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  1. 5 Key Takeaways From The FDA's Revised Quality Metrics Guidance
    2/23/2017

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

  2. 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)
    2/21/2017

    Microbial contamination control is essential in ensuring consumer safety, especially in controlled environments. Disinfectants play an important role in controlling microbial contamination on surfaces. The term disinfectant is often broadly used to describe chemical agents used to reduce the microbial load of controlled environments.

  3. Overcoming The Manufacturing Hurdles Of Cell & Gene Therapy
    2/20/2017

    A number of innovative cellular and gene therapies are in development, and R&D and investments in these fields are rapidly growing. Although the number of approvals and markets remain very small — negligible by the standards of the mainstream (bio)pharmaceutical industry — this is likely to change as the first clinical trials are successfully concluded.

  4. 7 Steps To Navigate Six Sigma’s “Improve” Phase
    2/17/2017

    In this series, we’ve covered quite a bit of ground in providing a working understanding of Six Sigma and its DMAIC (Define, Measure, Analyze, Improve, Control) roadmap for problem solving and product/process improvement.

  5. An Alternative To Achieve Speed And Scalability To Microbial Expression For Next-Gen Therapeutics
    2/17/2017

    The newly developed G1-3 fermentation process makes use of short, straightforward fermentation regimes for optimized space time yield.

  6. Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances
    2/15/2017

    Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements. Ideally, these documents would have aided industry in developing new products that take advantage of new technologies, given budget and personnel limitations in both the regulatory agencies and industry. And in fact, many of these documents have proposed or emphasized radical changes in strategy and operations, but unfortunately such changes are often met with skepticism and concern by industry.

  7. Automation, Modularity Allow mAb Biotech To Cut Scale-Up Time
    2/14/2017

    Biomanufacturers, especially those facing the debut of biosimilars in core markets, have an urgent imperative to reduce manufacturing costs via increased productivity and yields. In turn, this drives a wide range of business decisions, including capital investment, process choices and design, and equipment selection. Learn how AlphaMab Co. Ltd, a fast-growing bio-developer and producer, cut scale-up time using a Quality by Design (QbD) approach.

  8. Simple Transfer Of An Itaconate Production Process
    2/14/2017

    The unsaturated dicarboxylic acid itaconate is used as a building block for the production of pharmaceuticals and adhesives, as a copolymer for synthetic resins, and is a promising starting material for biofuel production.

  9. Automatic Fermentation For Microbial And Mammalian Cultures
    2/14/2017

    The Auto Culture modes, standard on the BioFlo 120 bioprocess control station, offer push-button automatic process control for some of the most common microbial and mammalian (Chinese Hamster Ovary) cultures.

  10. Launching A New Drug In A Maturing Market — Lessons Learned From Recent COPD Entrants
    2/10/2017

    Chronic obstructive pulmonary disease (COPD), a global growth market worth well over $15 billion in the U.S. and EU5 in 2016, has long represented a lucrative opportunity for drug manufacturers. However, the proliferation of treatments and increasing number of generics have begun to limit the potential for emerging therapies. A review of the successes and stumbles of the newest class of drugs (LABA/LAMA fixed-dose combinations) illustrates broader lessons manufacturers should consider when launching into a rapidly maturing market.