Pharmaceutical Technology-07-02-2020

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

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

Demand for custom drug delivery solutions is increasing and bringing forth an exciting period of valuable, innovative development opportunities.

There is much to learn from the COVID-19 pandemic, but future success may hinge upon the capacity for regulatory bodies to harmonize approaches.

EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.

Controlled-release formulations offer numerous advantages for developers and patients, and this market is expected to continue to experience growth in the near future.

COVID-19 vaccines are being developed rapidly, giving rise to a reinvigoration of the sector.

As Brexit talks intensify, bio/pharma companies from both the UK and EU need to consider and aim to prepare for all scenarios.

Using a specific addition method to wet the powder bed in twin-screw granulation using a foam binder improves robustness for continuous solid-dosage drug product manufacturing.

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

FDA Commissioner Hahn commits to a science-based review and approval process.

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

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

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

The Double Planetary Mixer from Ross is scalable through 1000-gallon production models and is offered in a sanitary turnkey configuration that features a stainless-steel workbench for the mixer and discharge system.

Cherwell Laboratories expanded its line of stainless-steel prepared media accessories for cleanroom monitoring programs with its new floor standing settle plate stand.

483s and Warning Letters Point to Inadequate Quality Oversight

Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.

The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.

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

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