Articles, App Notes, Case Studies, & White Papers

  1. Partnering With Clinicians To Improve Pediatric Formulation Development 6/13/2022

    Greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products.

  2. Computational Modeling Of Injection-Related Tissue Responses 6/15/2022

    Optimizing delivery along with the formulation is the key to successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force, and needle length.

  3. 5 Novel Techniques For Solubility Enhancement 2/28/2022

    Thanks to insoluble drug delivery technologies, the practice of reformulating poorly soluble drug products to improve efficacy, patient compliance and safety has now been widely adopted.

  4. Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives 7/17/2024

    A gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.

  5. How Various Clinical Study Stages Influence Oral Formulation Approach 4/6/2022

    It’s important for pharmaceutical and biopharmaceutical companies to implement a phase-appropriate approach for early formulation development and later-stage commercial development.

  6. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

    It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

  7. Maintaining Superior Viral Vector Recovery In Cell And Gene Therapy Applications 9/3/2024

    A study assessing the stability of vials aimed to determine if the vial material had any influence on the viral titer and particle counts of the AAV serotypes.

  8. How A Flexible Approach To Autoinjector Assembly Can Be Advantageous 7/7/2023

    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.

  9. Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing 6/1/2022

    Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.

  10. Using 505(B)(2) To Streamline Approval Of Combination Products 2/2/2023

    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.