Liquid Dose White Papers & Case Studies

1. Microbial Challenge In-Use Studies 6/13/2024

   Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

2. Accelerating SARS-CoV-2 Immunotherapy Speed To Clinic 4/26/2024

   A clinical-stage biotherapeutics company developing a COVID-19 immunotherapy searched for a solution to the difficulties it faced in scaling up its manufacturing operations due to limited resources.

3. Extractables And Leachables Testing 4/9/2024

   Learn how to navigate the extractables and leachables regulatory landscape and implement best practices for leachables analysis in your pharmaceutical development process.

4. Manufacturing Challenges With High Concentration Biologics 3/18/2024

   Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

5. Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence? 9/5/2023

   Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

6. Electron Activated Dissociation Workflow For Biotherapeutics Characterization 8/28/2023

   Explore the benefits of an electron-activated dissociation middle-down workflow, including the ability to achieve high sequence coverages (70%-80%) of monoclonal antibody subunits in a single injection.

7. Switching From Vials To PFS And Intravenous To Subcutaneous Formulations 7/25/2023

   Learn about formulation development challenges for prefilled syringes as well as considerations for reducing the time it takes to launch safer, more convenient, and cost-effective products for the patient.

8. Nasal Vaccine Development, Manufacturing, And Device Selection 7/11/2023

   When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.

9. Successful Planning: Process Liquid & Buffer Preparation 6/23/2023

   Obtain an accurate total cost of ownership assessment through understanding common operational inefficiencies, risks, and financial burdens associated with process liquid and buffer preparation.

10. How Successful Tech Transfer Can Help Fast-Track NDA Approval 4/4/2023

    Examine the first-time-right tech transfer and phase-3 registration batch manufacturing process which led to a biotech receiving NDA approval for its novel compound followed by a successful commercial manufacturing partnership.