Search results for "regulatory" in Articles / App Notes
Article
Driving Change in Biomanufacturing
The new technology must be fully understood, all regulatory requirements fulfilled, the quality of the product output secured, and a thorough risk mitigation conducted.
The large buffer volumes …
Article
The New World of Biopharmaceutical Manufacturing
Part of this persistent concern for L&E issues is the increased use of disposables, which, in turn, has increased awareness of the uncertainties regarding related regulatory issues.
Pora …
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N-Glycan Analysis of Biotherapeutic Proteins
Future directions in N-glycan analysis
As glycosylation is a frequently monitored CQA of biotherapeutics, there will likely be increasing regulatory pressure to control processes for better …
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Unifying Continuous Biomanufacturing Operations
The researchers wrote, “The enhancement of product quality compared to fed-batch is indeed the most relevant one in a regulatory perspective. The stable operation at steady state and the short residen…
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Downstream Processing for Cell-Based Therapies
As volumes and cell densities increase upstream, and regulatory requirements for target product profiles become more stringent, the need for efficient, highly specific, scalable DSP techniques grows. …
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HTPD: Optimizing a mAb Chromatography Polishing Step
In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. High-throughput process…
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The Tide Stays High
US election impacts
Clearly, general economic sentiment since the November 2016 presidential election has been positive, with an expectation that the regulatory environment will be less restrictiv…
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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…