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The company’s method reduces the time required to crystallize antibodies from weeks to one day.
Contract development and manufacturing organization (CDMO) Ajinomoto Althea announced on May 17, 2016 that the United States Patent and Trademark Office (USPTO) has issued the company a patent covering methods to crystallize monoclonal antibodies (mAbs) for the purposes of stabilization, storage, and safe delivery of active antibody crystals.
The patent language describes the Crystalomics Formulation technology as crystals (whole antibody crystals, antibody fragment crystals, or formulations comprising these components) that “are used as a carrier-free delivery system.” The delivery system has the capability to “slowly release active whole antibodies or fragments thereof, to a subject, where and when they are needed.” The patent also describes methods to encapsulate crystals or crystal formulations in a polymeric carrier.
The technology works for mAbs, recombinant proteins, peptides, vaccines, DNA, and antibiotics, although the patent only specifically covers whole antibody crystals. It was developed to resolve issues related to viscosity, aggregation, and stability of complex biologic therapeutics. The technology will help prevent the chemical and physical denaturation that can occur during product manufacture and storage, and according to a company press release, “may enable alternative routes of delivery that are more patient friendly.” Specifically, the patent describes this route as an implantable device containing crystallized antibodies that could be “used as a basis for slow release in vivo.” Use of this type of device could increase the biological half-life of the therapeutic product.
In summary, the patent states, “The process of crystallization of whole antibodies serves not only as a powerful protein purification or stabilization tool but also affords the most concentrated protein form possible.”
Source: Ajinomoto Althea, USPTO