Contributing Editors

  1. What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively? 9/3/2021

    When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

  2. 3 Successful Strategies For Protecting Your New Biopharma’s IP 9/1/2021

    Intellectual property is the lifeblood of new biopharma entities. Patent protection is necessary to secure investment, to build a solid foundation with opportunity for future growth, and to establish viability within a highly competitive landscape. This article addresses key patent-related considerations for startups and small or early-stage players in the life sciences arena.

  3. How To Advance Continuous Bioprocessing Using Continuous Countercurrent Tangential Chromatography 8/30/2021

    Continuous countercurrent tangential chromatography (CCTC) addresses the inherent limitations of column-based systems by conducting the chromatographic operations (binding, washing, elution, stripping, and regeneration) on a flowing slurry, with inline static mixers used to ensure good contacting between the resin slurry and the clarified cell culture fluid/required buffers.

  4. Best Practices For Raw Material Supplier Change Notifications: New BioPhorum Guidance 8/27/2021

    Managing the large volume of supplier change notifications while safeguarding the continuity and compliance of a complex and tightly regulated supply chain is a resource-intensive task. To address the challenges, the BioPhorum Raw Material Variability Workstream has developed a guidance document designed to streamline the process without straying from essential and strict risk mitigation procedures.

  5. Cell & Gene Therapy Financing: What Is The Role For Private Equity And SPACS? 8/26/2021

    This article explains how SPACs help cell and gene companies go public with some advantages.

  6. Best Practices To Ensure Quality Of Raw Materials Used To Manufacture Therapeutic Proteins 8/25/2021

    Across biologics, raw material quality is a key driver of product quality and consistency. This article recaps a recent U.S. Pharmacopeia (USP) workshop on the subject, including recaps of best practices and experiences shared by the FDA, Merck, Biogen, and more.

  7. An Analysis Of ICH Draft Guidance Q13: Continuous Manufacturing Of Drug Substance And Drug Products 8/23/2021

    The International Council for Harmonisation (ICH) published a draft version of ICH Q13, Continuous Manufacturing of Drug Substances and Drug Products, for public commentary on July 27, 2021, with the aim of harmonizing the regulatory and quality perspectives of ICH members, including the FDA (U.S.), EMA (EC), and PMDA (Japan).

  8. On the Path to Accessible Cell Therapies: Overcoming Current Challenges 8/23/2021

    Control must be maintained throughout all aspects of the supply chain, beginning with manufacturing all the way through to the administration of the product to the patient.

  9. The 5-Step Checklist For A More Mature, Robust Quality Management System 8/20/2021

    Whether you are preparing for a pre-approval inspection, have the corporate desire for continuous inspection readiness, or are engaged in a LEAN initiative to clean up and strengthen your quality management system (QMS), further maturing your QMS can be helpful to ensuring a robust, comprehensive, and compliant QMS.

  10. Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity 8/18/2021

    The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.