Articles, App Notes, Case Studies, & White Papers

  1. From Innovator To Partners In Cell Therapy: Our Evolution Into A CDMO

    Explore the common pitfalls encountered in CGT CDMO collaborations, including communication breakdowns, differing regulatory interpretations, and program prioritization challenges.

  2. Safely Navigating The Transition From MDD To MDR 7/25/2025

    If devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.

  3. Keys To Driving Consistent Quality In Contract Manufacturing 1/30/2019

    Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.

  4. 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.

  5. Evolution Of Novel Polymers To Overcome Limits In Sustained Drug Delivery 10/24/2022

    Degradable polymers evolved from aliphatic polyesters to nitrogen-bearing biomaterials such as polyurethanes and polyester amides. Explore a brief history of the development of PEA polymers.

  6. How Subcutaneous Delivery Can Help Patients Manage Chronic Conditions

    Read more about how to improve your patients’ outcomes, avoid costly delays to launch, and provide a better return on investment.

  7. Reliable Components For The Lifecycle Of Your Injectable Drug Product

    As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.

  8. Effects Of Annex 1 Revisions On Manufacturing Operations 12/1/2022

    The revisions to EU Annex 1 set the stage for the future direction of the pharma/biotech industry. Explore some of the key takeaways and interesting changes for risk management and contamination control strategies.

  9. Age-Appropriate Pediatric Formulation Development 1/27/2022

    There is a significant variability in the pharmacokinetics of the same drug and dosage form between pediatric and adult populations, and the factors impacting drug bioavailability are different in children.

  10. How To Find The Right Balance In Cell Therapy Manufacturing 5/20/2024

    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.