BioPharm International-06-01-2019

CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.

FDA’s annual manufacturing report card shows more quality compliance is needed.

The learning curve for process analytical technology has slowed widespread adoption.

As cost and time pressures within biopharma are on the rise, innovative expression systems may offer companies a good opportunity to streamline processes early on.

Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Quality by design brings both challenges and benefits to the development of downstream processes.

BioPharm International speaks with several experts to learn more about pipeline platforms and technologies.

Click the title above to open the BioPharm International June 2019 issue in an interactive PDF format.

The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.

Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.

Stuart Jones, regulatory quality assurance professional in good laboratory practice (RQAP-GLP) and director of quality assurance at PPD Laboratories’ Bioanalytical Laboratory shared GLP best practices with BioPharm International.

Research advances have enabled the application of nanotechnology to drug delivery. What does this technology offer in the way of enhancing therapeutic effect?

This article explores the challenges and potential of next-generation therapeutic antibodies.