Pharmaceutical Technology-02-02-2021

New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?

This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.

Plasma-based proteins and cell-based therapies have significant potential to address unmet medical needs.

Rapid growth in biologics and increasing complexity of new compounds are some of the factors driving development of innovative delivery solutions.

Advanced manufacturing technologies are available, but challenges need to be addressed.

Sharing process insights across the stages of drug development improves tech transfer.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.

Anticounterfeiting technology protects the supply chain from manufacturer to patient.

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.

More work is needed to educate businesses on the value of innovation and the availability of funding.

FDA puts applications on hold as the agency limits alternative oversight methods.

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

COVID-19 vaccine supplies are breaking news headlines, in both ‘good’ and ‘not so good’ ways.

Viewpoint: Mike Hennessy, Sr., founder and chairman of MJH Life Sciences, commends the leadership of the pharmaceutical industry in combatting the COVID-19 pandemic.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding regulatory inspections, although many of the concepts can be applied to internal and supplier audits as well.

A complicated vaccination rollout and mixed messages may derail the pandemic endgame.

Romaco Innojet’s IGL 100 granulation line is intended for production-scale processing applications and combines high-shear mixing and granulation, fluid bed drying, fluid bed granulation, fluid bed pellet coating, and fluid bed hot melt coating into one unit.

Advanced i-Series liquid chromatographs from Shimadzu provide users with the ability to analyze a large number of samples and re-process data while working remotely.

The GENiSYS R from AST (pictured) is a modular system that automates aseptic filling and the closing of vials, syringes, and cartridges.

ROSS incorporated a high shear rotor/stator into its Dual-Shaft Mixer to meet more intense shearing and homogenization requirements.