Quality/GMPs

As biopharma companies and research institutes advance the development of COVID-19 vaccines, policy makers and health officials are debating strategies for ensuring fair and equitable distribution of anticipated preventives.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

Process modeling offers an opportunity to troubleshoot for and anticipate difficult aspects of a bioprocess.

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

Time sure flies, except when you are waiting for something to happen.

When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?

Industry should be seeking more information from FDA on how it will restart its current inspection program.

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

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

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

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

Determining the root cause of out-of-specification (OOS) and other problems requires a careful, deductive approach and a clear understanding of processes.

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

Safeguarding against microbial contamination requires rapid detection and innovative technology.

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.

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

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

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

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