Guest Columns
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Novel Approaches For Obtaining High-productivity Clones
1/30/2024
Let's dig into cell line selection approaches, transposons to increase copy number for the gene of interest, and targeted integration to rapidly obtain high-productivity clones.
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Relational Risk Analysis For The Bio/Pharma Industry
1/29/2024
Successfully developing and manufacturing biopharmaceuticals depends on identifying, analyzing, and managing a wide variety of risks. This article presents a novel alternative risk analysis approach that provides a simple, easy, and effective method for quickly and efficiently modeling and analyzing any risk.
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A New Year’s Resolution Suggestion For The FDA
1/22/2024
Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.
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Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3
12/20/2023
This is the third article in a series of three articles. It continues the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.
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WHO’s 6 Principles For An AI Regulatory Framework For Medical Product Development
12/14/2023
In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.
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Mapping The Biosimilar Regulatory Landscape In The Middle East
12/13/2023
Countries in the Middle East and North Africa are promising markets for biosimilar drugs, but inconsistent regulations pose a challenge. Here's an overview of regulatory structures across the region.
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Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement
12/12/2023
The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.
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A Brief Introduction To Environmental Monitoring For Startups
11/17/2023
Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.
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Modular And Single-use Tech Driving The Future Of Biomanufacturing
11/14/2023
BioPlan's 2023 Biopharmaceutical Manufacturing Report shows an increasing demand for single-use and modular manufacturing systems for traditional biologics like mAbs. It also confirms that these technologies become even more critical for advanced therapeutics where small-scale applications may be the only option.
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In Search Of The Unicorn: Do End-To-End C(x)DMOs Really Exist?
11/8/2023
Over the years, we have seen the progression of the biologics contract services go from contract manufacturing organizations (CMO) to what this expert today calls the C(x)DMO: the contract analytical/research/testing development manufacturing organization. Focusing on the mammalian biologics segment, this expert analyzed public information and a proprietary database by looking at 80 service providers supporting projects ranging from early discovery to commercial manufacturing.