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  1. All You Need To Know About Contamination Control Strategies, Part 2 5/22/2023

    In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

  2. Optimizing Digitalization To Accelerate Your R&D 5/19/2023

    Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.

  3. Not All Plate Counting Technologies Are The Same 5/18/2023

    While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns. This article shares the advantages of automated colony counters. Keep in mind that not all automated plate counters are the same, though — you'll want to look for important functionality.

  4. All You Need To Know About Contamination Control Strategies, Part 1 5/12/2023

    In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.

  5. Addressing 3 Challenges Of Developing Or Using A New Excipient 5/8/2023

    As the world discovers new molecular entities, new solutions for and innovation of excipients are more critical than ever. However, they are often overlooked. Let’s look at how to address three key challenges: risk aversion, an inconsistent feedback loop between pharma companies and excipient suppliers, and the current lack of regulatory body-backed innovation programs.

  6. 5 Characteristics Of The Automated Microbiology Lab Of The Future 4/24/2023

    The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.

  7. Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems 4/20/2023

    While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.

  8. Protecting Cell And Gene Therapy R&D Against Cyber Threats 4/10/2023

    Depending on the size of the organization, the transparency of its CGT R&D laboratories, and the timeframe for accelerated approval, the concept of building cyber resiliency in these spaces may seem daunting. Nevertheless, there are common first steps taken across the industry that can help support these efforts.

  9. Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny 3/27/2023

    We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.

  10. Best Practices For Cell Culture Media Fingerprinting 3/13/2023

    This three-tier approach to cell culture media fingerprinting helps you to define an alternative method that will allow verification of the quality of the medium as well as fingerprinting. It helps you to choose suitable methods for incoming ID testing based on raw material properties, goals of media characterization, and the resources available.