Guest Columns
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Making Sense Of Antibody Epitope Claims
4/16/2021
Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.
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How to Ensure Your Quality Culture Assures Data Integrity
4/14/2021
One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.
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Tools And Best Practices For Trending Environmental Monitoring Data
4/11/2021
Environmental monitoring (EM) trending is an essential component of the EM program and can be used to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure that an efficient environmental monitoring program is established.
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Biopharma Cold Chain Logistics 101
4/9/2021
Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.
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Why Adjusted Risk Likelihood Should Displace The Risk Priority Number
4/7/2021
While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.
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An Introduction To Trending In Environmental Monitoring Programs
4/5/2021
Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM.
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FDA Inspections: Are Changes On The Horizon?
4/2/2021
A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.
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Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across
3/31/2021
Biosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.
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Life Sciences Dealmaking Aims At Early Stages Amid COVID-19
3/29/2021
Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets.This article highlights takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook, which tallied 1,138 acquisitions, licensing, and R&D deals in 2020.
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Complying With Batch Release: Auditing Electronic Batch Records
3/26/2021
This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation.