BioPharm International
July 02, 2020
Cover Story: Process Control
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Manufacturers and the US government are investing heavily in traditional and non-traditional forms and materials to ensure supplies of containers and delivery devices for COVID-19 treatments and vaccines.
July 02, 2020
Development
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RNA is easier to manipulate than DNA but challenging to deliver to the right cells.
July 02, 2020
Upstream Processing
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Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
July 01, 2020
Downstream Processing
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Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
July 01, 2020
Manufacturing
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Manufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.
July 01, 2020
Manufacturing
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The ISPE FOYA 2020 category awards included biologics facilities.
July 01, 2020
Quality/Regulations
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Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.
July 01, 2020
Operations
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Determining the root cause of out-of-specification (OOS) and other problems requires a careful, deductive approach and a clear understanding of processes.
July 01, 2020
Quality/Regulations
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483s and Warning Letters Point to Inadequate Quality Oversight
July 01, 2020
Analytics
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Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
July 01, 2020
Analytics
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Safeguarding against microbial contamination requires rapid detection and innovative technology.
July 01, 2020
Operations
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The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.
July 01, 2020
Outsourcing
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The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.
July 01, 2020
From the Editor
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Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.
July 01, 2020
Regulatory Beat
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FDA can better monitor quality production of domestic versus foreign firms.
July 01, 2020
Ask the Expert
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It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.
July 01, 2020
Product Spotlight
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AdvantaPure’s GORE STA-PURE Pump Tubing systems can now overmold into any manifold tubing assembly as its pump element.
July 01, 2020
Product Spotlight
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The new Masterflex Flow Controller from Cole-Parmer measures, controls, and logs fluid path information after receiving input from a flow sensor and then modifies the speed of the pump to support a set flow rate or dispense volume.
July 01, 2020
Product Spotlight
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The LCMS-8060NX from Shimadzu is a triple quadrupole mass spectrometer that works to enhance method development and routine analysis.