BioPharm International-07-01-2020

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.

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.

Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.

Manufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.

The ISPE FOYA 2020 category awards included biologics facilities.

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.

Determining the root cause of out-of-specification (OOS) and other problems requires a careful, deductive approach and a clear understanding of processes.

483s and Warning Letters Point to Inadequate Quality Oversight

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Safeguarding against microbial contamination requires rapid detection and innovative technology.

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.

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

FDA can better monitor quality production of domestic versus foreign firms.

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.

AdvantaPure’s GORE STA-PURE Pump Tubing systems can now overmold into any manifold tubing assembly as its pump element.

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.

The LCMS-8060NX from Shimadzu is a triple quadrupole mass spectrometer that works to enhance method development and routine analysis.