Guest Columns

1. Single-Use Bioreactors Gain Popularity Worldwide 9/29/2023

   Industry momentum is trending in favor of single-use bioreactors as a plurality of biopharma companies are opting for the disposable version of bioreactors, according to new market research. Let's look at the drivers of this change, regional analysis, and prominent vendors in the space.

2. Preformulation Of Excipients In Biologics Development 9/28/2023

   Most of the instability problems of a drug product come from excipients, in particular, they come from impurities in excipients. Those issues are best cleaned up in the preformulation period to determine excipient compatability.

3. Global Market Trends For Oligonucleotide APIs 9/28/2023

   Oligonucleotide APIs belong to a category of compounds that comprise short sequences of DNA or RNA. These compounds can be tailor-made to target an individual gene’s messenger RNAs. This article shares new market research, including a look at the drivers behind growing demand, different types of oligonucleotide APIs, and key players in the space.

4. Why Royalty Financing Is A Smart Funding Alternative For Small Life Science Companies 9/27/2023

   Royalty financing has emerged as an attractive solution to secure funding in the current challenging fundraising environment, offering a range of advantages tailored to the unique characteristics of small life science companies, from preserving ownership and intellectual property control to providing accessible funding for high-risk ventures.

5. FDA Gives More Time To Comply With Certain DSCSA Requirements 9/27/2023

   To the relief of pharmaceutical companies and their trading partners, the FDA has paused enforcement of some Drug Supply Chain Security Act requirements. The agency warns that it's not an excuse to delay compliance.

6. FDA Introduces Quality Management Maturity Program 9/26/2023

   The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.

7. How To Lose A Batch In 10 Days 9/25/2023

   Inspired by the rom com How to Lose a Guy in 10 Days, this article spotlights the critical missteps that could lead you to lose a batch during the manufacturing process. By identifying these pitfalls, the author guides you toward best practices that will not only save your batches but also improve the quality, efficiency, and reliability of your operations. 

8. Understanding The FDA’s Current Focus On Risk Evaluation And Mitigation Strategies 9/21/2023

   The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.

9. Allogeneic Cell Therapy: Our Strategy, Learnings, & Advice 9/20/2023

   Celularity is a Florham Park, NJ-based biotech company developing off-the-shelf placental-derived allogeneic cell therapies. We caught up with Robert Hariri, CEO, founder, and chairperson of Celularity, to discuss the company’s facility site selection strategy and scale-up plans, lessons learned during early development, and more.

10. Essential Elements Of Technology Transfer 9/19/2023

    The principles of an effective technology transfer can apply at every stage of the drug development lifecycle for biotech companies of every size. Tech transfer programs are usually bespoke, but they share common essential elements. This article breaks them down.