Industry Insights

1. Congressional Bill Supports Advanced And Continuous Manufacturing 1/5/2022

   The House recently passed H.R. 4369, which authorizes $100 million over four years to establish National Centers of Excellence in Advanced and Continuous Manufacturing at U.S. academic institutions. This article delves into the news and how it fits into other U.S. initiatives supporting the field.

2. Choosing The Right PBMCS For Your Research And Product Development Needs 6/10/2025

   Enhance the success of your research and cell therapy programs by sourcing PBMCs with proven functional performance and donor-specific insights.

3. Tips For Your Virtual Meetings With The FDA 10/7/2022

   It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.

4. Determining Significant Vs. Nonsignificant Risk In Medical Devices 5/24/2018

   Knowing how to classify your device as either SR or NSR is not a clearly defined task. There are implications for each decision made as you proceed through development, and the burden is on you to understand and to provide what the FDA will require.

5. The Promise And Paradox Of QbD 11/24/2025

   The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms.

6. How To Find & Manage Biotech Consultants Effectively 9/6/2021

   The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

7. Engineering E. Coli For Novel Biopharmaceutical Manufacturing 9/3/2024

   Recent advancements in genetic engineering and analytical techniques have significantly enhanced E. coli's potential for protein expression.

8. A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers 4/19/2024

   Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.

9. Cautious Optimism For Biotechs And Their Outsourcing Partners 9/5/2023

   Pre-revenue, including preclinical and clinical stage, biotechs have been the most impacted but also stand to gain the most after the economic downturn and subsequent recovery. This article will delve into how small to midsize pre-revenue biotechs have been specifically impacted and what this could mean for organizations that support them.

10. Three Trends To Know Before Selecting Your CDMO 2/15/2023

    Learn more about the desire for deeper collaboration between innovator companies and their CDMO partners, why companies are seeking robust drug development capabilities in-house, and why even global sponsors continue to seek partners based in the U.S.