• No, Biologics Are Not Natural Monopolies

    Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.

  • Are You Approaching LIMS Validation Correctly?

    Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.

  • Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs

    The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits. 

  • An Analysis Of The Gene Therapy Viral Vector Landscape

    Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.

  • Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm

    Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.

  • Making Sense Of Antibody Epitope Claims

    Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent. 

  • How to Ensure Your Quality Culture Assures Data Integrity

    One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.

  • Tools And Best Practices For Trending Environmental Monitoring Data

    Environmental monitoring (EM) trending is an essential component of the EM program to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure establishment of an efficient environmental monitoring program.


  • Telltale Signs You’re With The Wrong CDMO

    Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

  • Accelerate Process Intensification For Viral Vaccine Manufacturing

    This article details an integrated portfolio of technologies to facilitate process intensification of viral-based vaccines including SARS-CoV-2 vaccine candidates.

  • Test Method Development For A Container Closure Integrity Test Using Headspace Gas Ingress

    To ensure patient safety, good container closure integrity (CCI) is of great importance for all sterile injectable products. Recent regulatory guidance has made clear that there is no ‘gold standard’ for CCI testing. As a CCI test method, headspace analysis is based on detecting changes in the headspace gas composition that result from gas ingress through a leak. Non-destructive headspace analysis, using laser-based spectroscopy, can be used to directly quantify the gas concentration inside a sealed parenteral package. It can be applied to a range of product configurations, and formulations, and has historically been used for detecting leak defects in modified headspace product.

  • Is Your Complex Formulation Process Set Up For Success?

    When pursuing a drug delivery system that involves a complex formulation, you must be prepared for the requirements to achieve successful scale-up and manufacturing. Discover six major types of complex formulations as well as the necessary equipment and processes to develop GMP-compliant formulation.

  • Evolving Containment In Pharma Manufacturing Facilities

    Pharmaceutical manufacturing is now undergoing significant transformation. COVID-19 and its pressure on nearly every aspect of human life has put a gigantic emphasis on rapid development of prescriptives, vaccines, and accelerated means for pharmaceutical mass-production. This paper characterizes the new production directions in pharmacy and describes flexible equipment to improve pharma efficiency, purity, and production safety in the coming decade.




 In this roundtable Q&A, industry experts from AstraZeneca, Takeda, Biogen, and NSF Health Sciences share insights on important topics related to human performance in pharmaceutical operations — offering insight into how forward-thinking organizations treat “human error” in the workplace.

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