July/August 2014

Volume 15, Issue 4


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Articles in this Issue

  • Building the Turnkey Product CMO

    Jim Miller
    The recent acquisition of Oso Biopharmaceuticals (Albuquerque, NM) by Albany Molecular Research Inc. (AMRI – Albany, NY) gave AMRI the ability to offer bio/pharma companies a single source for supply of a product’s API and dosage form. This turnkey product offering is becoming more common in the contract manufacturing industry, and the desire to build such a “one-stop shop” may drive a lot of merger and acquisition activity in the CMO industry.
  • 5 Steps to Reduce Temperature Excursions for Pharmaceutical Products

    Rafik H. Bishara, Ph.D., Travis Hudson, Désirée Valentine
    Many risk factors impact the products that pass through the Pharmaceutical Supply Chain. While these risks can be adequately mitigated, many are out of the shipper’s direct control. To experience success when distributing temperature-controlled pharmaceutical products, a firm must first control all aspects of the process within its walls. Then the firm must forge solid working relationships with partners in the supply chain to work together as one cohesive team.
  • Third-Party Manufacturing— From Concept to Contract

    Peter Murray
    The pharmaceutical supply chain starts with supply of active ingredients or components and continues through various stages of dose form manufacture, packaging, and testing before the goods are transported to a distribution center. Some key factors now challenge the traditional model of a pharmaceutical company conducting a large proportion of activities in-house. Ensuring security of supply, the need for specialist capabilities, in-licensing, product lifecycle management, market access, and cost optimization are just a few of these factors.
  • Establishing the pH of Extraction Solvents Used to Simulate Aqueous Parenteral Drug Products...

    Dennis Jenke, Ph.D.
    Substances that leach into drug products from their associated packaging system can potentially affect the suitability of the drug product for its intended use. Thus drug products may be tested for leachables to establish whether the leachables achieve levels in the drug product that are sufficiently high that they discernibly impact the product’s suitability for use.
  • API Roundtable

    Targeted therapies in oncology API development and manufacturing continues to be a growing trend. The pipeline of antibody-drug conjugates is expansive, and the ability to handle the diverse manufacturing requirements will be a differentiator in the CDMO industry. The emergence of biosimilars into the biologics sector of the oncology market will also be a key development to watch, to track how the industry manages the competitive landscape unique to each region.
  • Relative Success Rates by Drug Class: The Case for Peptides

    Laszlo Otvos, Ph.D.
    The success rates of drugs during various phases of the clinical development pipeline are crucial benchmarks for valuation models in the pharmaceutical investment community.
  • A Survey of Expatriated Brazilian Clinical Research Professionals Working Outside Brazil

    Eduardo F. Motti, M.D., Maria Lucia C. Pecoraro, MD
    Biomedical research has a long tradition in Brazil. Since the final decades of the 19th century, Europeans and Brazilian researchers were responsible for notable scientific advances such as the work published by Carlos Chagas, which led to the description of the etiology, the vector, transmission mode, and the clinical presentation of the trypanosomiasis, now known as Chagas' Disease [1], and others related to leishmaniasis, schistosomiasis, etc. Clinical research (CR), however, especially targeting the development of new treatments, did not receive similar emphasis from Brazilian researchers.
  • Collaborative Models for Managing Research Samples in China

    Lori Ball, Terrence Fisher
    While China represents a number of advantages and a strong environment for clinical research, including vast patient populations and fast patient recruitment, there are still a number of obstacles that present significant challenges to pharmaceutical companies conducting research in the region. Particularly, the collection and management of human samples and associated data has become a complex landscape to navigate for drug developers in the region.
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