WHITE PAPERS AND CASE STUDIES

• Mobile Lab For A Large Pharma Client

  Completed in 2021, learn how this custom BSL-3 mobile laboratory received PHAC approval and ensured a secure environment for PPD powder-related MTech development work.

• Project Orbis Drug Registration 2025

  Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

• The Effect Of Conventional Cooling Versus Controlled Ice Nucleation On Primary Drying Time

  See how controlled ice nucleation shortens lyophilization cycles, supports higher drying temperatures, and reduces complexity for amorphous and mixed formulations without sacrificing quality.

• NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission

  A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

• How To Avoid Sticking And Picking In The Tableting Industry

  Review strategies to mitigate sticking and picking risks in the tablet industry, and learn how you can foster improved tablet production processes, ensuring higher quality and consistency.

• PEG In LNP Formulations: Addressing Challenges And Seeking Solutions

  Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks.

• Development Of A Non-Standard Protein Therapeutic

  Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.

• Early-Stage Development In Rare Pediatric Oncology

  Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.

• Accelerating SARS-CoV-2 Immunotherapy Speed To Clinic

  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.

• What Re-Acquisition In Retinal Imaging Is Really Costing Your Program

  High screen failure rates and patient dropout often stem from preventable imaging errors. Learn how proactive quality control and patient-centric logistics secure critical retinal trial data.

• A Digital Solution Embeds Quality Into Cellular Therapeutics Production

  Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.

• Quantitation Of Monoclonal Antibodies In Serum

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