Featured Bioprocessing Editorial

51. Pigeons In The Plant: 10 Real-Life Pharma Facility Blunders (And How To Avoid Them) 11/13/2019

    There are situations we have come across where we really scratch our heads and say, “What did they just do, and what were they thinking?” This article describes a series of events and activities that we have seen that are at once amusing, baffling, and revealing of the flaws in our industry.

52. EU5 Biosimilar Adoption: What Can The Past Tell Us About The Future? 11/12/2019

    In this article, we review the penetration of biosimilars in the top five EU markets, with special emphasis on the years 2016 and 2018, as well as the key elements that could explain these results. The survey focuses on 23 of the 57 approved products for which we have data from at least 18 months in the five markets.

53. SOP Remediation: When Reinventing The Wheel Is The Best Approach 11/12/2019

    When faced with scenarios that demand SOP remediation (outsourcing, mergers, acquisition), repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when you factor in time, human resources, and long-term outcomes.

54. What Can We Learn From Compounding Pharmacies Producing Small Parenteral Batches? 11/11/2019

    Does the pharmaceutical industry want to sit on the sidelines while its products are being manipulated and modified — a danger? Or will the industry provide its products in a manner or with the tools that will enable compounding pharmacies to succeed in delivering a safe and effective drug to the patient — an opportunity?

55. 4 Tips For Successful Collaboration With Your EU Qualified Person 11/8/2019

    Engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated challenges.

56. Debunking The Top 3 Myths About Quality By Design (QbD) 11/8/2019

    Pharmaceutical QbD and quality risk management principles have become mainstays, but prevalent myths stymie adoption of the concepts. Dismantling those myths enables more companies to capitalize on the benefits of QbD.

57. Will Authorized Biologics Disrupt The Market For Biosimilars? 11/5/2019

    The small molecule generic drug market and the current biologics/biosimilar market are ultimately not directly comparable. However, it's instructive to analyze how authorized generics impact the small molecule space to predict how authorized biologics may impact the biosimilar/interchangeable market in the future.

58. Closing Quality Gaps: 7 Steps To Properly Resource A Remediation Project 11/4/2019

    Teams often rely on ad hoc resource allocation and a naively hopeful attitude about the qualifications and capabilities of project team members. These tips can help you avoid such mistakes and improve the chances of your project's success.

59. Achieving Integrated Quality Through A Continued Process Verification Program 11/1/2019

    Continued process verification (CPV) is not only required for companies but also is a good investment in product quality and setting the foundation for continuous improvement. 

60. Understanding The FDA’s KASA Framework 10/30/2019

    The FDA's Knowledge-Aided Assessment & Structured Application Framework marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed.