Industry Insights

  1. What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?
    6/4/2015

    When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed. 

  2. Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies
    5/30/2015

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  3. Shift From Central Lab To POC
    11/22/2016

    As new technologies work to change the market space, this article takes a look at the market forces that are helping and hindering the shift to zero wait time for patient test results. Comprehensive analysis of both test settings allows for better understanding of the diagnostic landscape as it exists today, offering insight to both product and process innovations for your next generation product.

  4. The Direct-To-Patient Model: Your Top 10 Q&A
    9/2/2016

    In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.

  5. NEW DOCUMENT
    12/5/2016

    Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.

     

  6. A Guide To The Development Of Monoclonal Antibodies (mAb) Purification Platforms
    8/11/2016

    The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.

  7. How Does The FDA's Process Validation Guidance Simplify A Technology Transfer?
    8/3/2016

    The technology transfer of a process, whether it is from R&D to commercial manufacturing or from one manufacturing site to another, is a critical step in the life cycle of any drug product.

  8. What Is A Technology Transfer And How To Ensure A Successful Transfer - Part 1
    5/10/2016

    Current market conditions, as well as a myriad other factors, have increasingly prompted drug developers to establish complex supply chains to ensure the commercial-scale manufacture of the compounds they’ve created. Perhaps one of the most important links in any contemporary supply chain is the one between drug owners and the contract manufacturing organizations (CMOs) they partner with to ensure that supply will meet the demand for their therapies. When it comes to these relationships, success hinges on several critical factors, but chief among them involves getting a highly critical process right: the technology transfer.

  9. CSS Archiving Project With Billions Of Clinical Trial Data Pieces - Infographic
    5/13/2016

    The CSS Archiving Project s a massive undertaking, containing thousands of trials and billions of trial data pieces from 14 locations all over the world.  With this project in place, World Courier will be able to take client's trial records and either return them, destroy them or archive them in a long-term storage.

  10. Good Manufacturing Practice: The DNA of Pharmaceutical Quality
    7/16/2015

    Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs.