Guest Columns

31. Opportunities For AI To Assist Cell & Gene Therapy Companies 10/10/2023

    Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways.

32. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1 10/6/2023

    All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a 3-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.

33. Is ‘Human Error’ The Cause Or The Outcome Of GMP Deviations? 10/6/2023

    Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.

34. Here’s Why Outsourcing To CDMOs Doubled In 13 Years 10/4/2023

    It might surprise no one that BioPlan Associates' 20th annual survey on manufacturing found an increased dependence on contract manufacturing. The sheer rate at which demand has grown, however, is stunning, and the survey found CDMO capacity is only now starting to catch up with supply.

35. FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don’t Mistake It For An Enforcement Delay 10/4/2023

    On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.

36. 7 Improvements in Clinical Supply Chain Management Your CFO Will Love 10/2/2023

    There is a great opportunity for clinical supply chain practitioners to learn from their commercial peers. By adapting and adopting the right commercial best practices, clinical supply chains become more effective, cost-efficient, and agile in delivering the right treatments to the right patients.

37. 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.

38. 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.

39. 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.

40. 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.