ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Using 505(B)(2) To Streamline Approval Of Combination Products

  In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Achieving EU GMP Annex 1 Compliance For Contamination Control

  Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

• The Benefits Of Transparent Pricing

  Streamline biopharma budgeting and expose hidden contract manufacturing fees. An all-inclusive pricing model ensures predictable partnerships from initial scale-up to commercial approval.

• NovaPure Stoppers - The Right Choice For Oncology Drugs

  Vial containment systems with NovaPure® elastomer stoppers offer substantial performance benefits with their enhanced dimension control, reduced particle levels, inspection of every stopper, and use of FluroTec® film. Explore the performance of the film and why NovaPure stoppers should be the choice for sensitive drug products.

• Low Temperature Storage Containment For Vial And Syringe Systems

  With the growth of advanced therapy medicinal products, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50°C to ≤ -130°C.

• 3D Printing Of Pharmaceutical Dosage Forms – Has The Time Come?

  Additive manufacturing, or 3D printing, is arguably balancing on the cusp of translation from academic research into industry practice for pharmaceuticals. What will the future impact of 3D printing be?

• Advancing A LNP Formulation To Clinical And Commercial Manufacturing

  Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

• Container Closure Integrity Evaluation For Cell And Gene Therapies

  With the growth of gene and cell therapies, there is an increased need to characterize container closure systems at the low temperatures experienced during their lifecycles.

• Beyond The Battery: Powering the Next Generation Of Active Implants

  Active implants are pushing past battery limits as energy‑harvesting taps motion, heat, and biochemical signals. Hybrid systems could shrink devices and enable longer‑lasting, self‑powered implants.