Liquid Dose Featured Articles

  1. FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs 5/4/2023

    In April 2023, the FDA issued an updated guidance superseding and replacing the previous 2020 document about managing drug shortages and explaining what was expected of industry and how the agency was going to manage the shortfalls. This article summarizes the guidance in a helpful FAQ format.

  2. India's CROs & CDMOs Come Of Age In The Global Marketplace 5/4/2023

    Most of the top 10 pharmaceutical companies and many large biotech companies today get a portion of their preclinical/clinical research, drug development, and/or manufacturing done in India. While a low price is the initial attraction, there are additional factors that can be more meaningful.

  3. 5 Emerging Trends In Complex Small Molecule Drug Production 5/3/2023

    The small molecule landscape is changing in terms of drug product complexity, molecule potency, manufacturing trends, and industry makeup. How the industry responds will shape the next chapter of small molecule drug development.

  4. 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.

  5. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

  6. Stability Chambers: Testing, Equipment, And Uses 3/7/2023

    Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.

  7. Lyophilization Contract Manufacturing Services: What To Know 3/7/2023

    Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.

  8. Meeting The Growing Demand For Pre-Filled Syringes 3/7/2023

    The market for pre-filled syringes is growing rapidly. Learn more about the benefits for consumers, providers, and manufacturers, and the importance of partnering with a reliable fill finish facility.

  9. Why It Is Never Too Early To Consider Tungsten Interactions 3/2/2023

    A key challenge to sensitive biotechnological or biologic drugs, especially proteins, is the potential presence of tungsten and tungsten oxides from the syringe forming process.

  10. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.