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BioPharm International-07-01-2020
BioPharm International
COVID-19: Shoring Up the Drug Delivery Infrastructure
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.
Can Using RNA Simplify Gene Therapy Development?
July 02, 2020
Development
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RNA is easier to manipulate than DNA but challenging to deliver to the right cells.
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
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.
Eliminating Residual Impurities Starts with a Strategic Plan
July 01, 2020
Downstream Processing
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Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy Facilities
July 01, 2020
Manufacturing
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Manufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.
ISPE Facility of the Year Awards Recognize Innovative Biologic Manufacturing Facility Designs
July 01, 2020
Manufacturing
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The ISPE FOYA 2020 category awards included biologics facilities.
Succeeding With OOS and Root-Cause Investigations
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.
Investigating an OOS in a Biosafety Cabinet
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.
Solving Pharma’s Quality Unit Identity Crisis
July 01, 2020
Quality/Regulations
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483s and Warning Letters Point to Inadequate Quality Oversight
Analytical Assays Determine Biosimilar Product Quality
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.
Detecting Microbial Contamination in Bioprocessing
July 01, 2020
Analytics
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Safeguarding against microbial contamination requires rapid detection and innovative technology.
Minimizing Contamination During Biopharma R&D
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.
Contractors Balance Increased Demand During COVID-19
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.
Navigating Uncharted Waters
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.
Pandemic Spurs Efforts to Boost Pharma Manufacturing in US
July 01, 2020
Regulatory Beat
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FDA can better monitor quality production of domestic versus foreign firms.
Performing Remote Audits During the Pandemic
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.
Pump Tubing System
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.
Lightweight Flow Controller
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.
Triple Quadrupole Mass Spectrometer
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.