Friday, April 8, 2022 Daily Archives

Developing Methods for Comparability Studies of Therapeutic Monoclonal Antibodies: Minimize Time, Maintain Quality

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This webcast features: Kalhari Silva, PhD, Head of Scientific Research, Custom Biologics, and Bob Dass, PhD, Senior Scientist, Octet Applications, Sartorius. Quantifying critical quality attributes accurately and precisely is an important aspect of regulatory compliance. There is greater demand to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy of biotherapeutics. Kalhari Silva, from Custom Biologics, will provide insight on how her team designs and establishes methods suitable for comparability studies that allow for their future…

April 8, 2022

Lab Scale Depth Filtration with FILTROSPIN™ 20

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FILTROSPIN™ 20 by FILTROX enables you to quickly and efficiently test different depth filters or quickly purify a small amount of liquid. The filters are inserted into standard 50 mL centrifuge tubes (Labcon® SuperClear® 50 mL tubes). The liquid is then filtered using a centrifuge or vacuum. In order to evaluate the most suitable and optimized production process, small-scale trials are the key factor to start with. With the help of laboratory scale trials, errors and other issues can be…

April 8, 2022

Lonza adds magnetic cell selection to Cocoon platform

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Lonza has expanded its Cocoon platform functionality by adding capabilities in cell separation, cell binding, and bead removal. The Cocoon platform is a single system that can be used for a wide-range of different autologous cell therapy protocols, with each patient batch produced in a single disposable cassette customized to their specific process. The platform was developed by Octane Biotech with help from Swiss contract development manufacturing organization (CDMO) Lonza, which has worked with the firm since 2015. In October…

April 8, 2022

Alnylam RNAi candidate delayed due to packaging CDMO issues

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Alnylam says an inspection at a secondary packaging facility run by a third-party has pushed the FDA’s approval date for vutrisiran back three months. Alnylam Pharmaceuticals is a pioneer in the RNAi space, becoming the first company to bring a small interfering ribonucleic acid (siRNA) treatment to the market with Onpattro (patisiran), approved by the US Food and Drug Administration (FDA) in August 2018. Since then, the firm has achieved success with Givlaari (givosiran) and Oxlumo (lumasiran) but has suffered a…

April 8, 2022

Cash strapped Bluebird cuts staff and focuses on late stage gene therapies

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Bluebird Bio is cutting its workforce and prioritizing late phase gene therapy projects to reduce costs. The US biotech announced the staff cuts this week, explaining the aim is to deliver up to $160 million in operational savings over the next two years. It did not share further details. At the start of the year, Massachusetts-based Bluebird said it employed 518 people, 330 of whom work in R&D with 188 engaged in commercial, finance, legal, business development, human resources, information technology,…

April 8, 2022