Accelerated FDA Review Through Syft’s Advanced Manufacturing Technology

6 months ago

In December 2023, the FDA issued guidance to manufacturers of small molecule or biological products that the use of Advanced Manufacturing Technology (AMT) can accelerate the review of their NDAs, BLAs, and ANDAs through prioritized interaction.  The use of AMTs in drug manufacturing has the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products.  In addition, drugs manufactured with AMT designation have a higher probability of expedited access to the market. 

The FDA describes methods of manufacturing that are eligible for AMT designation as those that incorporate a novel technology or uses an established technique or technology in a novel way that will substantially improve the manufacturing process for a drug while maintaining equivalent, or providing superior, drug quality, including by:    

  • Reducing development time for a drug using the designated manufacturing method; or
  • Increasing or maintaining the supply of a drug that is life-supporting, life-sustaining, or of critical importance to providing health care, or a drug that is on the drug shortage list under section 506E of the FD&C Act (21 U.S.C. 356e).

SIFT-MS is a novel technology that can be used to reduce development time by speeding up time to data.  It can also be used to increase drug quality through the identification of contaminants missed by traditional chromatographic approaches.  Sitewide solvent consumption can be reduced by utilizing this green technology that requires no chromatography, solvents, or consumables.  SIFT-MS is an ideal solution for in-process QA / QC and online manufacturing workflows.  

SIFT-MS provides real-time analysis of trace volatile compounds that traditionally require intensive sample preparation and complex chromatographic separation methodologies.  Problematic drug impurities like nitrosamines, ethylene oxide, residual solvents, formaldehyde, and benzene can be analyzed using the same system without the need for column changeover or other chromatographic delays.  Furthermore, difficult applications like ethylene oxide characterization which struggle to overcome the sample prep bottleneck are streamlined by this novel technology.  SIFT-MS is designed for simplicity and can be scaled to every phase of drug manufacture where quality checks are required.  It has also been shown to provide more accurate contaminant data than GC-based methods.   

SIFT-MS is an ideal alternative to slow, off-line analysis methods when implementing a continuous manufacturing process.  This real-time technique provides high-quality, quantitative data to applications such as bioreactor headspace monitoring, hot-melt extrusion processes, and 3D printing.  Case studies showcasing the application of SIFT-MS in continuous manufacturing are presented in this webinar presented by Element Lab Solutions and CMAC Future Manufacturing Research Hub.       

Syft Tracer Pharm11 is a complete analytical solution designed for high-throughput, 21 CFR Part 11 compliant environments.  It enables the analysis of >200 samples daily with full user and data traceability.  Previous studies have demonstrated its ability to analyze in nine hours would take five chromatographic systems 24 hours to complete.  It is estimated that sample capacity can be increased by 72% and cost efficiency improved by 97% in a similar use case.   

Syft Technologies understands how important it is to get life-saving drugs to market faster and the business impact that it can have for manufacturers.  We are confident that SIFT-MS aligns with the intent of the Advanced Manufacturing Technology initiative.  Contact us to discuss how we can assist in meeting your commercialization objectives.