Quality Control/Quality Assurance

Following Guidelines During a Crisis

June 02, 2020

Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Good Manufacturing Practices: Challenges with Compliance

June 01, 2020

The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

June 01, 2020

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Challenges, Tools, and Strategies for Data Integrity Protection

June 01, 2020

Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.

The Importance of Partnering for Bioanalytical Studies

June 01, 2020

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

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

May 07, 2020

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.

Building Better Bioassays

May 01, 2020

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

Shaping IR Spectroscopy into a Powerful Tool for Biopharma Characterizations

May 01, 2020

In this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.

Critical Knowledge for Preparing Audits

April 02, 2020

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Ensuring Smooth Tech Transfer of Bioprocess Operations

April 01, 2020

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.