ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Elastomer Plungers With Barrier Film For COVID-19 Vaccines

  Minimize the risks of accelerated drug development processes and the potential use of new vaccine platform technologies with the use of an elastomer plunger laminated with FluroTec™ barrier film.

• A Risk-Based Approach To Injectable Combination Product Development

  Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

• 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.

• Spray Drying: Advantages And Disadvantages

  When it comes to formulation development, pharmaceutical spray drying is one of the most versatile solutions. Review a detailed look at the steps involved in spray drying and the benefits and downsides.

• How A Flexible Approach To Autoinjector Assembly Can Be Advantageous

  Examine how a flexible, scalable, and efficient solution for the assembly of autoinjectors can help you stay ahead of the competition and meet the demands of an ever-changing industry.

• 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.

• Solubility With Lipid-Based Technologies For Oral & Injectable Formulations

  Innovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.

• Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics

  All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

• Capsule Formulation Development: From Dosage Forms To Filling

  Capsules are tasteless and easy to take, offer streamlined development timelines, and simplicity of manufacturing. Discover capsule formulation development and the benefits of capsule dosage forms.