GUEST COLUMNISTS

  • Merck’s 2 Lessons Learned In Overcoming Single-Use Materials Supply Challenges

    The COVID-19 pandemic has caused severe disruption to supply chains, making it difficult to get material. At Merck, a situation occurred recently wherein they were unable to get the filter assembly they needed, and their supplier was struggling to meet demand. This article shares Merck's two lessons learned from the experience.

  • Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon

    This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.

  • Congressional Bill Supports Biopharma Advanced & Continuous Manufacturing

    The House recently passed H.R. 4369, which authorizes $100 million over four years to establish National Centers of Excellence in Advanced and Continuous Manufacturing at U.S. academic institutions. This article delves into the news and how it fits into other U.S. initiatives supporting the field.

  • EPCIS Implementation: 4 Takeaways, Next Steps For DSCSA Compliance

    With the Nov. 27, 2023, DSCSA deadline quickly approaching, the HDA Research Foundation recently released a survey to assess how the industry is preparing. This article summarizes the 4 key takeaways as well as your next steps for DSCSA compliance.

  • Method-of-Treatment Patents: Increasing Value & Risk

    Patents on methods-of-treatment using pharmaceuticals are being asserted in broad ways against a variety of parties, with potential liabilities of hundreds of millions of dollars. Method patents can be obtained not only for new indications but also for other discoveries made after the initial approval, like dosing regimens. 

  • How AstraZeneca Optimized Vapor Phase Hydrogen Peroxide Gassing Cycle Development

    Demonstration of efficacious decontamination is a critical aspect of aseptic processing and sterility testing. By adopting enzyme indicators in the cycle development phases, greater understanding of efficacy of the gassing process can be achieved by providing quantitative results in a faster time frame. Here's how AstraZeneca did it.

  • The Data Integrity Body of Knowledge Expands with New & Pending Guidances

    Some of the contemporary guidance documents for data integrity in biopharmaceuticals and medical devices, both released and in draft, are explained here to better understand their scope and relationship to one another and to provide an example of the ever-changing landscape of data integrity challenges and potential solutions.

  • The EU’s Biopharma Industry Can Deliver More With IDMP Data Standards

    Promises abound in the IDMP software industry about the vast transformation potential of data-driven processes beyond pharma regulatory exchange. Biotechs, unencumbered by legacy systems and processes, could blaze a trail. This article provides the steps to take now.

PHARMA ONLINE WHITE PAPERS

  • Top 8 Obstacles In Pharma & Biologics Products Registration & Submission Management

    Life science organizations can’t afford any delays in product registrations and overall time to market. As with many industries, time is money. There are a variety of obstacles that result in delays to registrations, many of which can be avoided using sound business processes and leveraging technology to automate processes. Here we identify some of the most common problems below and share some insights on how best to address them.

  • Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions
    4/13/2021

    During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand.

  • Developing TIL Therapies: Sample Collection And Processing
    7/16/2020

    While it has been advanced over many years, the process of developing TIL therapies still suffers from certain challenges. This article attempts to lay bare some of these challenges and discuss how novel technological solutions can help overcome them.

  • How Buffer pH And NaCl Affect Size Exclusion Chromatography
    4/22/2020

    Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.

  • Managing The Expectations Of Auditors For Microbial Data Collection
    5/4/2021

    Microbial environmental monitoring is a growing challenge for the pharmaceutical industry in an increasingly digitized industry, otherwise known as Industry 4.0. Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.

  • Bringing The Freezing Of Biopharmaceuticals In From The Cold
    3/18/2021

    In this paper, we review end-to-end freezing solutions that integrate bulk filling, storage, shipping, thawing, and fill-finish operations to minimize risk and preserve product quality.

PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

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Our latest e-book explores efforts to pay closer attention to how your company’s culture and operations ensure the completeness, consistency, and accuracy of data - AKA data integrity. Such data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), according to the FDA. Similarly, data must be complete, consistent, and accurate throughout the data life cycle, according to the MHRA and the Pharmaceutical Inspection Co-operation Scheme.

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LIFE SCIENCE CONNECT SPOTLIGHT JOB OPENING: TARSUS

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Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.

Sound interesting?

Read the Job Posting to learn more.

TRAINING COURSES