1. A Risk-Based Approach To Environmental Monitoring & Control For Pharmaceutical Distribution

    Over the past few decades, many companies have spent time and capital investment in assessing and mitigating risk factors across the extended supply chain. However, even for those companies that have designed and implemented state-of-the-art operational supply and logistics networks, there is always risk that products may be impacted by variations in temperature, humidity, or other deviations from ideal conditions at any stage across the chain of custody.

  2. Research Informatics In The Cloud: Are You Ready?

    Join BIOVIA for a complimentary lunch in Princeton, NJ (Nov 15) or Boston, MA (Nov 16) and learn how BIOVIA is helping pharma, biotech and agrochemical organizations execute on their cloud strategy to become more agile, lower total cost of ownership and collaborate more effectively.

  3. Single-Use Continuous Manufacturing: The New Paradigm In Biopharmaceutical Processing

    Two significant trends in biopharmaceutical production are coming together. For years, single-use systems have been gaining traction as a way to make processing of biotherapies more efficient. More recently, the industry has also been eyeing continuous manufacturing options to replace traditional “batch” processing methods — again, with the goal of obtaining greater efficiencies.

  4. Single-Use Mixer For Difficult-To-Mix Biopharm Ingredients

    MilliporeSigma’s Mobius® Power MIX 2000 single-use mixing system is engineered with advanced technology to effectively handle difficult-to-mix buffers, culture media powders and other pharmaceutical ingredients. The Mobius® Power MIX achieves a strong vortex using an impeller design and motor based on magnetically-coupled NovAseptic® technology, a proven mixing technology in stainless steel tanks. The Power MIX 2000 provides accessible, sterile zero deadleg sampling directly from the mixing container. A Probe Port allows for insertion of either a reusable probe for non-aseptic processes or a pre-sterilized, single-use sensor for in-process pH measurement of aseptic processes. Other design features make the mixing system easy to use, enabling loading of bags by one person and offering an optional integrated hoist for powder delivery.

  5. Utility System Design Considerations For Single-Use Bioprocessing

    Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the fourth in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.

  6. Quality Systems 101: Basic Concepts & Considerations

    Whether you are a life science startup with a brick-and-mortar office or working as a virtual company, at some point the question comes up: Do we need a quality system? Or perhaps your question is, What is a quality system?

  7. 6 Tips For Better Time Management In Pharmaceutical Operations

    We all want to maximize the productive use of our time, correct? Over the span of my pharmaceutical industry career, I have been fascinated with this topic. It started when one of my supervisors in supply chain gave copies of The 7 Habits of Highly Effective People to me and the rest of his staff, which became one of many books on time management I have read.

  8. Continuous Bioprocessing Overtakes Single-Use On List Of Top Technology Trends

    The desire for innovation in the biopharmaceutical manufacturing industry continues unabated, as companies ramp up their spending on new technologies to improve efficiencies in both upstream and downstream bioprocessing. And while innovation in this industry can be slow to come, the past decade has seen the emergence of several new innovative trends, ranging from the proliferation of single-use devices to growing demand for continuous bioprocessing and modular facilities, according to BioPlan Associates’ 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

  9. What Recent FDA Enforcement Actions In The EU Mean For FDA/EMA Cooperation

    FDA and the EU have taken serious enforcement actions against firms in the other’s geographic jurisdiction during the calendar year 2016. In the preceding article, we looked at European inspectorate actions against sites in the U.S. Issues identified as problematic included deficiencies in aseptic processing of parenteral drugs, data integrity concerns, lack of controls to prevent cross-contamination, and failure to adequately address observations from previous inspections. FDA had inspected each of the three facilities within the past year.

  10. The Practical Application Of Home Healthcare

    Recruiting patients and retaining their participation in a clinical trial remain the biggest challenges faced by pharmaceutical companies when developing new medicines. For a patient, participation in a clinical trial can be stressful and burdensome, resulting in one in four patients dropping out of a clinical trial prior to completion. With sponsors facing tight-timelines, increased regulatory scrutiny and spiralling budgets the desire to address these challenges has never been more prominent.