Monday, December 16, 2019 Daily Archives

Analytical Testing Strategies for CAR T-Cell Products

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Assay lifecycle development for traditional biopharmaceuticals such as vaccines and monoclonal antibodies (MAbs) has a clearly defined pathway, from preclinical method selection, development, and optimization through the milestones in preclinical phase trials, and finally to postlicensure method evaluations, comparability, and improvements. The analytical development roadmap for nontraditional biologics such as chimeric antigen receptor (CAR) T-cell therapies and gene therapies are not as clearly defined and can present many challenges along the way. Understanding the “what, how, and when†of analytical…

December 16, 2019

Measure Twice, Treat Once: Navigating the Regulatory Landscape of Assay Development to Ensure High-Quality CGT Products

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Cell and gene therapies (CGTs) are a novel and fast-growing class of transformative therapies designed to address gaps in traditional treatment strategies of some of the most severe diseases. By definition, gene therapy “seeks to modify or manipulate expression of a gene to alter the biological properties of living cells for therapeutic use†(1). That can be either an in vivo delivery of a gene or delivery of a gene to a patient’s cells that are manipulated outside of the…

December 16, 2019

Monoclonal Antibody Aggregate Polish and Viral Clearance Using Hydrophobic-Interaction Chromatography

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Hydrophobic Interaction chromatography (HIC) is a powerful polishing tool for the downstream purification and manufacture of biotherapeutics. HIC offers orthogonal selectivity for the clearance of difficult process and product-related impurities such as aggregates, host cell proteins and endogenous and adventitious viruses.  In this study, a family of POROS HIC resins with novel ethyl and benzyl chemistries was used to successfully polish two clinical stage monoclonal antibodies harboring very high levels of product aggregation (>10%). In addition to aggregate removal, viral…

December 16, 2019

Risk and Lifecycle Management for Biopharma Operations

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By working with the best biopharmaceutical companies for over a decade, 4Tune Engineering (4TE) has built a portfolio of services that enables companies to address current-century challenges. The biotechnology industry needs to address advanced therapies and personalized medicines and deliver explicit patient outcomes. Biologics today fall into four categories: monoclonal antibodies (MAbs), biosimilars, advanced therapeutic medicinal products (ATMPs), and cell and gene therapies (CGTs). Consequently, we can ask whether our manufacturing science and technology (MSAT) approaches are up to the…

December 16, 2019

AAV Vector Manufacturing Platform Selection and Product Development

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Adenoassociated virus (AAV) vectors have emerged as the prominent delivery mechanisms of corrective gene therapies. Three such products — Glybera (alipogene tiparvovec, uniQure), Luxturna (voretigene neparvovec-rzyl, Spark Therapeutics), and Zolgensma (onasemnogene abeparvovec-xioi, AveXis) — have been licensed, and a growing number of candidates are entering late-stage development. In mapping out an AAV gene therapy product development strategy, biomanufacturers should address fundamental considerations for their manufacturing strategies for both phase 1–2 clinical evaluation and translation for commercial market supply. A manufacturing…

December 16, 2019

Samsung BioLogics brings Berkeley Lights’ Beacon to Korea

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Korean CDMO Samsung BioLogics will use the Beacon optofluidic platform to reduce cell line development timelines and boost its drug development services. Having first entered the contract development space in 2017, Samsung BioLogics has now inked a deal to use Berkeley Lights’ Beacon pre-programable and automated optofluidic platform to service its customers cell line and process development projects. The technology itself is based on a nanofluidic chip consisting of chambers in which cells are placed to be cultured and assayed,…

December 16, 2019

WuXi Biologics establishes microbial fermentation in latest expansion

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Having rapidly built up its mammalian biomanufacturing network, WuXi Biologics says it will now add microbial fermentation to its CDMO offering. At the end of October this year, Chinese contract development and manufacturing organization (CDMO) WuXi Biologics announced its latest financing round with intentions to raise roughly HK$3,950 million ($500 million). The supporting document states: “The Company intends to apply the net proceeds from the Primary Placing to support its development of vaccines and microbial based products as well as…

December 16, 2019