Application Notes & Case Studies

1. Choose The Right Cleanroom Insulation To Cut Hazardous Particulate Emission 1/21/2022

   In this application note we consider the issues and describes a test protocol developed to measure the particulate contribution of three different types of insulation during typical cutting and fitting operations within a cleanroom.

2. Detecting And Analyzing Cytokines The Simple Plex Way 1/21/2022

   Cytokine detection, measurement and monitoring important to clinicians and researchers alike. We’ll show you how scientists are already using technology to do everything an ELISA does, but faster. Oh, and with greater sensitivity and reproducibility.

3. Method Development: Managing A Diverse Range Of APIs 1/20/2022
4. GMP Manufacturing: Delivering Quality On An Accelerated Schedule 1/20/2022

   Coordinating the sourcing, setup and technology transfer of API and drug product to supply clinical sites with manufactured product is a complex series involving multiple processes and stakeholders.

5. Full IND Program: Exceeding Requirements For Submission 1/20/2022

   Follow a compound through a full cycle of IND development, from modifications to the synthetic route to formulation development and API manufacturing.

6. Crystallization Process Development: Ramping Up Bench-Scale Control For Manufacturing 1/20/2022

   Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

7. "Ultra High” Potency Development And Manufacture 1/20/2022

   A biotechnology company with limited experience in the development and manufacture of high potency compounds sought to develop a process for producing a highly potent API used to treat an unmet oncology need.

8. Speed To Market – API Large Scale Commercial Manufacturing 1/20/2022

   A pharmaceutical company was looking to partner with a CMO with commercial manufacturing capabilities, large scale assets, multinational sites and exemplary quality systems/US FDA track record.

9. Adapting To Change - API Custom Development And Manufacturing 1/20/2022

   A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase II / III trials.

10. Investing In Capacity – API Commercial Manufacturing 1/20/2022

    A pharmaceutical company sought a CMO partner with commercial manufacturing capabilities and expertise and exemplary quality systems to find a cost-effective process to produce the API for a new drug.