Quality/GMPs

FDA approves Roche’s Phesgo, a Fixed-Dose Combination Breast Cancer Drug

July 01, 2020

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

FDA Issues Complete Response Letter to Allergan, Molecular Partners for Ocular Therapeutic BLA

July 01, 2020

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

Analytical Assays Determine Biosimilar Product Quality

July 01, 2020

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Detecting Microbial Contamination in Bioprocessing

July 01, 2020

Safeguarding against microbial contamination requires rapid detection and innovative technology.

Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow

July 01, 2020

Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.

Navigating Uncharted Waters

July 01, 2020

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

Eliminating Residual Impurities Starts with a Strategic Plan

July 01, 2020

Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.

Pandemic Spurs Efforts to Boost Pharma Manufacturing in US

July 01, 2020

FDA can better monitor quality production of domestic versus foreign firms.

Performing Remote Audits During the Pandemic

July 01, 2020

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.

Succeeding With OOS and Root-Cause Investigations

July 01, 2020

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.