Industry Insights

  1. The Rising Cost of Helium May Be Straining Your Budget

    A number of industries rely on leak detection equipment and other leak testing services to ensure their products are safe and effective for consumer use: radiators, for example, are subject to a very tight leak specification to ensure that the product does not leak coolant.

  2. Is Helium Leak Testing Worth The Cost?

    When it comes to meeting quality measures, manufacturers have a variety of standards from the ASTM, FDA and other organizations that they must meet.

  3. USP <1207> Updates Leak Testing Recommendations for Pharmaceutical Companies

    Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.

  4. How To Increase Regulatory Flexibility And Tablet Production Efficiency

    The goal of every pharmaceutical developer is to create quality products that generate consumer satisfaction, require low cost, and have low risk.

  5. What’s Next For Single-Use Technology In Bioprocessing

    The advantages of single-use are well-known — faster, smaller, greener, cheaper, and safer — and increasing numbers of biomanufacturers have sought to reap these benefits, especially as patent expiration and increasingly globalized manufacturing continues to change the dynamics of biomanufacturing.

  6. 3 Steps To Prepare For FDA’s Final Quality Metrics Guidance

    Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals.

  7. Quality Metrics: How To Add Value And Meet The FDA’s Expectations

    Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. However, the task of selecting the right metrics to incorporate has always been a bit of a challenge as quality can be subjective and hard to measure in a meaningful way. 

  8. CDMOs — At The Core Of Next-Generation Pharma Models

    In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.


  9. Keys To Formulation Development Is In The Details

    Developing a robust tablet formulation that can be scaled into manufacturing without any issues can be a challenge. 

  10. Digitally Transforming Laboratory Operations

    “Digital transformation” is a common buzzword across industries today, but is it more than just jargon?  Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.