6-Chloro-6-deoxy-D-hexitols, their esters, their preparation, fertility control compositions containing them and their use in a contraceptive method
申请人:TATE & LYLE PUBLIC LIMITED COMPANY
公开号:EP0015652A1
公开(公告)日:1980-09-17
6-Chloro-6-deoxy-D-hexitols, a novel class of compounds, and their esters, possess male antifertility activity and are thus useful in antifertility compositions. They are prepared by reduction of 6-chloro-6-deoxy-D-hexoses.
METHOD FOR OPTIMIZING POST-TRANSLATIONAL MODIFICATIONS ON RECOMBINANT PROTEINS
申请人:Leszcyniecka, Magdalena
公开号:EP3094639A1
公开(公告)日:2016-11-23
Method for Optimizing Post-Translational Modifications on Recombinant Proteins
申请人:LESZCYNIECKA Magdalena
公开号:US20160340706A1
公开(公告)日:2016-11-24
A method for optimizing post-translational modifications of recombinant proteins expressed in living cells is described. More particularly, a method for modulation of host proteins in living cells that control PTMs on recombinant proteins is described that has particularly useful applications in developing manufacturing process changes or in biosimilar development. The goal of this modulation is to produce a recipe for production of a recombinant protein in the new process or in the biosimilar that will produce a targeted PTM profile in the resulting protein product. In the method one or more modulators are selected, as from a modulator library, which affect the activity of host proteins. These modulators are added to media during production such that the resulting product matches the PTMs of the reference product. The ideal set of modulators and their concentrations are identified through a unique iterative process and the combined modulators and their concentrations constitute a recipe for growth media for the production of said recombinant protein. The methodology to obtain such a recipe described herein may then be used in many applications, such as optimizing new batches of recombinant protein drugs, developing biosimilar or bio-better drugs.
A METHOD FOR DEVELOPMENT OF RECOMBINANT PROTEINS WITH FINGERPRINT LIKE SIMILARITY TO THE REFERENCE PRODUCT
申请人:STC Biologics, Inc.
公开号:US20180180626A1
公开(公告)日:2018-06-28
The present invention relates to the methods of developing recombinant proteins with a fingerprint like similarity to the reference product or the originator. The method is particularly useful in the development of biosimilar products. This method can also be used to establish comparability during the manufacturing process change for the originator products. Hie methods described herein are used to obtain a recipe for the production of a biosimilar product or a recombinant protein using a process that may be different from the original but that yields a recombinant protein that has fingerprint level of similarity to the reference product. The methods described herein can also used to obtain a fingerprinting analysis package for a biosimilar that can be submitted to regulatory agency for abbreviated biosimilar approval. While currently available analytical methods can identify and quantitate specific modifications on a recombinant, protein, no methods currently exist to measure and determine the concentration of product variants in a complex: mixture. The analytical methods described herein provide for identification and quantitation of the modifications of the recombinant proteins and of product variants in a complex mixture by utilizing various in silico computational approaches to transform analytical data and derive product variant distribution.