Manufacturers of Biologics to Increasingly Use Single-Use Technologies

Biologics manufacturing facilities using traditional stainless-steel bioreactors have to deal with significant manufacturing suite unavailability between production cycles due to expensive cleaning technology, extensive cleaning validation, and the associated loss of productivity and revenue. The use of single-use and disposal technologies such as single-use bioreactors (SUB) can greatly increase the production efficiency by reducing the … Read more

SOP Deficiencies and Documentation Errors Dominate EMA GCP Audit Findings

In a report released by European Medicines Agency (EMA) earlier this month, auditors from the Agency found many clinical sites to have several major deficiencies in compliance with Good Clinical Practices (GCP). About 58% of the findings related to errors in study documents, either poor source documents or bad documentation practices, while about 15% findings were related … Read more

Should Prescription Drugs Cost be Controlled in the US?

The public opinion in the US is getting increasingly negative for the high prices of prescription drugs. A course of treatment for some hepatitis drugs could cost $95,000; multiple cancer drugs cost about $150,000 per course, while a couple of drugs for the rare disease cystic fibrosis could cost more than $300,000 for a single course of … Read more