Outsourced Pharma White Papers

1. AAV-Based Gene Editing For Huntington's Disease 10/28/2025

   LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

2. SMB Technology: Optimizing API Purification 6/13/2025

   Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.

3. Human Skin Explant Model For The Investigation Of Topical Therapeutics 8/4/2025

   Learn more about an ex vivo cultured human skin explant model in which pathological tissue integrity, barrier function, and metabolic stability have been characterized over time.

4. Quantitation Of Monoclonal Antibodies In Serum 2/8/2024

   Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.

5. Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process 2/8/2024

   Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.

6. Process Development For Lyophilized Products 10/16/2024

   Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

7. Challenges And Solutions In Lyophilization Development For ADCs 12/10/2025

   Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

8. Super Short Activated CAR-T Process 1/17/2025

   Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

9. FDA's Regenerative Medicine Advanced Therapy (RMAT) Program 12/10/2025

   RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

10. 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.