Industry Insights

51. Resistance Or Defiance? The FDA And The 11th Circuit Spar Over Statute On Orphan Drug Statutory Exclusivity 2/23/2023

    Last September, the 11th Circuit Court of Appeals sided with a challenge to the FDA’s long-standing interpretation of the Orphan Drug Act by broadening the scope of orphan drug exclusivity under step one of the Chevron legal analysis. But the FDA has pushed back.

52. Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing 6/12/2023

    Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.

53. 6 Emerging Trends In Pharmaceutical Tablet Coatings 6/26/2023

    Tablet coatings have evolved to play a pivotal role in improving the overall appearance, functionality, and stability of tablets. Here are six emerging trends and a look at the overall tablet coatings space.

54. Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides? 12/10/2024

    Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.

55. Containment Liability: Choosing Assurance Or Insurance

    Engineering controls designed to mitigate exposure and create separation between the operator and toxic material are available in many forms, all with their own unique advantages and risks.

56. Liquid Capsule Manufacturing: What To Know 5/4/2022

    Capsules surround a drug in an unflavored, solid barrier enclosure. This article focuses on liquid capsule manufacturing and its advantages.

57. Why We Shouldn't Be Categorizing Digital Therapeutics As Drugs 8/2/2021

    Payers and health plans handle digital therapeutics inconsistently. They sometimes treat them as medications. The manufacturer would have a role in this determination. This article delves into what digital therapeutics are and are not, and why the industry should not be categorizing them as drugs.

58. You May Be Sabotaging Your Pipette Cleaning Process 12/9/2016

    Despite good intentions, you could unknowingly be opening the door to a whole new arena for inaccuracies. That’s because glass pipettes, by nature skinny and fragile, are difficult to clean.

59. Modularity And Mobility Hold The Keys To Surge Manufacturing 11/30/2022

    When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.

60. Data Management: 5 Best Practices For Emerging Biotechs 2/14/2022

    Whether your ambitious upcoming pharma startup or biotech has its sights set on being the world’s first in your field, or a lucrative exit through a strategic company sale, starting out with good data management practices will set you up for success for the future you envision.