10.31.21 -- Is The FDA About To Reclassify Your Drug Product As A Device?
 
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Featured Editorial
Is The FDA About To Reclassify Your Drug Product As A Device?
 
By Kayla Cristales, Randy Peak, and Suzie Trigg, Haynes Boone

Until October 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.
Is A SPAC The Right Option For Your Emerging Biotech?
 
By Alex Zuluaga and Arda Ural, Ernst & Young

As biotech and emerging pharma companies weigh their options for raising capital, the popularity of the special purpose acquisition company (SPAC) has surged, with a 175% increase in announced SPAC M&As seen between 2019 and 2020. This article examines the considerations you should make when weighing if a SPAC is the right option for your company.
Industry Insights
Is Your Biologics At Risk For Protein Aggregation? Part 3
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne

The main culprit of a failing biologics drug is usually a flawed formulation. In this article, we cover formulation components and how they may affect protein aggregation. Part three of a three-part series.
Enabling Biologics Drug Delivery Of Volumes Beyond 1 mL With Ergonomic Injection Solutions For Targeted User Populations
Poster | By T. Chevolleau, N. Montemuino, and M. Lan, BD Medical - Pharmaceutical Systems

Self-injection delivery formats are evolving beyond the 1 mL barrier to meet the emerging needs of biologics drug formulations while simultaneously serving patients by maintaining safety and ease of use. Injection volumes that are &GT 1 mL can be feasible for patients to inject manually provided that the delivery system design is easy to use, intuitive, and comfortable to hold and inject.
Enhanced Host Cell Protein Analysis In Biologics Manufacturing
Article | Cytiva

iEnzyme-linked immunosorbent assays (ELISAs) to monitor host cell protein levels are challenging. This article illustrates an enhanced anti-host cell protein antibody coverage analysis method solution.
Does Selecting A CDMO Based On Contract Price Really Save You Money?
Article | Pfizer CentreOne

Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.
ISR's Contract Manufacturing Databook
e-book | ISR Reports

It can be difficult to find industry-specific, easy-to-interpret, trustworthy market data. This ISR Reports e-book is chock full of free drug development and manufacturing facts, figures, and expert perspectives.
Cell Line Development Toolbox For Intensified Bioprocessing
Webinar | Sartorius

If intensified processes lead to productivity improvements, then the Cell Line Development Toolbox holds the answers to make intensified bioprocessing a reality. Learn more about these technologies to optimize clone selection, shorten seed trains, and speed up early process development.
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Large Molecule Biologics Made With Intelligent Collaboration
Pfizer CentreOne
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