Guest Columns
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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.
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Frequent Deficiencies In GMP Inspections, Part 1
11/14/2022
It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.
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Assessing Quality Of Viral Vectored Vaccines
11/11/2022
While viral vectored vaccines have been previously developed against Ebola virus, the COVID-19 vaccines were the first widespread global application of this vaccine platform. Adenovirus vectored vaccines have unique critical quality attributes that must be tested to ensure quality and safety.
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The Upper Nasal Space: Drug Delivery’s Next Frontier
11/9/2022
Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits.
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India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
11/7/2022
To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?