Articles, App Notes, Case Studies, & White Papers

1. Achieve Release Profiles And Select Excipients For Formulation Development 5/2/2020

   The formulation and manufacture of modified-release OSD forms are highly specialized. Review considerations for planning and executing a successful modified release oral solid dosage formulation.

2. 4 Factors Affecting Solubility Of Drugs 2/28/2022

   Improper drug solubility can lead to suboptimal drug delivery and absorption, resulting in ineffective drug efficacy and side effects, so solubility must be evaluated in the early stages of drug discovery.

3. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

   A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

4. Nanoparticle Engineering Addresses The Challenge Of Poor Aqueous Solubility 3/24/2023

   As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.

5. Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

   This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.

6. Compliance Considerations For Emergency-Use Delivery Systems 5/2/2022

   Because auto-injectors are typically the delivery device of choice for emergency medications, they come with increased scrutiny from regulatory bodies regarding their safety and effectiveness.

7. Planning For Scale Up: Building For Long Term Flexibility 8/31/2026

   Decisions made during clinical manufacturing have lasting consequences at commercial scale. This article examines how fill/finish equipment choices shape long-term flexibility, throughput, and operational continuity.

8. An Elegant Solution For Delivery Of Acid Sensitive Pharmaceuticals 12/6/2022

   Sustained release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.

9. What's Standing In The Way Of Mainstream NAMs Adoption? 5/19/2026

   NAM adoption is constrained by inconsistent cell sourcing, limited standardization, and regulatory uncertainty — barriers that must be addressed to enable reproducible evidence and regulatory trust.

10. Design And Packaging Advantages For Cell And Gene Therapy Drugs 9/3/2024

    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.