Industry Insights

41. Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity? 10/12/2020

    Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.

42. U.S. Sites Play Surprise Role In FDA's Drug GMP Warning Letter Report 2/21/2020

    Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

43. Complex Parenteral Drug Manufacturing — A Foundation For Success 6/11/2020

    A first-hand account of what it takes to develop and manufacture complex parenteral drugs.

44. Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise 5/5/2021

    With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.

45. What The New ISO 21973 Guidance Means For Cell And Gene Therapy Developers 2/16/2022

    ISO 21973:2020 is a significant step forward in ensuring that therapies are transported consistently, with an emphasis on compliance, validation, decontamination, traceability, and quality management.

46. Overcome Complex Protein Challenges With Optimized Expression

    Realizing the potential of next-generation molecules calls on appropriate expression technologies and development processes that can facilitate their path to market.

47. Coronavirus Outbreak: Manufacturing, Supply Chain Lessons Learned 3/11/2020

    The COVID-19 outbreak serves important lessons on supply chain integrity. While events like this are impossible to completely prepare for, safeguards can reduce timelines and shorten supply impacts.

48. A Streamlined Approach To ¹⁴C Human ADME Studies 2/8/2023

    Understand the benefits of a program that allows for a flexible approach to human ADME studies and the breadth of supporting data and case studies that demonstrate both significant time and cost savings.

49. Gene Therapy Natural History Studies: Benefits, Timing, And Execution 6/28/2023

    Reap the benefits of natural history studies, such as the collection of contextual data, dry runs of expected clinical study visits, test deployments, and test endpoint sensitivity.

50. Viral Vector Commercialization – Part 2: Process Validation Lifecycle

    Learn how the validation lifecycle establishes a strong foundation for the successful translation of viral vector-based therapies from the laboratory to the clinic.