This market research report provides an overview of the current biologic sterile injectable market dynamics as well as what our survey respondents — all outsourcing decision makers — predict the market will look like in 2022. Key statistics include development-stage and marketed product volume, the proportion outsourced, and the number of CMOs required to complete the work. You can purchase the report or download a free preview by clicking here.
By Louis Garguilo, Chief Editor, Outsourced Pharma
Robert Ward of Eloxx Pharmaceuticals is on his second tour of duty as chief executive officer of an early-stage biotech. That makes him the perfect “real-life” CEO to react to a recent editorial about a “speculative” CEO who says to her colleagues: “We outsource, therefore we exist.” Ward’s initial thought? “Don’t put Descartes before the horse."
This article is the first part of two-part article that will discuss objectionable microorganisms recovered from nonsterile products. In this part, we will explore what constitutes an objectionable microorganism, as well as the regulatory expectations for objectionable microorganisms in nonsterile products.
The emulsion system created when forming microparticles can quickly become complex. Following are critical factors to consider when beginning work with microparticle formulation for a large protein molecule.
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By Andrew Chang, Ph.D., Novo Nordisk Quality, Novo Nordisk Inc.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC (chemistry, manufacturing, and controls) changes effectively under a company’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.