Featured Bioprocessing Editorial

61. The EU Qualified Person (QP) Demystified 10/29/2019

    For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons may be perceived as a challenge to overcome, because their role and responsibilities are not fully understood.

62. Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes 10/29/2019

    Once again, Congress has its eyes on the pharmaceutical industry. Legislators from both parties have been active in proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.

63. Are Good Manufacturing Practices No Longer Good Enough? 10/28/2019

    Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?

64. Can Regulatory And Pharmacopeial Compliance Practices Establish Quality? 10/25/2019

    The stated mandate of regulatory authorities (e.g. the FDA) and pharmacopeias (e.g. USP) is to establish and monitor safety, efficacy, and quality of manufactured drug products. This article examines the role of those authorities on quality during production processes.

65. FDA FY2018 Human Tissue And Cell Therapy Observations And Trends 10/24/2019

    This article presents the most recent publication of GMP Human Tissue for Transplantation Form 483 observation data from the FDA. We examine data from FY2018 and evaluate a total of four years’ worth of trends in GMP inspection enforcement in this area.

66. 5 Essential Factors For A Successful Biopharma Product Launch 10/23/2019

    Rapid changes in the biopharma industry—including novel treatment modalities (i.e. gene and cell therapy); increased use of biomarkers; rare diseases that are hard to identify, diagnose, and access; and expanded requirements to demonstrate economic value—make new product launches increasingly difficult.  

67. Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time 10/22/2019

    In this second part of a two-part series, we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.

68. An Introduction To Sampling Plans 10/21/2019

    Sampling plans are used extensively throughout organizations regulated by the FDA. Most have a statistical procedure that specifies a certain acceptable quality level based on risk. (If not, they should!) However, most  follow the requirements of the procedure without fully comprehending how sampling plans actually work. This is why you should.

69. Trends To Watch In China’s Biopharma Industry 10/18/2019

    China’s biopharma segment has experienced double-digit growth for the past decade, and the landscape is poised for robust growth for the near future. The country's biopharma sales are on track to reach over $50 billion. Here's why that matters to you.

70. How Pharma Manufacturers Must Prepare For EU MDR And IVDR 10/16/2019

    Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU MDR and EU IVDR will effect their products. No medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.