Search results for " biotech"
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FDA Framework Spurs Advanced Therapies
…l 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, whi…
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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…
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Biopharma Manufacturers Respond to Ebola Crisis
Vaccine industry executives and biotech innovators joined the discussion about conducting effective and ethical clinical trials and ramping up production of promising vaccines and therapies. A main ai…
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Biotechnology Innovation and Growth in Israel
Moreover, according to Benny Zeevi, co-chairman of the Israel Advanced Technology Industries (IATI), Israel’s flourishing biotechnology industry is transitioning from a period of incubation to one of …
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Regulatory Challenges in the QbD Paradigm
Review and inspection responsibilities are shared between the Office of Pharmaceutical Science/Office of Biotechnology Products (OBP) and the Office of Compliance/Office of Manufacturing and Product Q…
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Bracing for a Future Wave of Advanced Therapies
…rtnership among the Centers for Medicare & Medicaid Services (CMS), state Medicaid agencies, and biotech companies. From these partnerships, outcomes-based agreements (OBAs) can be set up and adminis…