Application Notes & Case Studies

  1. A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations
    6/10/2019

    Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

  2. Comparing Continuous And Batch Processing In Downstream Purification
    6/10/2019

    Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

  3. Customized Labelling Solution Delivers Seamless Trial
    5/24/2019

    Clinical labelling is a function that has the potential to make or break a study, depending upon design and execution. A function that was once seemingly on the periphery of clinical trial management has now taken on a new level of significance with increasingly complex labelling requirements. This case study highlights the complexities involved in label design and execution and how Almac worked with one sponsor to identify and rectify a flawed design to ensure a seamless trial, an improved patient experience and enhanced overall trial performance.

  4. Putting Patients First By Introducing Supply Chain Visibility And Efficiency To Investigator Initiated Trials
    5/14/2019

    Investigator Initiated Trials (IITs) play an important role in helping sponsor companies better understand their drugs. However, managing these studies presents unique and complex clinical supply chain challenges. Download the case study to find out how Almac Clinical Services helped one biotechnology company effectively manage drug supply for multiple IIT programs.

  5. Direct-To-Representative Sample Distribution Services
    4/30/2019

    Pharmaceutical manufacturers use a range of marketing channels to promote their prescription drug product. One proven and particularly effective appraoch is to have pharmaceutical sales representatives ‘hand carry’ samples to the health care practitioners within their territories.

  6. How A CRO-EDC Partnership Got Results For Study Sponsors
    4/29/2019

    To deliver consistent results and ultimately create lasting relationships with sponsors, ARA needed fast and flexible eClinical tools. Medrio offered the ability to set up studies easily, collect data accurately, and make mid-study changes without study downtime saves their clients time and money - and increases the likelihood of repeat business and referrals.

  7. A Successful DDC Implementation That Any Organization Should Aspire To
    4/29/2019

    Learn how a Phase I unit in Australia leverages Medrio DDC to reduce paper usage by 95% and monitoring visits by 50%. This case study provides holistic insight into DDC vendor selection, implementation, and results.

  8. A Patient-Centric Approach Rescues Complex TBI Study
    4/24/2019

    Site selection and ensuring that sites are performing up to par are crucial parts of a study. Read how a CRO facilitated communication between participants and sites and personally took measures to follow up with participants who would have been otherwise lost between screening visits.

  9. Strict Processes Rescue Complex MS Trial
    4/23/2019

    A specialty pharmaceutical company engaged Biorasi to rescue their phase 2 clinical trial for treatment of spasticity caused by multiple sclerosis (MS) after an incumbent CRO was not meeting enrollment expectations. Read how Biorasi’s project management-first approach allowed rapid feasibility and site startup to meet critical deadlines.

  10. An Innovative Approach To Solve An RLD Shortage
    4/23/2019

    Limited or no availability of the Reference Listed Drug (RLD) for a generic dermatology trial can seriously hinder the feasibility of a study. An innovative approach including the enrollment of patients with very high potential of protocol adherence and effective patient engagement to minimize the rate of retreatment throughout the study resulted in a successful study.