Downloads

  1. 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 2)
    3/22/2017

    This article explains the critical components of a compliant disinfectant efficacy testing package in the U.S.,  along with tips for assembling the package.

  2. How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)
    3/20/2017

    Whether you read Part 1 of this three-part series — and sought pre-IND (Investigational New Drug) feedback from the FDA — or not, let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time.

  3. Praesto® HT Columns
    3/17/2017

    HT Columns from Purolite Life Sciences streamline your separations.

  4. Praesto® HT Columns
    3/17/2017

    Pre-packed with your choice of Praesto modern, high-flow agarose resin for cost-effective, high productivity MAb purification.

  5. What Outcomes-Based Contracting Means For Drug Development & Drug Pricing
    3/17/2017

    The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower list prices and curtail price increases or face government controls.

  6. Antibody Drug Conjugates: Products. Services. Expertise.
    3/16/2017

    The development journey of an Antibody Drug Conjugate (ADC) is complex and remarkably challenging: it requires linking a unique, tumor targeted monoclonal antibody (mAb) to a potent, cell killing cytotoxic small molecule drug. This requires expertise in small and large molecule development, manufacturing, formulation and testing. Choosing an experienced partner, with these skills and the required containment facilities can help advance your ADC to market.

  7. Pfizer Uses Single-Use Collaboration To Achieve Speed To Market Goals
    3/16/2017

    As Pfizer began its pursuit of delivering two biosimilar monoclonal antibodies (mAbs) in China, it sought a partner that could mitigate the risks of expanding into this region while also significantly reducing the development timeline. By leveraging the expertise of an experienced partner and the benefits of single-use technology (SUT), Pfizer was able to quickly establish a global footprint while also gaining a competitive advantage in an emerging market.

  8. Are You Prepared For The Upcoming USP <800> Requirements?
    3/15/2017

    The United States Pharmacopeial Convention (USP) has developed a chapter on hazardous drug (HD) handling in healthcare, USP <800>, which will become effective on July 1, 2018. For facilities that handle hazardous drugs, there’s no time to waste in working toward compliance, because facility design/redesign and construction may be necessary to achieve it.  USP chapters numbered less than <1000> are requirements, not guidelines, in the United States, so compliance is necessary.

  9. Lowering MAb Clinical Trial Material Manufacturing Costs With Protein A Chromatography Resins
    3/14/2017

    It is well recognized that the cost of that the use of Protein A chromatography resins in biopharmaceutical manufacturing is substantial. However, a high percentage of clinical projects will fail, resulting in the Protein A resin only being used for a small number of cycles – significantly reducing cost-efficiencies

  10. The Small Pharma–CDMO Marriage: How We Can Make It Even Better
    3/13/2017

    Unlike Big Pharma, which may outsource internally developed processes and formulations, small and midsize pharma/biotech firms are dependent on contract development and manufacturing organizations (CDMOs) for much of their product development and GMP manufacturing activity.