ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• USP Draft Chapters On CCS: What You Need To Know

  Learn why it's important to stay aligned with evolving Annex 1 expectations to support sterility assurance, regulatory compliance, and patient safety across sterile drug manufacturing operations.

• Considerations In Development & Manufacturing Of Complex Injectables For Early Phase Studies

  A niche CDMO, with specialized technologies in complex injectable development, will have greater flexibility for successful manufacture of complex injectables in early phase development of therapeutic drugs.

• How To Find The Right Balance In Cell Therapy Manufacturing

  The choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.

• Aseptic Filling And Processing Considerations For Biosimilars

  One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.

• Delivering On GLP-1 Demand: Combining Device And Supply Strategy

  Meeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.

• 3D Screen Printing: Enabling A New Generation Of Complex Formulations

  Screen-Printed Innovative Drug Technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.

• Navigating PFAS "Forever Chemicals" In Medical Devices - What's On The Horizon

  Gain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry.

• Is It Ever Too Soon To Start Your Performance Testing Assessment?

  Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

• Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing

  Lonza’s SimpliFiH^®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.

• Delivering The Promise Of Gene Therapy

  Gene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.