Industry Insights

41. Driving Change of Implementing In-Line Conditioning 2/1/2018

    The large buffer volumes required for biomanufacturing can be a bottleneck, especially when scaling up. Just-in-time buffer preparation can be the solution.

42. How Much Does It Cost To Make A Pharmaceutical Tablet Product? 6/4/2015

    Pharmaceutical companies frequently ask us this question: how much does it cost to manufacture a pharmaceutical tablet? The real answer is: it depends on many factors. We need to truly understand the detailed specifics of the pharmaceutical company’s objectives and requirements for the product, with respect to manufacturing, packaging, testing, and regulatory submission in order for us to address cost in an intelligent and realistic manner.

43. Unpacking FDA’s New Guidance On Collecting Patient Experience Data 7/28/2020

    The FDA recently released one of what is to be four new guidances providing a general overview of patient-focused drug development. This article summarizes each component of "Guidance 1: Collecting Comprehensive and Representative Input" and details how the guidance may impact sponsors of clinical trials.

44. What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks 6/12/2020

    This article describes how the basic principles of managing personal risks of being infected by a respiratory virus can be used to manage risks for developing and manufacturing pharmaceuticals. The goal is to elucidate the basic principles of understanding, managing, and communicating a wide variety of risks from the trivially simple to the very complex.

45. A Better Approach To Biopharmaceutical Water Testing 11/5/2018

    Bioburden and endotoxin testing traditionally have been performed retrospectively, and only through sufficient validation and historical data is sufficient confidence developed. Online water bioburden analyzers (OWBAs) have the potential to eliminate sampling and testing errors via reduced manipulations.

46. How To Manage The “Critical Minutiae” In Drug Development 10/24/2018

    In every tech transfer, each transfer point from one step to the next requires some piece of information, some material, some result, some decision, and/or some signed document.

47. The Antidote To Rising R&D Costs: Effective Outsourcing And RPA 4/8/2016

    As pharmaceutical firms work to close the gap between rising R&D costs and profits in an environment of increasing regulatory control and testing, they face the challenge of securing approval and bringing new drugs to market – safely, efficiently and profitably.

48. Conducting An Independent Analysis Of Drug Development Practices 2/2/2016

    Industry research shows that about 90% of all drugs in clinical development will be rejected by the FDA or will fail to reach the final stages of regulatory review for other reasons. Given the FDA’s stringent rules and standards for review of drugs, this failure rate is not completely surprising. But while we tend to associate a development program’s failure with dangerous adverse events or underwhelming efficacy data, analysis of the true risks associated with clinical research yields some surprising conclusions.    

49. New Regulations And Safety Complicate Drug Labeling 7/2/2018

    Multinational pharmaceutical companies have for decades manufactured drugs for global distribution. Nevertheless, the task of labeling is becoming increasingly difficult and time-consuming. 

50. Creating A Culture Of “Quality Beyond Compliance” 1/21/2016

    If your job is to develop and produce medicines to prevent disease and mitigate suffering around the world, quality is the guiding principle of your business model.