GRAS Screen™ 7 and 8 were developed by Hampton Research for the crystallization of proteins, including monoclonal antibodies.
Each of the chemicals in GRAS Screen 7 and 8 has been used under one or more of the following categories. As (1) a Generally Recognized As Safe (GRAS) substance, (2) a pharmaceutical excipient, (3) a normal physiological constituent, (4) a metabolic byproduct, and/or (5) a Everything Added to Food in the United States (EAFUS) substance.
GRAS Screen 7 samples 9 salts (Ammonium-acetate, chloride, citrate, formate, phosphate, sulfate, tartrate, Potassium phosphate, & Sodium acetate) at 4 concentrations, sampling 8 unique buffers (pH 4.5 to 10.0) as well as 8 buffer controls without salt. GRAS Screen 7 is supplied in a 96 Deep Well block format and is compatible with robotic and multi-channel pipet liquid handling systems. GRAS Screen 7 is compatible with vapor diffusion, free interface diffusion, and microbatch crystallization methods. For research use only.
GRAS Screen 8 samples 5 salts (Sodium - chloride, citrate, formate, phosphate & tartrate) at 4 concentrations, sampling 8 unique buffers (pH 4.5 to 10.0). GRAS Screen 8 is supplied in a 96 Deep Well block format and is compatible with robotic and multi-channel pipet liquid handling systems. GRAS Screen 8 is compatible with vapor diffusion, free interface diffusion, and microbatch crystallization methods. For research use only.
1 ml, Deep Well block format
1 ml, Deep Well block format
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4. Fast and Scalable Purification of a Therapeutic Full-Length Antibody Based on Process Crystallization. Dariusch Hekmat et al, Biotechnology and Bioengineering, Vol. 110, No. 9, September, 2013.
5. Towards Protein Crystallization as a Process Step in Downstream Processing of Therapeutic Antibodies: Screening and Optimization at Microbatch Scale. Yuguo Zang et al, PLoS One. 2011; 6(9): e25282.
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8. Using X-Ray Crystallography to Simplify and Accelerate Biologics Drug Development. Brader ML, Baker EN, Dunn MF, Laue TM, Carpenter JF. J Pharm Sci. 2017 Feb;106(2):477-494. doi: 10.1016/j.xphs.2016.10.017.
9. Excipients and Their Role in Approved Injectable Products: Current Usage and Future Directions. Sandeep Nema and Ronald J. Brendell, PDA J Pharm Sci and Tech 2011, 65 287-332.