ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Key Offerings To Support Your OSD On Its Journey To Market

  Examine several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.

• Solving For The Future Of Drug Delivery

  Next-gen therapeutics require equally advanced delivery systems—localized, personalized, and precise—to ensure efficacy, safety, and scalability. Delivery is now a central driver of innovation.

• Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations

  Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.

• Stability Chambers: Testing, Equipment, And Uses

  Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.

• PHI And Medical Devices: What Device Manufacturers Need To Know

  Connected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.

• Streamline Microbial Process Development To Reach Toxicology Trials Faster

  For biopharmas looking to outsource their early phase development, consider working with a CDMO partner that has the knowledge and experience to navigate microbial fermentation and complex process development.

• A Risk-Based Approach To Injectable Combination Product Development

  Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

• Developmental Testing Of IV Solutions

  As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.

• Start Packaging Development Early: De-Risk Before You Build

  When packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.

• The Largest LOE Event In US Pharma History

  Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.