Application Notes & Case Studies

  1. Zydis® ODT - Improved Therapeutic Profile

    Zydis® fast dissolve formulation for Zelapar® (Selegiline anti-Parkinson’s compound) had a positive impact on the patient compliance as compared to the Selegiline traditional tablets.

  2. Revolutionizing Allergy Therapy

    ALK-Abelló is a global research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. Before ALK-Abelló partnered with Catalent, all marketed allergen immunotherapies were delivered by injection, resulting in a limited patient population and reduced patient adherence. Catalent worked with the client to apply Zydis Fast Dissolve Technology to their therapy. The overall result was a marked improvement in patient tolerability, preference and compliance.

  3. Feasibility Of Shipping Clinical Trial Drugs Directly To Patients’ Homes

    Conducting clinical trials for rare, debilitating diseases can be particularly challenging, owing to the smaller patient population with limited mobility and greater caregiving requirements. Direct-to-patient shipping of clinical trial drugs, while not typical, might help to reach these patient populations who otherwise would struggle to participate in and comply with clinical trials. However, implementation of this strategy is challenging because of many reasons such as the logistical considerations and regulatory requirements regarding patient confidentiality and quality control. Recently, Bioclinica collaborated with a sponsor to successfully ship study drugs directly to patients.

  4. eTMF: Intelligent Submissions of Regulatory Filings

    A leading global contract research organization (CRO) was manually uploading site documents and associated metadata into their eTMF. Due to the complexity of (SSU) and variability of regulatory requirements for study countries and therapeutic areas, determining when all the documents needed for filing existed in the eTMF without multiple QC checks was a time consuming and burdensome activity. As the organization scaled with additional study volume, the efficiency and quality of the data going into the eTMF was causing audit risk and increasing FTE costs.

  5. Achieve Continuous Supply Of Drug Treatment For Study Requirements

    A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.

  6. Solutions For Challenging Compounds Using Softgel Innovation

    The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems. 

  7. Expediting A Promising New Therapy

    An innovative biotechnology company exploring novel therapeutics for neuroscience indications had developed a promising new chemical entity for the treatment of a severe pediatric genetic disease.

  8. Versatility Of Softgel Technology: The Encapsulation Of A Volatile Compound

    A commercial stage medical technology company has developed SMART Softgels featuring a special shell to release quickly while still preventing evaporative loss during and after manufacturing. 

  9. Enable Oral Delivery Of Synthetic Oligosaccharides

    Due to their poor oral bioavailability, oligosaccharides are formulated as solutions or suspensions and delivered by invasive intravenous (IV) or subcutaneous injection.

  10. Modernizing Clinical Trial Management

    Accelovance is a global company that oversees hundreds of clinical trial activities. Manual data entry was taking up hours of employees' time as well as adding unnecessary complexity and risk to the clinical trial process. In this case study, learn how the move to automation saved 90 operational hours per month, enabled staff to focus on other strategic endeavors, and provided actionable data that led to winning new business for the company.