Insights On Drug Development

  1. Current And New Technologies To Characterize Advanced Therapies: Making The Right Decisions Upstream To Ensure Downstream Success 5/12/2022

    Explore the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.

  2. 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.

  3. Oral Solutions & Suspensions: The Art Of Pharmacy 5/12/2022

    Despite advantages, there are challenges associated with liquid dosage, such as stability and palatability, parameters that need to be considered in the design.

  4. Considerations To Get Your CAR T Testing Strategy Right 5/10/2022

    Review three considerations to prepare for as part of analytical development prior to finalization of CAR T related FDA guidance.

  5. Improving Recovery And Quantitation Of Oligonucleotide Impurities Using MaxPeak HPS Technology 5/5/2022

    Evaluate the ACQUITY Premier Solution compared to conventional stainless-steel columns and LC systems having a metal-containing flow path for UV-based analysis of oligonucleotides to address the challenges associated with non-specific adsorption.

  6. Automated Data Processing For Mass Confirmation And Impurities Analysis Of Oligonucleotides 5/5/2022

    We demonstrate an automated, compliance-ready LC-MS worflow for intact mass confirmation and purity analysis of synthetic oligonucleotides including small interfering RNA (siRNA) and large single guide RNA oligonucleotides and their impurities.

  7. Selecting An Appropriate Ion-pairing Agent For Impurity Analysis Of Oligonucleotides 5/4/2022

    Learn about method development considerations when selecting an appropriate ion-pairing agent and impurity analysis of dye-conjugated oligonucleotides.

  8. Embracing LC-MS Analytical Techniques Into Regulated Laboratories 5/4/2022

    We address the additional compliance challenge in biopharma of the requirement of complex analytical instruments that are not traditionally used in highly regulated labs.

  9. Process Platforms Vs. Custom Process Development For AAVs And Gene Therapies 5/4/2022

    To address cost, time to market, and manufacturing complexity, many developers have turned to turnkey manufacturing platforms. Can these platforms provide the right solution for successful CMC development?

  10. Direct LC-MS Characterization Of Glycoform Distribution And Low Molecular Weight Impurities In mAb Process From Ambr® 15 Bioreactors 5/4/2022

    We demonstrate a streamlined and robust mAb product monitoring method that is high throughput capable and has the potential to be a fully automated platform for mid-process intraday monitoring of CQAs.