Development of the ideal DNA vaccine requires the optimization of delivery strategies and plasmid vectors.
Quality/GMPs
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Digitalization of QbD Risk Assessments
The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
Subjectivity in Quality Risk Management
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Phase-appropriate Compliance for Cell and Gene Therapies
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
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An in-depth characterization of maize-derived trypsin revealed an unusual nonconsensus N-linked glycosylation.
Manufacturers fund research and reduce prices to tackle diseases around the world.
Inside the National Institutes of Health
Developing a quality agreement template for single-use systems.
Market considerations and new technologies must be recognized to achieve the full benefits of manufacturing prefilled syringes.
An interview with Oskar Gold, vice-president, key account management and corporate marketing, at Vetter.
The lower price of biosimilars will increase patient access to medicines and spur innovation.
The market landscape for biosimilars is in flux, with limited penetration now, but with the potential for growth for those who can navigate the market. Plus: A SWOT analysis of biosimilars by Anjan Selz.
PDUFA renewal legislation sets stage for new policies affecting revenue, research, and oversight.
Why SOPs are rarely followed, often cited, and in great need of follow-through.
A report commissioned by FDA evaluates the QbD paradigm.
The author describes techniques that can be used to provide the analytical data required by ICH Q6B for characterization of monoclonal antibodies.
Overcoming limitations of volumetric techniques and detecting transparent particles.
US Pharmacopeia promotes horizontal standards and a product-class approach for quality attributes.
Rising imports, overseas production spur collaboration and realignment of enforcement activities.
The authors re-examine environmental controls in the context of technical advances in manufacturing.
Industry may be its own obstacle to success in achieving the desired high-performance state.
Incorporating regulatory requirements into the product life cycle is crucial.
Follow-on versions of complex biologics require extensive expertise.
BIO's president and CEO provides insight leading up to the 2011 convention.
The authors focus on operational excellence in manufacturing of biotechnology therapeutic products in the QbD paradigm.
Industry struggles to curb drug abuse, diversion, and disruptions in supply to ensure access to quality products.
Clear documentation and open communication are essential for effective technology transfer.
An overview of applications in the analysis of nutrients and metabolites.
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