Quality/GMPs

A new FDA guidance provides answers to such questions about when the agency will seek to visit a site during the COVID-19 pandemic and how it will respond when a needed inspection cannot be conducted safely.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

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.