Quality Systems

Articles

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

The Importance of Partnering for Bioanalytical Studies

Survey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.

USP Novel Excipients Survey: Stakeholders’ Views on the Current State of Excipient Innovation

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination. 

Minimizing Contamination During BioPharm R&D

The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.

HPRA Grants IMP License to Wasdell Group

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.

Considerations in Contamination Control

Pharmaceutical Technology spoke with John Harmer, director, technical sales at Vanrx Pharmasystems about considerations in choosing the best system and equipment for contamination control in pharmaceutical manufacturing.

Best systems and equipment for contamination control

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

Detecting Contamination in Cell Therapies

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Some observers fear that political interference in the process may erode confidence in the scientific basis for FDA regulatory decisions. 

FDA’s Emergency Use Process Under Scrutiny

A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.


EMA Commences Rolling Review of Remdesivir Data as COVID-19 Treatment

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.


Quality Assurance/Quality Control