Industry Insights

41. Turnover Packages (TOPS) For Industrial Construction Projects 12/20/2023

    If you think a construction turnover package (TOP) plan in industrial projects is optional or just a recommendation, think again. Learn how to manage and execute TOPs to achieve operational readiness.

42. Industry 4.0 In Biomanufacturing – Implications And Opportunities 6/16/2022

    Read how single-use technologies are making supply chains more efficient and reduce product loss by providing specific protective technologies, equipped with Pharma 4.0 mechanisms.

43. What You Should Expect From A High-Functioning CDMO 5/18/2023

    In part one of a two-part series, the authors detail whether to make or buy and how to work effectively with a CDMO.

44. 6 Reasons To Transition To A Cloud-Based Lab Data Management System 7/3/2024

    Dig deep into some of the compelling reasons to move from on-premise to a cloud-based laboratory data management system.

45. Strategizing The Scale-Up Of Cell Therapy Manufacturing Capacity 4/19/2023

    Adaptimmune’s Mike Blankenstein, vice president of patient supply operations, discusses the team's manufacturing network strategy designed to evolve with them as the company grows from clinical to commercial supply needs, balancing cost and risk, while ensuring flexibility to respond to patients’ needs.

46. Consumables Are Leading The Cleanroom Market — Here's Why 2/19/2025

    As the industry expands, so, too does demand for PPE. This market analysis looks at the trends in consumables and other cleanroom technology used to make medicine.

47. Bad Quality Is Contagious: Stop Before It Spreads 1/25/2013

    Disregarding the rules in the regulated industry is like a contagious disease. If you don’t control it in the beginning, you and your organization will be lost. In advanced stages, it could require the termination of many employees with this disease.  When the FDA recommends you hire fresh eyes for quality systems on a warning letter, it actually means your problem is institutionalized. That’s why I recommend a biannual general audit by a third party. Even if you think you can go more than two years without an audit, this bad behavior can grow roots and can infect the quality culture of your organization. Then, when you do receive a visit from the FDA, it will be easier to correct unwanted behaviors and to renew your quality system, if needed. By Rosario Quintero-Vives, Sr. Regulatory & Compliance Specialist, RQV Consulting

48. Unlocking Potential: A Deep Dive Into AAV Development And Manufacturing 7/9/2024

    When it comes to furthering AAV's potential in the wider biopharmaceutical pipeline, partnering with a CDMO that can foment an optimal analytical and manufacturing strategy is crucial.

49. Delivering Genetic Editing Therapies To Market

    Manufacturers with proven expertise in areas like viral vector production and analytics are needed now more than ever to get breakthrough, deliverable gene editing therapies to patients.

50. Develop And Industrialize Novel Bacterial Strains At New Brisbane Facility 7/8/2024

    While the Brisbane facility’s key value is facilitating development and industrialization of new bacterial strains, how this is accomplished separates it from would-be competitors.