Guest Columns

61. Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated 8/31/2022

    Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe Carryover (MSC). This article provides the historical development of both terms and why we should replace the MAC/MACO with the MSC.

62. Biotech 2016 To 2022 And A Look Ahead 8/30/2022

    The last five years have been disruptive regardless of sector, yet biotech managed to weather the storm. This article looks at the past five years in the industry from a macro view and shares what biotech executives should consider in the months ahead.

63. Attributable Data Integrity in Modern Biopharma Using ALCOA Principles 8/29/2022

    This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.

64. How The Right CDMO Partner Can Accelerate Biologics Development 8/25/2022

    The manufacturing lag in developing innovative biological drug therapeutics has created a bottleneck, so the industry needs better streamlining. That's where establishing a strategic partnership with the right CDMO partner can step in to accelerate your development and manufacturing timeline.

65. A CTO’s Journey Into Continuous Biomanufacturing 8/24/2022

    At a recent Evaluating BioPharma virtual event, moderator John Bonham-Carter asked Chris Hwang, chief technology officer at Transcenta Holding Ltd., about Chris’ journey and experiences with continuous bioprocessing thus far in his career.

66. The Environmental Impact Of Biopharma Continuous Manufacturing: Part II 8/22/2022

    Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.

67. How To Avoid Form 483s For Biopharma Software Validation Failures 8/17/2022

    The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.

68. The Process Map To Ensure Biopharma Raw Materials Supply 8/16/2022

    In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.

69. FDA Seeks Comment On Conducting Remote Regulatory Assessments 8/11/2022

    The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

70. Tools & Techniques For Biopharma Root Cause Analysis 8/10/2022

    In biopharma, we must provide a complete and thorough record of our thought processes in order to allow a third party to understand how we have arrived at the root cause of a given problem. This article follows a mock case study to demonstrate a progression of tools and techniques to use.