Outsourced Pharma App Notes & Case Studies

1. A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation 1/15/2025

   Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.

2. Lyophilization To Enable Drug Products Containing Labile Molecules 6/6/2025

   Develop lyophilized formulations to overcome stability challenges and significantly extend the shelf life of sensitive therapeutic products.

3. Integrated Services For Cell Line Preparation And Storage 10/8/2024

   Explore a comprehensive suite of services for the manufacture, characterization, and storage of cell banks as well as the advantages of working with an experienced partner.

4. Formulation Development For Therapeutic Oligonucleotides 6/10/2025

   Discover how expert formulation and analytical support enable the development of stable, injectable oligonucleotide therapies across diverse delivery routes and molecule types.

5. GMP Manufacturing Cycle Time Reduction 11/24/2025

   Identifying process redundancies and enhancing visual management allows manufacturers to stabilize workflows. These data-driven improvements can decrease operational variability by nearly 50%.

6. Partnering With Health Systems: Essential Tips For CGT Commercialization 12/5/2025

   Successful cell and gene therapy commercialization requires early, detailed manufacturer collaboration with health systems to ensure scalable operations and seamless patient access beyond the clinical trial.

7. Get Full Control Of Your T Cell Isolation 3/25/2024

   This study demonstrates the automated magnetic isolation of CD4/CD8+ cells from fresh or frozen leukapheresis using a functionally closed cell processing system paired with a modular application.

8. Analytical Method Saves Dual-API Injectable Project From Stalling 12/2/2025

   Developing a stability-indicating analytical method for a dual-API injectable product requires careful forced degradation studies. Review the robust testing approach that ensured project progression.

9. Form Fill And Seal Label Applicator For Drug Packaging 12/16/2024

   Discover a solution that ensures particularly efficient and reliable vertical and horizontal form fill and seal machine labeling.

10. Achieving Faster Timelines And Cost Savings Through Digital Validation 2/11/2025

    Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.