Drug Discovery App CS WP

51. Route Development: Designing Synthesis For GMP Production 1/24/2022

    The successful transition from initial synthesis of an API to a kilogram-scale route requires expert analysis and design, and a balance of economic, regulatory, and time constraints.

52. Rapid Characterization Of Impurities 1/24/2022

    Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.

53. Qualified Reference Standards: Setting The Standard For Product Quality 1/24/2022

    Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity.

54. Peptide Synthesis: Delivering Cost-Effective Strategies 1/24/2022

    For peptide APIs, using a liquid phase peptide synthesis (LPPS) approach offers a cost-effective process for large-scale manufacture by eliminating the need for specialized equipment and excess raw materials.

55. Crystallization Process Development: Peptide Crystallization 1/24/2022

    Whether performed during formation of an API or as a means to purify intermediates, achieving control of nucleation and crystal growth is critical to designing a successful peptide crystallization process.

56. Overcoming Limitations To Achieve Uniform Dosing 1/24/2022

    An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

57. Selective Crystallization Of A Novel Polymorph 1/24/2022

    Discover how applied rigorous characterization standards and expert knowledge of critical water activity enabled the isolation of a previously undiscovered and uncharacterized polymorph.

58. Mitigating Hidden Risks: Extractables And Leachables 1/24/2022

    Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

59. Method Optimization: Assay Development Following Compendial Methods 1/20/2022

    There was a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.

60. Method Development: Managing A Diverse Range Of APIs 1/20/2022

    See how the team developed analytical methods to support pre-clinical and future GMP production under tight timelines.