Industry Insights

1. Key Considerations In Early-Stage Biopharma Financing 5/11/2022

   After over two years of soaring IPO valuations and high stock prices, biotech had a reckoning in the back half of 2021. But while the industry is clearly facing headwinds, there’s significant cause for optimism for early-stage biotechs looking for funding, not the least of which is 2021’s high levels of venture capital fund formation.

2. Ensuring Drug Accountability In Clinical Trials 10/1/2021

   Pharmaceutical companies and regulators can’t be assured the results of the trial are accurate if there’s information missing from the drug accountability record. Ensuring proper drug accountability is far from simple. It requires forethought and consistency to be done properly.

3. Can CHO Bioreactors Be Used For Plant-Based Protein Production? 9/22/2025

   The moss Physcomitrium patens is especially good at producing glycoproteins. Established technology and prior knowledge are helping one company develop new therapies with it.

4. Is Your QMS 21 CFR Part 11 Compliant? 12/5/2022

   With many options for digital transformation in the quality software sector, there’s never been more opportunity to digitize your QMS. Explore the benefits of a digital QMS and more.

5. Fine-tuning Analytical Development Strategies For Every Phase 3/22/2024

   Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

6. The Future Of CGT: Phase-Appropriate Plasmid DNA Manufacturing 10/16/2025

   Effective CGT development hinges on phase-appropriate manufacturing. Matching manufacturing rigor to the clinical phase ensures the right quality at the right time while reducing costs and accelerating timelines.

7. 5 Steps To Pass Your ISO 9001 Audit 5/18/2023

   Reduce your pre-audit stress and pave the way to successfully meeting ISO 9001 standards and becoming certified.

8. How The Tariffs Could Impact Your Drug Development Supply Chain 4/16/2025

   Explore how a fully integrated, U.S.-based supply chain strategy can help you navigate potential tariff risks, reduce complexity, and strengthen resilience in pharmaceutical development.

9. 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations 9/22/2021

   The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.

10. Developing A Smart Inhaler For Optimal Drug Delivery 12/16/2019

    While the development and design of inhalers has improved significantly over the last decades, the use of inhaled therapies for treatment of systemic diseases has been limited by a number of factors.