Production Featured Articles

  1. Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing 9/8/2021

    Deviations in the pharmaceutical process generally lead to non-compliance and issues meeting demand, so they require careful tracking, monitoring, and remediation. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

  2. How To Find & Manage Biotech Consultants Effectively 9/6/2021

    The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

  3. Designing Agile Manufacturing With An Integrated Drug Substance/Drug Product Ecosystem 9/3/2021

    Companies that want to accelerate their biomanufacturing operations and use their resources efficiently need access to technologies and solutions that can safely and efficiently complete their workflow from idea to injection.

  4. 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?

  5. Choosing The Right CDMO For HPAPI Development, Manufacturing & Packaging 9/2/2021

    Pharmaceutical companies recognize the importance of selecting the right partner for the development, manufacturing, packaging, and commercialization of products containing high-potency active pharmaceutical ingredients (HPAPIs). Experts discussed the key considerations and best practices when outsourcing HPAPI development, manufacturing and packaging to a CDMO.

  6. 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.

  7. 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.

  8. 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).

  9. What Is Process Validation? 8/4/2021

    The goal of process validation is to confirm the process design and demonstrate that the commercial manufacturing process performs as expected.

  10. Raw Materials In Upstream Bioproduction: Challenges And Solutions 7/6/2021

    Media formulations supporting the production of biologics require global sourcing from different suppliers. Here’s how to ensure a reliable raw material supply and to mitigate risk from variability.