such as adverse immune…

China’s I-Mab allegedly seeking asset or company sale

Shanghai-based I-Mab is in talks with global drugmakers about a potential sale of the whole company or its oncological assets, according to a Bloomberg article. The Bloomberg article claims US and EU pharmas were interested in I-Mab, given its portfolio of 10 clinical stage oncology antibodies plus access to the world’s second largest pharmaceutical market. Bloomberg noted that I-Mab has lost three-fourths of its market value since the prices for pharmaceutical companies peaked in June 2021. When it announced its…