Friday, May 13, 2022 Daily Archives

Application Note: Early-Stage Process Optimization for Seamless Scaling of MSC Therapies

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A single dose of MSC therapy could consist of billions of cells per patient. To sustainably meet this clinical demand, cell expansion processes must be transformed from static cultures to suspension-based systems. This application note describes an efficient approach to process optimization in a scale-down model for suspension-based cell expansion. Read more to learn how to: • Comprehensively screen media and components for optimal cell growth • Rapidly characterize phenotypic and functional CQAs of MSCs • Develop process knowledge early…

May 13, 2022

CAR-T approvals marred by autologous manufacturing limitations, says Allogene

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Autologous therapies have not kept up with demand says Allogene Therapeutics, which claims only off-the-shelf cell therapies can serve larger patient populations. While the approval of Novartis’ Kymriah (tisagenlecleucel) in 2017 marked a breakthrough for chimeric antigen receptor (CAR) T-cell therapies, the sector has been slow to blossom. However, the past year or so has seen some breakthroughs in the space: Approvals for Bristol-Myers Squibb’s Breyanzi (liso-cel) and Abecma (ide-cel), and J&J’s Carvykti (ciltacel). Meanwhile, last month Gilead’s Yescarta (axicabtagene…

May 13, 2022

Analytical Tools to Improve Production of Full Capsids in Initial Stages of AAV Process Development

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This webcast features: Ivana Petrović Koshmak, PhD, Head of Upstream Process Development, BIA Separations, now a Sartorius company. Empty AAV capsids are known contributors of immunogenicity in gene therapy products. Reducing them below 10% during downstream process is difficult if they constitute the vast majority of total AAV produced in harvest – the solution is a further optimization of harvest. Determining the factors that improve production of full AAVs is possible at the initial stages of upstream process development, with…

May 13, 2022

ALSA latest VC firm to contract Lonza to service its portfolio

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Lonza says small to mid-sized companies represent the bulk of its customers as it adds ALSA Ventures’ biopharma portfolio to its client list. European biotech investment firm ALSA has contracted Lonza to help develop and manufacture molecules within its biologics and small molecule company portfolio. The deal, financials of which have not been divulged, will see ALSA’s portfolio companies – which include Promatix, Montis Biosciences, Epsilogen, and Oxford BioTherapeutics – leverage Lonza’s development and manufacturing services and network, along with…

May 13, 2022

Bora Pharmaceuticals bolsters CDMO biz with Eden buy

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As part of its five-year plan, Bora Pharmaceuticals will initially invest $50 million to acquire the CDMO assets of Eden Biologics in Taiwan. Taiwan-based contract development manufacturing organization (CDMO) Bora Pharmaceuticals has said it will initially invest $50 million and up to $100 million to acquire Eden’s CDMO assets. Through the acquisition, Bora will gain assets located in Hsinchu Biomedical Science Park, Taiwan. According to the CDMO, this will build and expand its presence in the biological macromolecule and cell…

May 13, 2022