ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Enabling Subcutaneous Delivery For Improved Patient Compliance

  The ability to administer high doses of biologics subcutaneously offers numerous benefits, including reduced treatment burden, improved patient convenience, and increased adherence to treatment regimens.

• 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.

• Choosing A Formulation And Process Approach To OCR Products

  Do you want to develop an oral controlled release (OCR) product? Understand the options and their ramifications as the first step toward devising a plan.

• 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.

• Annex 1 – The Brave New World Of Regulatory Compliance

  The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.

• Why Connect An Auto-Injector To A Smartphone?

  Why would a person with diabetes want to link their auto-injector to the Internet? Given that smartphones are so central to our everyday lives, it could be argued that the better question is: Why not? 

• Impact Of Post-Covid Literacy Decline On Medical Device Studies In Youth

  Examine the challenges of using traditional human factors methodology with young individuals whose literacy levels have declined compared to historical data.

• Selective Crystallization Of A Novel Polymorph

  Discover how applied rigorous characterization standards and expert knowledge of critical water activity enabled the isolation of a previously undiscovered and uncharacterized polymorph.

• Parenteral Packaging And Delivery Systems: Container Closure Integrity

  Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.

• Nanosuspension Dosage Forms: Product Development & Scale Up

  For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.