Industry Insights

  1. Applying QRM To The Change Control Process

    Since the publication of ICH Q9: Quality Risk Management in 2005 (1), there has been much written about the application of risk management to the production process, product development and validation (2–5). Relatively little has been published about its application to some of production’s supporting processes that comprise an important part of the pharmaceutical quality system (PQS).

  2. Can Assumption-Free Batch Modeling Eliminate Processing Uncertainties?

    Monitoring batch processes to ensure the highest level of quality is imperative. While periodic batch process control is the traditional approach to managing consistency end quality, it is recipe-driven. 

  3. The Future Is “Cloudy” For Data Integrity In Life Sciences

    Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.

  4. Designing A Biomanufacturing Facility Incorporating Single-Use Technologies

    When building a new facility based on single-use technologies, or incorporating single-use into an existing facility, how do companies ensure they fully realize the benefits?

  5. 12 Ways To Reduce Data Integrity Risk

    Data integrity has become a serious issue over the past few years and therefore is a core focus of many enterprises. The FDA published a Data Integrity Guidance Document outlining compliance with CGMP that addresses the role of data integrity for industry.

  6. Which Test Is Appropriate For Container Closure Integrity?

    Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.

  7. How Global Pharma Orgs Can Achieve Process Validation Success

    The pharmaceutical market has transformed into a global industry within the span of just a few decades. Many companies have sites across the globe, presenting challenges when it comes to harmonizing process validation approaches among sites. There are numerous solutions available to ensure effective process validation at sites within a global network. No matter the solution, a comprehensive process validation strategy is necessary to achieve success.

  8. Sanofi Asks — Will Standardization Take End User & Supplier Relationships To The Next Level?

    To continue the evolution of single-use technology (SUT) in biopharma, one area that must be secured is SUT supply chain reliability. Without this, a larger scale adoption of SUT may continue to be delayed as biopharmaceutical manufacturers must have access to a reliable supply chain that allows us to successfully deliver product to our customers.

  9. Single-Use Technology: The Next 5 Challenges To Conquer

    Several challenges to single-use adoption remain. These challenges are serious enough to delay or even stop the use of single-use technology.

  10. Development Of A Two-Column Manufacturing Process For Adenovirus

    Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. Adenovirus vectors are effective tools for the transfer of genetic material into mammalian cells. They offer several advantages, including the capacity to accommodate up to 37 kb of foreign genetic material, very high infection efficiency, ability to infect a wide variety of both dividing and nondividing cell types, lack of integration into the host chromosome, and availability of production systems capable of generating high virus titers.