Search results for "biotech" in Articles / App Notes
Article
Addressing the Complex Nature of Downstream Processing with QbD
When it comes to early development, Doug MacDonald, senior scientist at Seattle Genetics, a biotech company that develops and commercializes cancer therapies, states that “speed to clinic” can inhibi…
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Andy Racher, associate director future technologies, Lonza Pharma & Biotech. Today, however, cell titers have been reported at levels in excess of 10 g/L, he says.
This resulted from the introd…
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Biopharma Seeks Balance
According to a Biotechnology Innovation Organization report (1) overall investment trends for R&D-stage companies were up in 2017 compared with 2016, despite a drop in the number of acquisitions. Gile…
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Applying GMPs in Stages of Development
This procedure, regardless of whether the product you are investigating is biotech or traditional, or new or old, should require the investigator to review various systems and determine whether they w…
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FDA Framework Spurs Advanced Therapies
… and gene therapies,” observes Alison Keene, head of global regulatory affairs for the pharma and biotech segment of the company. “We welcome the progressive regulatory approach FDA is adopting, whic…
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Continuous Processing for the Production of Biopharmaceuticals
With the growing demand for biosimilars and an ever-increasing pressure for reduction in manufacturing costs, the biotech industry seems to exhibit a flourishing interest in the development of continu…
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Biopharma Advances Demand Specialized Expertise
Lorimer (Patheon Biologics): The trend of small biotech partnering with large pharma for clinical manufacturing and development has certainly facilitated the full development of more novel molecules. …
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Quality Systems Key to Lifecycle Drug Management
Post-approval changes for biotech therapies will continue to be managed by OPQ’s Office of Biotechnology Products.
A smooth hand-off from new drugs to lifecycle is important, commented ONDP acti…
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Biomanufacturing Outsourcing Globalization Continues
For example, Cytiva built two facilities in China for CMO JHL Biotech, including a KUBio modular biopharma factory in Wuhan that will house 2000-L single-use bioreactors (4). Pall Corp. opened its Lif…
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Re-use of Protein A Resin: Fouling and Economics
Thus, Protein A is considered to be the most crucial step in the purification process and a major contributor towards achieving the stringent purity levels expected of biotech therapeutics with HCPs r…