ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Solid Form Strategies For Increasing Oral Bioavailability

  Optimizing a drug’s solid form can improve its solubility and bioavailability when further molecular modifications are prohibitive.

• Sterile Injectable Therapies: Revolutionizing Lifecycle Management

  The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.

• Best Practices For Ensuring Quality In Biologic Products

  New biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes. 

• Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway

  Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

• How Subcutaneous Delivery Can Help Patients Manage Chronic Conditions

  Read more about how to improve your patients’ outcomes, avoid costly delays to launch, and provide a better return on investment.

• CMO As Partners For ADC Process Development, Scale-Up, Optimization

  ADC programs can accelerate through clinical phases rapidly, making early preparation for commercial launch imperative. It's sensible to partner with a CMO with a strong biologics foundation.

• Leveraging Integration At Each Phase Of A Drug Delivery System Project

  By forging deeper partnerships with customers, the full depth and breadth of our knowledge, experience and competencies can bring benefits at multiple levels. See how an integrated offering helps at each phase of a drug delivery system project.

• Fixtures And Surrogates For Combination Product Performance Testing

  The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based combination products presents several challenges that require careful consideration.

• The Importance Of A Human Centered Approach To Product Development

  To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.

• FAQs On The Revised EU GMP Annex 1: Volume 1

  The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.