Monday, November 8, 2021 Daily Archives

Why Choose Eurofins BioPharma Product Testing?

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For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing offers comprehensive, fully CGMP-compliant Viral Clearance Services. We have two dedicated clearance suites for extensive capacity and timely execution and reporting of your study results. And all of our assays are fully validated to meet ICH Q2 requirements. Why Choose Eurofins BioPharma Product Testing? We bring together leading experts in the industry with extensive scientific and regulatory experience. By supporting you from study…

November 8, 2021

The Viscosity Reduction Platform: Viscosity-Reducing Excipients for Protein Formulation

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Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous (subQ) injection. Highly viscous protein solutions would require a significant force to be applied to the syringe for injection. As a result, the patient could experience a considerable amount of pain. In many cases, injectability would not be possible. When characterizing protein viscosity behavior, one can differentiate two different concentration regimes. At very low concentrations below about 75 mg/mL, proteins are rarely viscous.…

November 8, 2021

Aragen focuses on securing biologics capacity within ‘competitive’ CDMO space

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Longer-term funding in biotech has led to deeper partnerships with CDMOs says Aragen Bioscience, which is looking to establish its own biomanufacturing capabilities in the US. Through investment from parent firm GVK Bio, contract research organization (CRO) Aragen has grown its business to include two sites in San Francisco offering efficacy studies, protein analytics, and cell line development services. But for several years, the company has looked to enter the contract development and manufacturing organization (CDMO) space, firstly by adding master…

November 8, 2021

Ins and outs: Avid create viral vector position to lead CGT expansion

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CDMO Avid Bioservices has appointed Elie Hanania as vice president, process development, viral vector technologies to lead the company’s efforts in the CGT space. Sit back, relax, and enjoy this week’s Ins and outs. Biologics contract development and manufacturing organization (CDMO) Avid Bioservices turned to the production of viral vectors in October with plans to build a 53,000 square foot viral vector development and GMP manufacturing facility in Costa Mesa, California at a cost of around $75 million. Now, with…

November 8, 2021

Podcast: Life beyond Provenge as Dendreon enters CDMO world

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As Dendreon secures its first manufacturing deal, we speak with VP of corporate strategy about the firm’s new direction in the cell therapy CDMO space. Dendreon Pharmaceuticals will provide process development, end-to-end logistics, and scalable cGMP manufacturing support for Shoreline Biosciences’s pipeline of allogeneic natural killer (NK) and macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC). Financials have not been disclosed but the deal marks the first contract announced by Dendreon since it relaunched itself as a contract…

November 8, 2021