Industry Insights

  1. Solving The OOS Problem With Continuous Manufacturing
    8/13/2017

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.

  2. Designing A Biomanufacturing Facility Incorporating Single-Use Technologies
    12/5/2016

    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?

  3. Are You Ready For The Future of Biomanufacturing?
    1/19/2018

    As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way. 

  4. Accelerate Biopharmaceutical Development With Novel Analytical Techniques
    4/28/2017

    This article explains how using an Octet-based Fc receptor panel may help developers achieve a faster assessment of monoclonal antibody functionality, well before the final molecule is selected.

  5. Capitalize On Your Merger/Acquisition: 4 Tips To Consolidate Your CMO Network
    4/27/2017

    Complex CMO networks are expensive and require many resources to manage. Plus, they prevent purchasing and operating at scale. Yet, the process of consolidating CMOs is daunting.

  6. Route Scouting In API Development: A Luxury Or Necessity?
    3/29/2017

    Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Most of the brightest chemists chose to spend their time “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to critical aspects of scale-up like safety, waste management, or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines) far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst-performing sectors in terms of waste produced per unit of product made. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus a new field of chemistry called process research was born.

  7. What You Need To Know To Avoid Costly Delays In Your API Scale-Up
    8/22/2017

    If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy. 

  8. Let The Molecule Decide
    11/2/2017

    Formulation techniques and technologies can easily become more habit than science, but a single technology does not work for all compounds. Each new drug is unique and deserves a fresh approach to formulation.

  9. Prepare For An FDA Bioburden Inspection
    1/29/2018

    Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips on how to best approach a bioburden problem when an FDA inspection is imminent.

  10. How To Live With Uncertain Pharma Demand Forecasts
    6/10/2016

    The consequences of inaccurate demand forecasting can be reputational damage, market share loss, lost days of production, destruction of inventory, and layoffs.