ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS

  Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.

• Solutions For Challenging Compounds Using Softgel Innovation

  The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems. 

• Avoiding The Pitfalls Of LNPs And Complex Formulations

  Explore the necessary components of a smooth tech transfer for LNP-based drugs, including the variables that impact LNP formulation and the outsourcing strategies needed to avoid common pitfalls.

• Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway

  Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

• Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems

  Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.

• Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing

  This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

• Your Approach To USP <382> For Your Drug Product Packaging

  The USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge container closure systems.

• Why It Is Never Too Early To Consider Tungsten Interactions

  A key challenge to sensitive biotechnological or biologic drugs, especially proteins, is the potential presence of tungsten and tungsten oxides from the syringe forming process.

• Key Considerations For Selecting Fill/Finish Manufacturing Technologies

  Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.

• Masking Bitter Drug Taste In Pediatric Formulations With Microcaps

  The challenge was developing a taste masked, convenient dosage formulation of a very bitter API for patients two-years old and older undergoing treatment of HIV infection.