08.04.22 -- 3-Step Strategy For A Successful Drug Candidate

For fiscal year 2020, the most common FDA inspectional observations for biologics, devices, and drugs involved SOPs. To avoid a warning letter from the FDA, life sciences companies need a methodical approach to their SOPs.

The bioprocess boom of 2020, which continues unabated, has attracted many players into this space. More and more integrators are entering the market, one that's far from easy to master.

As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

Regular assessments of a partnership’s value in terms of supply chain, operational efficiency, data analysis, and more can optimize and extend the product life cycle.

Review a few misconceptions about collaborating with Pfizer CentreOne and how they align with the values – courage, excellence, equity, and joy.

As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

Transdermal drug delivery (TDD) can offer constant drug levels, reduced dose frequency, and a noninvasive procedure that can be self-administrated. See how this technology has been driving the development of new drugs.

We discuss the three general BI types used for monitoring the VH₂O₂ cycles and directions on their proper placement in the isolator.

Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.

A leading biotech company working in the targeted protein degradation space was looking for fast delivery of the compounds, open, transparent, and on-time communication, and flexibility and ability to scale.

Pierre Catignol and Huisub Lim share their insights on current mRNA market trends, manufacturability, choosing an appropriate CDMO partner, and mRNA technology considerations.

Gain insights from a pharmaceutical equipment manufacturer on factors cannabis manufacturers should consider when they're looking to purchase a mixer.

Good technique when working within a Class II biosafety cabinet (BSC) will minimize air turbulence and prevent splatter or unwanted spread of aerosols.

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.

Explore options for the field of chromatography and allied downstream technologies and how these technologies are applied to design favorable processes in order to generate true customer benefit.

Learn more about understanding the process robustness and vessel capability’s role in a seamless system transfer and S.U.B. process comparability.