Featured Pharma Online Editorial

  1. COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers 10/8/2021

    Just as the U.S. and European bioprocessing supply systems have seen more robust growth than ever before, China’s domestic demands for single-use bags, cell culture media, and purification resins are all on the rise. BioPlan’s Top1000Bio database of global bioprocessing facilities has tracked industry capacity and employment growth over 15 years. 

  2. 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations 9/22/2021

    The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.

  3. Cell And Gene Therapies: Solving Six Challenges 9/20/2021

    This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.

  4. 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations 9/15/2021

    Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

  5. 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.

  6. 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.

  7. 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?

  8. 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.

  9. 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.

  10. 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.