Outsourced Pharma App Notes & Case Studies

  1. Novel Uses For Oral Solid Doses Driving Lifecycle Management Strategies

    With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.

  2. Quality By Design: A Holistic Approach To Drug Development

    While QbD evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?

  3. The Criticality Of API CDMO Selection: Insights From A Client

    4SC AG, a clinical-stage biopharmaceutical company partnered with Thermo Fisher Scientific Pharma Services, whose experienced team helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, leading to a path toward commercial success.

  4. Strategies For API Solubility And Bioavailability Enhancement: Selecting Technologies And Excipients

    Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of formulations, and increase overall speed to market.

  5. Improved Bioavailability Of Trio Medicines In 12 Weeks

    Learn how a structured 3-step approach can help overcome the challenge of molecular characterization and a limited budget.

  6. Capacity And Performance Of MabSelect™ PrismA Protein A Chromatography Resin

    This application note demonstrates the binding capacity of MabSelect PrismA in comparison with its predecessor products for both polyclonal and monoclonal antibodies.

  7. Multidimensional Scale-Up Of A mAb Capture Step Contributes To Shortened Time To Market

    This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.

  8. Model Extraction Studies Examined For Monoclonal Antibody In Prefilled Syringe

    It’s been more than 30 years since monoclonal antibodies (mAbs) were first licensed for clinical use. But product developers are still inventing novel ways to improve their safety and efficacy.

  9. Process-Economy Simulation Of mAb Capture Step With Protein A Chromatography Resin

    Calculation examples that highlight scenarios where the enhanced capacity and alkaline‑stability of MabSelect PrismA can provide process economic benefits to large‑scale mAb processing.

  10. Complex Molecule Development: Early Considerations To Avoid Failing Later

    How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time to market.