Industry Insights

  1. What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?

    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. The Direct-To-Patient Model: Your Top 10 Q&A

    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.

  3. End-to-end Technology Transfer Services In Oral Solids And Sterile

    In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.

  4. A Guide To The Development Of Monoclonal Antibodies (mAb) Purification Platforms

    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.

  5. How Does The FDA's Process Validation Guidance Simplify A Technology Transfer?

    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.

  6. What Is A Technology Transfer And How To Ensure A Successful Transfer - Part 1

    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.

  7. CSS Archiving Project With Billions Of Clinical Trial Data Pieces - Infographic

    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.

  8. Good Manufacturing Practice: The DNA of Pharmaceutical Quality

    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. 

  9. Top Considerations For Selecting The Right Packaging

    Determining a product’s temperature range is the first crucial step in packaging evaluation. While vacuum insulated panels (VIPs) with phase change materials (PCMs) remain the gold standard of temperature-controlled transport, many high-value products in today’s market have components that require storage at extreme temperatures — as low as -196°C.

  10. What Is The Best Way To Develop An RFP?

    When a pharmaceutical company has a drug product and is in search of a contract manufacturing site to make its product, it usually puts out a request for proposals (RFP) to gather information regarding time, cost and the organization. While this might sound routine, the truth is that a mediocre, poorly organized RFP has the potential to slow the process of selecting the right manufacturer, drive up technology transfer and commercial product costs and also negatively impact the relationship between the sponsor and the manufacturer.