Outsourced Pharma White Papers

1. Accelerated API Manufacturing: Combining All Process Development Stages 3/17/2026

   During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.

2. Quality By Design (QbD) For Biologics From A CDMO Perspective 2/18/2025

   Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

3. Antibody-Based Drug Discovery At The Speed Of Light 5/23/2025

   Review this end-to-end workflow, including First-to-Human antibody development strategies, the use of the PentaMice® platform for targeted immunization, and the precision of single B cell screening.

4. 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.

5. Designing A Disinfectant Study For Your Cleanroom 5/14/2024

   Disinfectant efficacy studies are crucial for safeguarding the sterility of your manufacturing facilities. Gain expert insights into the intricacies of these important studies and how to design one.

6. Guiding Principles For Process Development And IND Readiness 7/25/2025

   Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.

7. Operational Success By Strategic Investment 1/22/2026

   Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

8. The Benefits Of Incorporating Lean Methodologies Into Project Management 8/20/2024

   Delve into the core principles of lean project management and explore how these principles can be integrated with traditional methods to enhance project outcomes.

9. Tablet Manufacturing Technologies For Solid Drug Formulation 4/2/2025

   Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.

10. Improvements In ADC Efficacy And Stability 3/17/2026

    Antibody-drug conjugates combine targeted antibodies with potent cytotoxic payloads, but increasing hydrophobicity challenges stability, manufacturability, and pharmacokinetics, driving interest in hydrophilic linker strategies to improve performance.