Friday, January 22, 2021 Daily Archives

Rooster Bio and Sartorius team to streamline hMSC production

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Cell bank firm Rooster Bio has teamed with Sartorius to find ways of scaling-up production of stem cell-based regenerative therapies. The collaboration will combine Rooster’s human mesenchymal stem/stromal cell (hMSC) working cell banks and media systems with Sartorius’ single-use manufacturing tech, process control software and analysis tools. The aim is to provide “robust, streamlined, end-to-end platform technologies and protocols that can be implemented for rapid scale up of manufacturing processes, allowing product developers to significantly speed up their development timelines, 

January 22, 2021

FAQs: Challenging host cell protein assays for improved risk mitigation

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Host cell proteins (HCP) are critical to quality control in biologics development. If left unremoved, they can cause immunogenic responses and reduce drug efficacy. In our last webinar we shared Cytiva’s strategy for designing a comprehensive HCP risk mitigation strategy. We discussed how to challenge your assays early to ensure accurate measurements, build confidence, and reduce the risk of unexpected HCP levels. Our HCP experts highlighted and responded to the most common questions raised around host cell protein assays. Want…

January 22, 2021

MA center aims to speed up manufacturing for researchers, says Cytiva

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A $76 million innovation and manufacturing center will alleviate production backlogs of up to 18 months, says founding member Cytiva. The Massachusetts Center for Advanced Biological Innovation and Manufacturing (CABIM) will partner with industry and academia to reduce backlogs which impact critical research and development. The $76 million in financing was led by Harvard University and supported by other founding members: Massachusetts Institute of Technology (MIT), Fujifilm Diosynth Biotechnologies, Alexandria Real Estate Equities and Cytiva (formerly known as GE Healthcare…

January 22, 2021

Biocon: COVID dampens $1bn biosimilar sales target

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COVID-19 has caused regulatory inspection delays, operational slowdowns and lower consumption, diminishing Biocon’s aspiration of reaching $1 billion in annual biosimilar revenues. On paper, Biocon’s third quarter FY21 was positive. Sales grew 7% year-on-year to INR 1,879 crore ($258 million), with an 11% growth in biosimilars contributing INR 769 crore to the total. Quarter-over-quarter, biosimilar sales grew 14%, and Biocon’s presence in marketed biosimilars further grew with a number of approvals across various jurisdictions, including EMA recommendation for its insulin…

January 22, 2021

Podcast: Systemic racism in the biomanufacturing space

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Black and minority workers are consistently overlooked in the biomanufacturing industry due to unconscious – or perhaps conscious – racism, LucasPye Bio CEO Tia Lyles-Williams explains in The BioProcess Insider Expression System podcast. In the first episode of this new podcast series, Tia-Lyles Williams, CEO of LucasPye Bio, talks about diversity in the biopharma workplace and the hurdles that continue to hold back black and minority workers. Tia now leads a Philadelphia-based CDMO that recently raised $50 million in funding…

January 22, 2021