Monday, March 14, 2022 Daily Archives

Continuity of Methods: Characterizing Protein Therapeutic Stability From Developability Assessment to Release With Aura PTx

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This webcast features: Bernardo Cordovez, CSO, Co-Founder, Halo Labs. Aura PTx is a complete protein therapeutic stability solution that enables characterization of subvisible particle aggregates from developability assessment through product release. Aura PTx is a high throughput analytical instrument that images, counts, sizes, and identifies subvisible particle aggregates, a critical quality attribute and the most important biologic stability parameter. Using volumes as low as 10 µL and with measurements of one minute per sample, Aura PTx enables rapid, highly contrast and…

March 14, 2022

Sustaining Project Management Business Continuity and Partnerships Throughout COVID

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This webcast features: Patrick Haley, Sr. Director, Project Management & Business Operations, Avid Bioservices, Inc. The Avid project management office employed unique technology and communication techniques to maintain business continuity and material supply to our partners and the patients they serve throughout each COVID surge. This presentation will take a deep dive into the challenges and solutions encountered for each functional area in the biologics development and production process during the early COVID pandemic and later surges, while ultimately discussing…

March 14, 2022

Autologous CAR T-Cell Manufacturing Using a Semi-Automatic, Closed, Modular Workflow

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There have been tremendous efforts to make CAR T-cells more effective, safe, and persistent when treating patients. On the manufacturing side, however, errors, lot-to-lot variation, and contamination can be associated with open processes and manual handling of CAR T-cells. Cell isolation, gene editing, expansion, and cryopreservation are complex steps in a typical autologous CAR T-cell manufacturing process. Integrating this complicated multistep workflow into a closed, modular, benchtop system can facilitate transitions from laboratory scale to clinical manufacturing and improve the…

March 14, 2022

AI start-up explains why protein engineering (Bio)matters

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BioProcess Insider spoke with Biomatter Designs founder and CEO Laurynas Karpus to discuss the Lithuanian-born start-up and its future. Founded in 2018, Biomatter Designs aims to shift the field of protein engineering by producing a platform for generative protein design for next-generation manufacturing and therapeutic applications. BioProcess Insider (BI): How would you describe Biomatter Designs? Laurynas Karpus (LK): Biomatter Designs is a biotech company striving to shift the paradigm in the field of protein engineering by developing a platform for…

March 14, 2022

UCB invests $221m to construct a gene therapy facility

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UCB will construct a gene therapy and clinical manufacturing plant at its campus in Braine l’Alleud, Wallonia, Belgium. According to UCB, the evolution of the gene therapy space has altered how diseases are being treated but the production of viral vectors remains a consistent challenge because of the complex manufacturing process. Therefore, developing capabilities and flexible manufacturing is critical to succeeding in the gene therapy industry. To establish an end-to-end process, Belgium’s biggest drug maker has decided to invest more…

March 14, 2022

Cytiva pumps further $47m into Welsh single-use site

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Cytiva is opening a facility in Cardiff, Wales to produce single-use bioprocessing technologies on the back of global demand. The 11,000 m² Cardiff facility is part of the $1.5 billion investment announced in July 2021 to expand manufacturing capacity for life sciences products at thirteen Danaher Corporation sites run by Cytiva and Pall to meet customer demand. Over two years, the company will invest £36 million ($47m) into the expansion at the Cardiff site, which has already begun to make flow…

March 14, 2022

Novartis playing in cell therapy CDMO space with Carisma

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Novartis will make a macrophage-based cell therapy targeting breast cancer for Carisma Therapeutics from its Morris Plain, New Jersey site. An initial agreement signed this week will see Novartis manufacture a HER 2 targeted CAR-Macrophage (CAR-M) cell therapy for Carisma from the beginning of 2023. The candidate, CT-0508, is the first CAR-Macrophage cell therapy to enter clinical trials. Preclinical trials have shown the potential to overcome key challenges faced by other cell therapies treating solid tumors, including: The capacity to…

March 14, 2022