Guest Columns
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5 Steps To Eliminate Weak Links In Your Data Governance
12/2/2022
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
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Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
12/1/2022
This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
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Modularity And Mobility Hold The Keys To Surge Manufacturing
11/30/2022
When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.
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Create The Correct Checklist To Land The Best CDMO
11/29/2022
When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for best oversight of your supplier.
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The Fruits Of Synthetic Biology
11/22/2022
Can cell and gene therapies be programmed with sophisticated behaviors, to sense, make decisions, and treat important diseases effectively? Synthetic gene circuits may hold the key.
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A Methodology To Support Particle Investigations In Biopharma Products
11/22/2022
Particles in parenteral products are a major cause of product recalls, and appropriate management of risk from visible particles is vital. This standardized methodology provides users with a decision-making tool to clarify the risks presented by a particle to a batch.
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1 Year Out, Where Do We Stand On DSCSA Implementation?
11/21/2022
This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.
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FDA Releases Guidance On Drug Products Containing Nanomaterials
11/18/2022
In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.
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The Expanding Patent Landscape For RNA-Based Therapeutics
11/16/2022
The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
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Biology Meets Computer Science For Next-Gen Biologics Drug Discovery
11/15/2022
We have entered a new age in biologics development, which is undergoing a technological revolution with an increasing focus on software-dependent and data-driven results. Integrating the biological and the computational creates a need for specialists working together in parallel.