BioPharm International-12-01-2018

This research proposes a method for separating and purifying tissue-type plasminogen activator from a fungal cell source.

Unprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.

CMOs and CDMOs made investments in new and expanded facilities and services in the last quarter of 2018.

Success depends on supplier communication and transparency, but it’s up to buyers to demand the right information and to look at the vendor’s overall business.

Click the title above to open the BioPharm International December 2018 issue in an interactive PDF format.

Fluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.

Innovation may capture headlines, but quality programs are the foundation to biopharma success.

Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.