Search results for "regulatory"
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High-Throughput Process Development Handbook
In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. Employing high-throughp…
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Continuous Processing for the Production of Biopharmaceuticals
There have also been new efforts by various regulatory organizations to encourage continuous processing for the manufacturing of biopharmaceuticals. Both FDA and the European Medicines Agency (EMA) ha…
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Biomanufacturing Outsourcing Globalization Continues
These CMOs continue to face domestic regulatory and legal hurdles, and are far from obtaining approvals for US and EU markets. Perceived cost-effectiveness offered by CMOs in these markets may be erod…
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Relationship Building at Top of Mind for Clients
…city and Production (1) show, however, it’s no longer enough for CMOs to lay claim to technology, regulatory compliance, and IP protection expertise, as these increasingly become non-negotiable issue…
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Single-Domain Antibodies for Brain Targeting
Immunogenicity concerns in relation to these strategies are still under investigation by drug regulatory agencies. Favorable properties, such as good expression, thermal stability, and solubility, are…
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Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
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Trends in BioPharma Approvals in 2013
Several of those newly approved products underpin particularly noteworthy technical, medical, or regulatory milestones, and are thus the focus of the remainder of this article.
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Outsourcing Trends in Biopharmaceutical Manufacturing
Other problems can arise, such as a lack of consistency in bioprocessing and regulatory documentation, which in turn lead to delays in product development, approvals, and manufacturing.
Trend eigh…
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Drugs, At What Cost?
…ernment austerity programs, blockbuster drugs falling off the patent cliff, and varying medical and regulatory practices worldwide continue to shape the financial outlook of biopharmaceutical compani…
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Trends in Downstream Bioprocessing
These persistent capacity issues could be related to a reluctance on the part of product developers to modify legacy processes, with these developers harboring regulatory concerns that hold them back …