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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.
MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.
Through a Cooperative Research and Development Agreement (CRADA), the US Department of Commerce measurement science agency, The National Institute of Standards (NIST), and biologics research arm of AstraZeneca, MedImmune, announced they will collaborate to study proteins in biopharmaceuticals and the mechanisms through which these types of drugs work. The partnership will focus on engineering and formulation, with a special concentration on the optimization of fill/finish operations of biologics to minimize subvisible particles. Ultimately, both groups seek to better understand protein folding at a molecular level through the development of new measurement tools.
The use of a CRADA will allow NIST, a federal laboratory, to exchange resources with MedImmune, a private company, to “advance technologies that can then be commercialized for the benefit of the public and the US economy,” according to a press release announcing the partnership. MedImmune will fund seven postdoctoral students from NIST to conduct the drug development research and will also provide the agency with access to its portfolio of monoclonal antibodies and other proprietary materials. The research will be conducted in both NIST and MedImmune labs in Gaithersburg, Maryland, and will be led by Dr. Jai Pathak (formulation sciences department, MedImmune), Dr. Steven Hudson (polymers and complex fluids group, NIST), and Dr. Joseph Curtis (NIST Center for Neutron Research).
With MedImmune’s funding, NIST will work on developing a new, sensitive form of Raman spectroscopy to characterize the protein types and quantities within a sample. This will inform researchers of whether or not the proteins in a sample are properly folded and are interacting with other molecules as intended, and will also guide understanding about protein misfolding. The use of the spectroscopy and neutron scattering methods will provide identification information about cell-surface proteins and will help with the creation of three-dimensional structural maps of monoclonal antibodies.
Willie May, acting under secretary of commerce for standards and technology and acting NIST director, said the partnership will bring together “MedImmune's deep industry understanding and NIST's measurement expertise to expand our knowledge of biopharmaceuticals-a growing field with huge economic and health impacts.”
In addition to the aforementioned projects, NIST also plans to conduct other activities in support of the development and manufacture of biologic drugs. "One project will be to develop a mass spectral library of key cell-surface proteins," Michael E. Newman, senior communications officer of NIST told BioPharm International. "Another project will be to develop new DNA-typing techniques to better identify cells lines used in the production of protein therapeutics, which will help in meeting regulatory requirements and help understand the 'genetic drift' of certain cell lines. Finally, the third project will be to develop a fluorescence-based method to predict the stability of freeze-dried protein therapeutics."