ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Design Success Combined With Expertise In Testing And Raw Material Selection

  Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.

• Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

  As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

• Sophisticated Formulation Approaches For Insoluble Drug Candidates

  A sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.

• Safeguarding Biologic Integrity Through Enhanced Component Compatibility

  For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.

• Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?

  Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.

• Contract Design And Development Vs. In-House: How To Find The Best Fit

  Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.

• Plan For Your Extractables And Leachables Studies To Meet Submission Timelines

  Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.

• 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.

• USP <382>: Think Systems, Not Components

  This blog focuses on the application of USP <382> prescribed testing to cartridges and syringes from a mechanical testing perspective.

• The Algorithm Is In: 5 Ways AI Is Transforming Medicine

  AI is transforming the medical field, offering innovative solutions to complex problems. Explore the potential of AI in revolutionizing healthcare and leveraging data to improve patient experiences.