Tuesday, May 31, 2022 Daily Archives

Leveraging NISTmAb Prior Knowledge to Demonstrate Analytical Competency

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The NISTmAb IgG1κ monoclonal antibody reference material, from the National Institute of Standards and Technology, is intended for use in evaluating the performance of analytical methods that determine physicochemical attributes of biologics. As a case study, Almac Sciences have assessed NISTmAb and its prior knowledge to demonstrate competency in chromatography and capillary electrophoresis methods. Key Takeaways: Analytical challenges during establishment of NISTmAb methods. Comparability assessment of NISTmAb data to demonstrate analytical competency. Transition of capillary electrophoresis methods from 32Karat software…

May 31, 2022

eBook: A Dynamic Control Strategy for Downstream Continuous Bioprocessing

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Continuous processes can have many sources of variability. In downstream unit operations, changes can arise because of feed material variability, resin fouling in chromatography columns, column compression or failure, membrane fouling, depth-filter clogging, and so on. The US Food and Drug Administration’s guideline for continued process verification encourages biomanufacturers to monitor their processes and keep them under a steady state of control. One way to achieve that in continuous downstream processes is to implement a dynamic control system that adapts…

May 31, 2022

Evotec expands cell therapy capabilities with Rigenerand buy

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Evotec says the $23 million acquisition of Rigenerand will support its iPSC platform and add cell therapy manufacturing experts to its team. According to the firm, it will gain Rigenerand SRL’s manufacturing site in Medolla, Italy,  around 100 kilometres south of Evotec’s campus located in Levi-Montalcini in Verona. Evotec claims the addition of the Medolla facility will expand its cell therapy platform Evo cells as it provides them with inhouse capabilities and a “high-quality” production site. “The manufacturing capability of…

May 31, 2022

GSK boosting vaccine tech through $2.1bn Affinivax buy

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The planned acquisition will add Affinivax’s Multiple Antigen Presenting System (MAPS) to GlaxoSmithKline’s technology portfolio along with a pneumococcal vaccine candidate. Announced this morning, the proposed deal will see GlaxoSmithKline (GSK) pay $2.1 billion upfront for Massachusetts-based vaccine developer Affinivax. The Big Pharma firm could pay a further $1.2 billion in potential development milestones. Affinivax’s lead candidate AFX3772 is set to enter Phase III trials for pneumococcal diseases, which include sepsis, pneumonia, meningitis, and others caused by the bacterium Streptococcus…

May 31, 2022

Jubilant HollisterStier to double filling capacity in US Gov pact

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Jubilant has entered into for a $149 million agreement with the US Government to double its injectable filling capacity at its Washington state plant. Through its subsidiary Jubilant HollisterStier, Indian firm Jubilant Pharmova will support the US in expanding its vaccine manufacturing capacity. The agreement is in cooperation with the Army and Contracting Command, the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA). The $149…

May 31, 2022