BioProcess Online caught up with Dr. Loretta Itri, veteran CMO at Immunomedics, fresh on the heels of her 18th drug approval. The ensuing conversation on her mastery of the multifaceted role serves as a blueprint for aspiring chief medical officers.

This case serves as a reminder that sometimes it is impossible to fully evaluate the likelihood of success in biosimilar litigation before the challenge begins.

Performing virtual FATs (vFATs) can be a helpful solution in these new and uncertain times, though it does come with added risk. Without having the team on-site, remote FATs present a higher possibility for equipment to be shipped without meeting the end user’s requirements and functional specifications.

The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.

A virtual company advancing a drug candidate into product development faces a deluge of challenges. The reality is you do need the assistance of pharmaceutical scientists and advice from industry professionals to help you navigate the twists and turns in the road.

Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.

Many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies.

Which CDMO characteristics do experienced outsourcers value the most when choosing a CDMO for biologic API production? Data from the past three iterations of ISR’s Bioprocessing Market Trends and Outsourcing Dynamics show the top selection metrics remain cosnsistent despite some shifts in ranks over the years. Learn which attributes to focus on as a sponsor or CDMO.

It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.