ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• The Impact Of PFAS Regulations On Drug Delivery Devices

  By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.

• Data-Driven Approach Optimizes Robust, Scalable Lyophilization Process

  Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and analytical capabilities can speed drug development and expedite time to market for lyophilized drugs.

• Trends In Combination Products

  As demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.

• The Dynamic Regulatory Environment Of Drug-Device Combination Products

  Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.

• Design And Packaging Advantages For Cell And Gene Therapy Drugs

  With the increasing demand for cell and gene therapies, Crystal Zenith nested vials can help the biopharma industry overcome the challenges of scaling up manufacturing and logistics.

• A Robust Extractables Data Package Helps Drive Patient Safety

  Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

• 3 Keys To Rare Disease Clinical, Commercial Drug Product Manufacturing

  The complex biology of rare diseases creates unique hurdles, making it difficult to design and implement a drug development program. Explore the unique considerations for drug product manufacturing.

• Patient Adherence With A Novel Dosage Form

  A sprinkle formulation helps patients with tremors or dysphagia take medication more easily, improving adherence, comfort, and care through a novel, FDA-approved oral granule format.

• Partnering With Clinicians To Improve Pediatric Formulation Development

  Greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.

• Recent Innovations And Enhancements To Pharmaceutical Spray Drying

  Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.