Industry Insights

  1. Digitalizing Pharma Control Strategies: A Roadmap 1/24/2025

    Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

  2. Navigating Regulatory Guidelines For Effective Tech Transfer 6/22/2023

    The authors discusses important aspects of tech transfer (the project management plan, gap analysis, risk assessment, and more) and share the notable FDA and WHO guidelines related to each area.

  3. Deploy And Manage Cloud Microservices In GxP Environments 2/10/2023

    How can your company handle the ever-growing number of microservices per client? Explore deploying and managing microservices, swapping out older versions, and how to in customer's in the process.

  4. What is a CDMO? 6/1/2023

    As you bring a new drug product to market, leveraging the expertise and technical capabilities of a CDMO can help reduce costs and streamline processes on the path to commercialization.

  5. High Voltage Leak Detection For Parenteral Drug Container Closure Integrity 2/25/2023

    Medical and pharmaceutical products are often packaged in fluid-filled containers. Learn about CCIT using high voltage leak detection (HVLD), how HVLD technology works, and more.

  6. Key Considerations And Options For Sample Collection In Process Sampling 8/5/2022

    We offer useful insight into methods and collection options for process sampling, as well as how each fit based on assay type and process stage.

  7. Demystifying Blockchain-Supported Smart Contracts 11/15/2021

    Promising increased accuracy, transparency, and security, smart contracts and blockchain technology are the next steps in the evolution of secure data transaction. Companies in the pharmaceutical industry, and their supply chains, will be forced to adapt their operations to keep up with these generational changes in order to competitively deliver services and treatments.

  8. Error Proofing Single-Use Systems: Three Strategies From Med Device 1/4/2022

    Using lessons learned and best practices from the medical device industry, discover demonstrated error-proofing steps to eliminate risk or potential misconnections when designing single-use systems.

  9. An Introduction To Trending In Environmental Monitoring Programs 4/5/2021

    Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM. 

  10. First In Line: FDA Vs. EMA Biopharma Approval Times 1/20/2021

    The majority of biopharma companies place the most emphasis on the U.S. market as the pillar of their business case and commercial strategy, but should they? This article reviews data from more than 200 new therapeutics approved by the FDA over the past five years to determine if there really is a difference in approval timelines between the FDA and EMA.