Articles, App Notes, Case Studies, & White Papers

  1. Navigating Regulatory Challenges In Oligonucleotide Therapeutics 12/12/2024

    Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.

  2. Developing And Manufacturing Drugs With HPAPIs 1/27/2025

    Learn why companies must invest in specialized expertise to develop scalable, safe, and efficient manufacturing processes for highly potent oral solid dose products.

  3. Platform Reduces Product Development Time And Cost By 30% 3/4/2022

    Using innovative capsule-filling equipment and processing technology, and mini-tablet and drug-layered beadlet manufacturing, you can have an adaptable, easily modified formulation.

  4. Annex 1 – The Brave New World Of Regulatory Compliance 2/3/2023

    The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.

  5. Application Of A Novel Temperature Shift Process For Particle Engineering

    Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

  6. Reducing Environmental Impact At All Stages Of The Medicine Journey

    Explore how utilizing technologies like AI and digital twinning can inform decision-making at the R&D stage and how to optimize the delivery of the final drug product to patients with greener logistics.

  7. Formulation Development Strategy For Early Phase Human Studies 1/27/2022

    Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.

  8. Solving The Silicone Challenge In Pre-Fillable Syringes 8/27/2024

    Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

  9. Leveraging Advanced Mass Spectrometry To Fulfill IND, IMPD And BLA Filings

    Because mass spectrometry (MS) can characterize an array of product quality attributes, the technique is invaluable across the lifecycle of a biopharmaceutical product.

  10. Microbial Expression System For Efficient Production Of Therapeutic Proteins

    The combination of unique and proven plasmids, fast process development, and automated downstream analysis ensures rapid progression from gene to optimized, high-titer fermentation process.