Insights On CONTRACT PHARMA MANUFACTURING

31. How Strategic CMC Planning Drives Cell Therapy Success 10/7/2025

    CMC is essential for cell therapy success, with FDA CRLs often due to CMC gaps; early strategic planning and robust controls reduce risks and accelerate market approvals.

32. Regulatory Bar Raised For Cell Therapies: Are You Ready? 10/7/2025

    Since 2024, multiple cell and gene therapy programs faced regulatory delays due to manufacturing deficiencies, highlighting the critical need for robust CMC strategies and inspection-ready operations.

33. Quality Foundation: Aligning Operations And Quality For Patients 10/7/2025

    Quality is the foundation of leadership and operations, ensuring collaboration and strategic focus to deliver safe, effective cell therapies without compromising patient safety or regulatory standards.

34. Mitigating Powder Flow And Static Issues Using SYLOID® Mesoporous Silica 10/7/2025

    See how incorporating small amounts of mesoporous silica during micronization can significantly enhance powder flow, thereby making subsequent blending and formulation more efficient and consistent.

35. SYLOID® Silica For Enhanced Micronization Efficiency 10/7/2025

    Here, we demonstrate how adding small amounts of SYLOID® mesoporous silica to Cholesterol before jet milling can enhance processing efficiency, boost yield, and improve micronization performance.

36. Enhancing Micronization Processes With Mesoporous Silica 10/7/2025

    Discover how using mesoporous silica as a means to enhance the micronization process is redefining the path to more efficient and reliable API formulation.

37. Sniffing Out Solutions In The Nasal Drug Delivery Revolution 10/7/2025

    As research continues to advance, nasal drug delivery stands at the intersection of innovation and practicality — offering a unique opportunity to expand therapeutic reach while rethinking how medicines are administered and experienced.

38. TARGATT™ Rapid And Efficient Transgene Integration Technology: Stable Cell Line Development And Generation Of Large Mammalian Cell-Based Screening Libraries 10/3/2025

    TARGATT™ technology enables precise, efficient single-copy gene integration into safe harbor loci for stable cell line generation and large-scale mammalian cell library screening.

39. Advancing Therapeutic Development With iPSC, Genome Editing Tech 10/3/2025

    Genome editing and iPSC technologies can speed up preclinical model creation, assay development, safety testing, and CMC consultation to streamline screenings and IND filing.

40. How-To Guide For TARGATT™ Transgenic Kit 10/3/2025

    The TARGATT™ Kit enables fast, precise site-specific transgenic mice generation, avoiding random insertion issues and ensuring stable gene expression within three months.