Pharmaceutical Technology, September 2022

The flow of capital and scientific acuity irrigates this pharm system.

Biopharmaceutical manufacturers must consider a surprisingly wide range of factors when deciding where to turn for assistance with cell line development.

It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.

Expanded use of data analytics can help to avoid disruptions, but the possibilities cannot be realized without sufficient investment and direct human involvement.

API permeation into the skin modulates the efficacy of topical treatments.

It is possible to overcome some of the limitations of traditional dosage forms by employing alternative drug delivery formulation strategies.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

Cleanroom monitoring may be in a state of flux after many recent technological advancements.

By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

EMA has announced a change of plan for the IDMP.

More than anything else MonkeyPox and COVID-19 have shown that we are interdependent, no matter what continent you call home.

A new unitary patent system is due to come into effect in Europe later on this year.

As winter approaches, the next generation of COVID-19 vaccines are being prepared and scheduled, ready for distribution across Europe and the world.

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.

The ROSS Vertical Blender enables mixing of friable solids.

Shimadzu’s Nexera XS inert is designed to prevent both adsorption of target molecules to metal surfaces and mobile-phase corrosion.

Cellefill is a vial fill/finish system that designed to promote flexibility via an integrated barrier solutions.

Qosina’s AseptiQuik STC Series enables flexibility between hybrid stainless steel and single-use processing equipment.

While the cost of certain medicines are alarmingly high, they can be considered a bargain measured against a lifetime of traditional costs.