Industry Insights

51. Best Practices For Gene Therapy BLA/MAA Submissions 7/1/2025

    Medical writers completing gene therapy submissions require strategic placement, justification, and cross-referencing to fit unconventional data within a standard template.

52. Cell & Gene Therapy Supply Chain: Early Preparation Is Key 5/19/2022

    The complexity of CGT development and manufacturing is unique compared to small molecule production. Supply chain management for CGTs requires precise demand planning and forecasting.

53. Why Should We Rescue The Legislative Intent Of The BPCIA? 7/28/2021

    What happens when regulatory ambiguity displaces sound scientific guidance, deterring the legislative intent of Congress? This is precisely the situation regarding the FDA changing the regulatory rules of the road regarding a biosimilar’s strength versus its potency.

54. 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.

55. Artful Taste Masking Improves Patient Compliance 5/12/2022

    Taste masking is required for dosage forms that interact with the taste buds. Discover some of the best and most practical taste masking methods to consider for each API.

56. Understanding The Hidden Value Of Quality 6/26/2023

    Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.

57. rAAV Bioreactor Titer Of >1E15 vg/L With Plasmid Transient Transfection 10/12/2022

    When pursuing transient transfection, there are three key factors that can serve to inhibit a process: poor packaging, low productivity, and an inability to scale up.

58. Exploring Sanofi R&D's Batch Monitoring Initiative 10/23/2024

    The project established predictability during testing and release for the production of medicine to support clinical trials.

59. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

    AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

60. Developing Novel Policy Proposals To Support Access To Gene And Cell Therapies 10/4/2019

    The decades-long focus on more “personalized” medicines has paved the way for the recent and anticipated advances in gene and cell therapies and progress in many other areas. The first generation of gene and cell therapies has the potential to transform the way we treat some diseases and can bring new hope to patients with many rare and serious conditions.