1. Process of the Future: Cheaper, Faster and Safer With Single-Use

    Cell culture transfer from one vial to containers such as T-flasks or shake flasks, and then to the bioreactor, is usually one of these open phases. These critical steps may take several days or even weeks, and can results in delays if a contamination occurs.

  2. Is GMP Quality System Auditing Fundamentally Flawed? — A Data Integrity Alternative

    A quality systems approach to GMP auditing has become common practice among both regulatory authorities and internal audit programs at pharmaceutical companies. The method originated with the FDA Center for Devices and Radiological Health’s (CDRH) Quality System Inspection Technique (QSIT), introduced to the medical device industry in August 1999, and was later adopted by the Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER) for pharmaceutical drug inspections.

  3. 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015).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.

  4. 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

    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.

  5. Overcoming The Manufacturing Hurdles Of Cell & Gene Therapy

    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.

  6. 7 Steps To Navigate Six Sigma’s “Improve” Phase

    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.

  7. An Alternative To Achieve Speed And Scalability To Microbial Expression For Next-Gen Therapeutics

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

  8. Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances

    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.

  9. Automation, Modularity Allow mAb Biotech To Cut Scale-Up Time

    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.

  10. Simple Transfer Of An Itaconate Production Process

    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.