CMOs Expand Biologics Manufacturing - Pharmaceutical Technology

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CMOs Expand Biologics Manufacturing
A surge in capacity in contract microbial and mammalian cell-culture is underway to meet rising production needs for biopharmaceuticals.


Pharmaceutical Technology


Carragher and CEO Clinton Potter, associate professors at The Scripps Research Institute in San Diego, founded NanoImaging Services with support from FEI Company (Hillsboro, OR), a manufacturer of TEMs and other nanotechnology tools.

TEM can be applied to various samples, which include proteins, protein complexes, viruses, virus-like particles, biological vaccines, lipid vesicles, and cell-free lysates.

The company worked on the characterization project for "Gardasil," Merck & Co.'s (Whitehouse Station, NJ) vaccine against certain types of the human papillomavirus Using cyro TEM, Potter and Carragher developed advances in specimen preparation, microscope control and automation, and data tracking.

NanoImaging offers services from visual inspection and statistical characterization to three-dimensional reconstruction and antibody/labeling experiments, using TEM procedures that range from conventional negative staining to advanced cryo techniques with automated image acquisition and analysis, according to company information. In the most advanced applications, samples in physiologic solution are instantly frozen in vitreous ice to preserve biological structures in their native hydrated state. Thousands of images, automatically acquired with low-dose techniques, are sorted and averaged together to create high-contrast, high-resolution (approaching 1 nm), low-noise images, and statistically valid sampling. A secure web-based interface allows images to be viewed remotely and direct experiments remotely, in real time. Results, along with all meta data, are stored in a relational database.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ, 08830, tel. 732.346.3072,

References

1. W. Downey and L. Sopchak, "Evaluating Supply and Demand Patterns for Contract Biologics Manufacturing," Pharm. Technol. 31 "Outsourcing Resources Suppl.," 24–32 (2007).


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