Articles

This section includes the latest articles from American Pharmaceutical Review magazine. Articles featured in this section cover a wide range of topics of critical interest to the biopharm and pharmaceutical industries. From R&D strategies, meeting regulatory requirements, and new insights into manufacturing efficiencies, the articles featured here will give you the insight and knowledge needed to bring the latest medicines to market.

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  • What Does It Mean to Be A Full-service Cdmo?

    Tuesday, September 29, 2015
    Numerous trends in the pharmaceutical industry are driving drug manufacturers to outsourcing more activities, from discovery through commercial production and even life cycle management. In many cases they are ... read more

  • Cultural Competence In Pharma

    Tuesday, September 29, 2015
    The healthcare industry is in the midst of a turbulent global transformation, and with the advent of technology and the ability to reach consumers across country boundaries, cultural-value-based strategy and ... read more

  • In-depth Process and Product Expertise

    Tuesday, September 29, 2015
    As older blockbuster drugs lose patent protection and generic competition increases, many pharmaceutical companies are focusing discovery efforts on therapies with the potential to treat multiple niche populations. ... read more

  • Special Focus–Achieving Strong Customer Perception

    Tuesday, September 29, 2015
    The Nice Insight Pharmaceutical and Biotechnology Survey is deployed to outsourcing-facing pharmaceutical and biotechnology executives each year. Customer Perception (CP) of CRO/CMO/CDMOs is a major focus of the ... read more

  • Outsourcing Provides Advantages to Sponsor Companies

    Tuesday, September 29, 2015
    The pharmaceutical contract manufacturing industry is undergoing some important changes that reflect the current evolution of the pharmaceutical industry. An emphasis on cost control, a shift in growth from mature to... read more

  • Be Innovative! Maneuvering the Global Pharmaceutical Market

    Tuesday, September 29, 2015
    The recent spike of patent cliffs has made a huge dent in pharma sales revenue. To recoup the loss and sustain market position, pharma companies are in the race for new drugs. The hunt for the next blockbuster has ... read more

  • LER Frequently Asked Questions

    Tuesday, August 25, 2015
    Since the initial reports of Low Endotoxin Recovery (LER) in 2013 drug manufacturers and regulators have voiced concern that there may be conditions under which the Bacterial Endotoxins Test (BET) could under-report ... read more

  • Endotoxin Detection Methods – Where are we now?

    Tuesday, August 25, 2015
    The test methods used to detect and quantify endotoxin have evolved over the years to provide us with improved sensitivity in detection and opportunities for obtaining results in real time. Present endotoxin detection ... read more

  • Microbiological Attributes of Powdered Cannabis

    Friday, July 31, 2015
    Although marijuana is classified as a Schedule I drug “having no medical use, with a high potential for abuse” by the U.S. Federal Drug Enforcement Administration, Western States including Colorado, Alaska, Oregon and ... read more

  • Monoclonal Antibody Targets and Indications

    Friday, July 31, 2015
    The past thirty years have witnessed an impressive growth in sales of therapeutic monoclonal antibody (MAb) products. This growth of MAbs as a class of therapeutics was made possible in part by the development of large-... read more

  • The Road to the Biological IND

    Friday, July 31, 2015
    Numerous elements are needed to bring a promising therapeutic protein from research through development, analysis, manufacturing, and quality control (QC) and assurance (QA) for a successful IND application. read more

  • Conducting Microbial Investigations

    Friday, July 31, 2015
    Many methods and tools used in the modern pharmaceutical microbiology laboratory were derived in the nineteenth century. The methods may not seem to be complicated, but are effective and still used. For example, tools ... read more

  • CAPA Implementation: The Human Effect

    Friday, July 31, 2015
    The implementation of CAPAs (Corrective and Preventive Actions) in Phase 3 clinical trials presents some considerations less common in the better-controlled areas of pharma. read more

  • Continuous Manufacturing, Near Infrared Spectroscopy and Process Knowledge

    Friday, July 31, 2015
    Continuous manufacturing was one of the topics discussed at the XXXV Symposium of Spain Industrial Pharmacists Association (AEFI - Asociación Española de Farmacéuticos de la Industria) in Barcelona. The leitmotif of the ... read more

  • Good Things Come in Small Packages: Hand-Held Raman Instruments Come of Age

    Friday, July 31, 2015
    While the Raman effect has been in college curricula for decades, for much of that time, it has been considered a research tool. The early (c. 1970) models were driven by quite powerful LASERs and had a nasty habit of ... read more
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