Industry Insights

31. Upskilling Your Quality Team For The AI Revolution In Pharma 4.0 3/21/2025

    While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.

32. The Digital Revolution: The Connected Lab Of The Future 10/12/2023

    The road to becoming a lab of the future can be challenging, with many obstacles along the way. Gain insight into the roles digital transformation and connectivity will play in the lab of the future.

33. Application Of A Novel Temperature Shift Process For Particle Engineering

    Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

34. Oncolytic Viruses Development And cGMP Manufacturing − Experience Matters

    Learn more about the leading oncolytic viruses, the leading cell lines, and how to strategize your oncolytic virus production plan.

35. How Digitalization Helps Manufacturers Overcome Operational Challenges 8/9/2024

    Discover how digitalization can offer better control and increased speed for cell and gene therapy manufacturers.

36. Revolutionizing Drug Discovery: The Rise Of Fashionable Models 6/6/2024

    As a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.

37. Do Chinese Hamster Ovarian (CHO) Cells Specimens Require An Import/Export License?

    On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) addressed an issue that has been of significant debate among importers of Chinese Hamster Ovary (CHO) cell specimens and trade experts. FWS informed the trade community that only shipments of actual CHO “cell”, “cell cultures” and “cell lines” are regulated by the agency and require an import/export license for trade. By Reynaldo Roman for Marken

38. How A Robust Manufacturing Software Solution Can Reduce The Frequency And Impact Of Deviations 3/22/2022

    Read how to leverage manufacturing software with robust digital tools to increase operational visibility and stay on top of deviations so that they don’t turn into corrective/preventive actions (CAPAs), or worse.

39. Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS 5/20/2020

    The biopharma industry uses the most sophisticated microbiological and genomic technology, and we experience waves of advancements in therapies driven by our computing and communications technology. So, why are we still drowning in 100-page paper batch records, books of SOPs on the plant floor, and paper documents being handled by operators?

40. How To Enable Your Quality Risk Management Lifecycle 11/29/2021

    The topics covered in this article represent some of the common risk management pain points and mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). This includes using consistent terminology, determining risk strategy, implementing QRM, and the advantages of early implementation.