11.16.23 -- FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

Have you considered the safety of your work environment’s air? Across industries, employers are determining how to detect inhalation hazards and, if present, how to protect employees from them.

Passive bulk shippers offer pharmaceutical companies solutions to the regulatory hurdles, supply chain disruptions, and logistical challenges inherent to global commercial pharmaceutical transport.

Lean construction, as a buzzword, gets a lot of play in the cleanroom industry for good reason. It is an idea that got its start with Toyota in the 1950s to maximize efficiency and eliminate waste in production.

Facilitating oligonucleotide synthesis with state-of-the-art equipment and process support is critical to maximizing oligo production and achieving consistency at scale.

By transitioning to alternative solvents or leveraging process aids, the challenges associated with the use of these chemicals can be addressed, helping create a sustainable and greener footprint.

Environmental monitoring (EM) should be performed using suitable techniques that meet the needs of the risk assessment. Learn about EM requirements, typical instrumentation features, and more.

Using transposon technology, a substantial improvement can be achieved by pseudo-targeting DNA cargos to integration sites where expression of recombinant proteins is likely to be higher in cells.

As patient centricity spurs innovation in drug delivery systems, examine the potential of FDCs to provide convenient dosing and how increased patient compliance is alleviating the cost of healthcare.

By partnering with a CDMO with experience in pediatric formulation, pharmaceutical companies can increase acceptability of their drugs among pediatric patients.

Explore a systematic thermal analysis approach for detecting drug-excipient incompatibility. The proposed method uses the approach of apparent melting and provides a rapid screening protocol.

In this study, two different immune cell preparations were evaluated for their compatibility with the Milliflex Rapid System to establish a USP- and EP-compliant method for rapid sterility testing.

See how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility.

Controlling water content in oral solid dosage (OSD) products is essential to maintain drug efficacy and safety. Learn about water activity determination of OSD products as well as USP <922>.

Discover how revolutionary and environmentally sustainable nanoparticle technologies coupled with innovative formulation approaches can address drug solubility issues and add value for patients.

How do you know if an intensification approach will provide advantages? Three process intensification experts show how different intensification approaches affect outputs using different scenarios.