Featured Bioprocessing Editorial

  1. ISO 22519: An Unnecessary, Faulty, And Confusing Standard

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

  2. A Due Diligence Checklist For Leasing A Biotech Manufacturing Facility

    The road to successfully acquiring a property for a biotech startup is littered with potholes and barriers. After the operating organization decides that leasing is the most economical approach, the search should focus on the technical merit of the property and the features it offers. This article provides a technical due diligence checklist that the operating organization can use to frame its decision-making process.

  3. Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but whether it is implemented and becomes an effective measure to sustain the biosimilar market is yet to be determined.

  4. FY2018 FDA Drug Inspection Observations And Trends

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  5. Comparing New U.S. & EU Guidances On The Combination Product Approval Process

    The new EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts by each regulatory body to adequately regulate combination products. In Part 2 of this two-part series, we cover the European Union guidelines for combination products and show how the U.S. and the EU diverge.

  6. Facilitating Data Integrity Through Risk-Based Confirmation Of Performance

    We in pharma and biopharma are required to verify or check or double-check an action or event to be sure it was performed and performed correctly. But what do these words really mean? How do they differ in terms of their actual execution?

  7. An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices

    This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

  8. CAR T-Cell Therapies: Current Limitations & Future Opportunities

    Research in the field of CAR T cells has progressed rapidly, and novel technologies to address areas left unaddressed by Kymriah and Yescarta have started streaming into the research arena. This article aims to focus on the barriers to widespread commercial adoption of the currently available CAR T cell therapies and how these weaknesses are presenting opportunities for developers of the next generation of treatments.

  9. Danger Ahead: What Biotech Companies Need To Know About Leasing Space

    One of the most significant moves for a growing biotech or pharmaceutical company — sometimes considered as a graduation step — is the acquisition of property to conduct clinical trials and manufacture commercial products. In the first installment of this two-part series, we will explore what considerations companies need to make before they decide what type of property to pursue.

  10. FDA’s New Population Pharmacokinetics Guidance: What You Need To Know

    The FDA’s Population Pharmacokinetics Guidance for Industry draft aims to increase safety and efficacy for pharmaceutical products. It calls for sponsors of new drug and biologics license applications to apply population PK analysis, which is frequently used to guide drug development and inform recommendations on therapeutic individualization.