Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Articles

Energy and water waste can be improved with new technologies, and sustainability can be considered in the design of new facilities. 

Improving Efficiency for Sustainable Pharmaceutical Facilities

Bioassays are critical for assessing potency and biological activity during biopharmaceutical activity, but they must be carefully designed to ensure reliability. Learn about new developments in cell-based bioassays and binding assays.


Frontiers in Binding Assays and Bioassays

A review of the market dynamics and drug development trends driving strategic outsourcing decisions.

Development trends driving strategic outsourcing decisions

Mahesh Kumar shares background, insights, and results of a study in which a relevant sensitivity and low positive control value in immunogenicity assays are identified.

Case Study to Demonstrate Sensitivity in Immunogenicity Assay Should be Based on Result of Both Screening and Confirmatory Tier

Study focused on demonstrating the effect of freeze-thaw of conjugated critical reagents on the binding capacity in immunogenicity assay performance.

Effect of Freeze-Thaw Cycles of Conjugated Reagents on Immunogenicity Assays

This paper answers a major concern of manufacturers: Do x-rays affect the quality and efficacy of a drug during product inspection?

Effects of X-ray Inspection of Pharmaceutical Products

This paper describes the existing regulatory framework for combined products and focuses on stability testing to assess drug or biological-device compatibility.

When Drug Meets Device

Advancements in Automated Visual Inspection Solutions

A core challenge among drug developers is working with challenging APIs, which are increasingly becoming more hydrophobic and/or with stronger crystal lattice structures, each ultimately poorly water soluble. This ebook covers a variety of important tools for formulators.


Strategies for Working with Poorly Water-Soluble APIs

Xavier Parissaux is Product and Project Manager at Roquette.

* Differentiate the suitability, quality and processability of an excipient.
* Recognize the significant impact of superior excipient processability.
* Understand the economic return associated with excipient selection.

All Whitepapers