Articles, App Notes, Case Studies, & White Papers

  1. Contract Design And Development Vs. In-House: How To Find The Best Fit 3/21/2024

    Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.

  2. The Importance Of A Human Centered Approach To Product Development

    To meet the needs of patients, life-saving device innovations are needed for the next generation of delivery devices. As drug manufacturers explore the device world, human factors are a key consideration.

  3. Steps To Overcome Challenges Associated With Biologic Formulation Development 8/24/2022

    Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).

  4. Design Verification Testing Of Combination Products 7/12/2024

    Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.

  5. Sophisticated Formulation Approaches For Insoluble Drug Candidates 1/24/2022

    A sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.

  6. 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.

  7. Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

    Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

  8. Monoclonal Vs Polyclonal Antibody Production- Explained Step By Step 6/17/2026

    Selecting the optimal antibody framework is critical. Discover how monoclonal and polyclonal epitope specificity impacts manufacturing complexity, batch uniformity, and long-term therapeutic efficacy.

  9. The Importance Of An Analytical Testing Strategy

    A proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.

  10. Taking A Best Practice Approach To Contamination Control  9/21/2025

    Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.