Outsourced Pharma White Papers

  1. How To Avoid High Potency API Contamination 3/22/2019

    To ensure that employee exposures are kept within accepted limits and protect the environment while containing costs, pharmaceutical companies and their contract partners who manufacture and handle high containment compounds must carefully select equipment, outline processes and procedures, and deploy appropriate containment technologies. Having standards in place for engineering controls is the first line of defense against harm from cross contamination or exposure to the patient, manufacturing employees, or the environment when working with HPAPIs.In this paper learn how to determine exposure potential and select the correct equipment and technology.

  2. In-House Versus Outsource: A Decision-Making Guide 5/2/2018
    Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
  3. Avoiding Hemolysis Blood Sample Collection Processing 2/11/2019

    Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.

  4. Off-Site Storage Of Biological Specimens And Biologics For Risk Mitigation 2/11/2019

    Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.

  5. Quality Matters – SEC Analysis For Antibody Aggregates 10/25/2019

    Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

  6. Fluid Bed Granulation And Melt Granulation In Pharma Manufacturing 3/19/2019

    Affording superior reproducibility and control than other granulation techniques, fluid bed granulation and melt granulation can be tightly regulated to produce uniform material with a specified particle size.

  7. Component Selection: The Key To Your Program Success 10/1/2019

    The increasing global adoption of injectable medicines creates demand for pre-filled syringes and vials. CDMOs that provide aseptic fill and finish services are actively responding to this increased demand.

  8. Optimizing Process Efficiency In Upstream Manufacturing 2/8/2019

    Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.

  9. Embedding Your Drug Strategy Within A Solid Foundation For Success 3/24/2020

    This white paper looks at the broad set of trends influencing pharmaceutical development and manufacturing strategy today, and how these drivers are influencing new business models with outsourced partners. It highlights the inherent value proposition of embedded CDMOs, and how this business model is helping to optimize drug substance and drug product development and commercial manufacture.

  10. Utilizing External Collaboration To Accelerate Vaccine Development 11/2/2018

    Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.