Abstract: A Raman spectroscopy integrated perfusion cell culture system for monitoring and auto-controlling perfusion cell culture, comprising: a bioreactor, comprising: (1) an interior chamber for receiving a cell culture, (2) a port for feeding nutrient materials from a feed reservoir into the interior chamber, (3) a port for auto-bleeding from the interior chamber, and (4) a port for continuously harvesting materials from the interior chamber with the help of a cell retention system; a Raman analyzer, comprising (i) one or more Raman probes which are immersed into the bioreactor and is configured to collect Raman spectrum in the bioreactor, and (ii) a host computer which is configured to receive the Raman spectrum collected and transferred by the Raman probe and turn it into values; and a controller in communication with the Raman analyzer, the feed reservoir and an auto-bleeding device, the controller being configured to receive the values from the Raman analyzer and compare them with preset parameters, based on re

Abstract: Provided are a genetically modified cell line producing a recombinant glycoprotein having a mannose-terminated N-glycan and a method for producing the recombinant glycoprotein or a method for generating the cell, clone or cell line. The cell line comprises an insertion of less than 600 bp in the coding region of a chromosomal sequence encoding MGAT1.

Abstract: An apparatus and a method for continuously harvesting a biological substance produced by a cultured cell. An apparatus and a method for continuously harvesting a biological substance produced by a cultured cell using 2 sets of filters having different pore sizes.

Abstract: Provided are a method and a system for culturing cells and harvesting biologics. More particularly process for cell culture by intensified perfusion with continuous harvest and without cell bleeding is provided.

Abstract: A Raman spectroscopy integrated perfusion cell culture system for monitoring and auto-controlling perfusion cell culture, comprising: a bioreactor, comprising: (1) an interior chamber for receiving a cell culture, (2) a port for feeding nutrient materials from a feed reservoir into the interior chamber, (3) a port for auto-bleeding from the interior chamber, and (4) a port for continuously harvesting materials from the interior chamber with the help of a cell retention system; a Raman analyzer, comprising (i) one or more Raman probes which are immersed into the bioreactor and is configured to collect Raman spectrum in the bioreactor, and (ii) a host computer which is configured to receive the Raman spectrum collected and transferred by the Raman probe and turn it into values; and a controller in communication with the Raman analyzer, the feed reservoir and an auto-bleeding device, the controller being configured to receive the values from the Raman analyzer and compare them with preset parameters, based on re

Abstract: The disclosure generally relates to the fields of immunology, cell biology, molecular biology and medicine. More particularly, it concerns polypeptide complex for conjugation and use thereof. A polypeptide complex comprising, from N-terminus to C-terminus, a Fab domain operably linked to a hinge region is provided, wherein the Fab domain and the hinge region are derived from different IgG isotypes, or part thereof. The polypeptide complex further comprises a Fc polypeptide which is operably linked to the hinge region. The present disclosure provides an antibody drug conjugate comprising a polypeptide complex of the present disclosure.

Abstract: Provided is a polynucleotide the polynucleotide can be used as a WXRE transcriptional regulatory element used to increase the protein expression level of a protein expression system. A protein expression vector or a protein expression systems comprising the above-mentioned WXRE transcriptional regulatory element as well as the use thereof are also provided. The use of the WXRE transcriptional regulatory element can increase the expression level of a heterologous protein greatly with its biological activity unchanged.

Abstract: Provided is a polynucleotide, the polynucleotide can be used as a WXRE transcriptional regulatory element used to increase the protein expression level of a protein expression system. A protein expression vector or a protein expression system comprising the above-mentioned WXRE transcriptional regulatory element as well as the use thereof are also provided. The use of the WXRE transcriptional regulatory element can increase the expression level of a heterologous protein greatly with its biological activity unchanged.

Abstract: Protein A chromatography is generally less effective in removing antibody aggregates under typical conditions. Provided is a combination and a method that can significantly improve Protein A's aggregate removal capability. The combination comprises polyethylene glycol (PEG) and a salt (chaotropic or kosmotropic) as wash and elution buffer additives. The synergistic effect of salt and PEG results in almost complete separation of monomer from aggregates. For the case used for demonstration, in comparison with the control run the optimized procedure reduces aggregates in elution pool from 20% to 3-4%. This new method, by facilitating aggregate removal at the capture step, improves the overall robustness of downstream process.

Abstract: Provided is a polynucleotide, the polynucleotide can be used as a WXRE transcriptional regulatory element used to increase the protein expression level of a protein expression system. A protein expression vector or a protein expression system comprising the above-mentioned WXRE transcriptional regulatory element as well as the use thereof are also provided. The use of the WXRE transcriptional regulatory element can increase the expression level of a heterologous protein greatly with its biological activity unchanged.

Abstract: Provided herein are seed train processes and methods of producing a recombinant protein that include the use of these seed train processes.

Abstract: Provided herein are methods of perfusion culturing an adherent mammalian cell using a shake flask and a plurality of microcarriers, and various methods that utilize these culturing methods.

Abstract: Provided herein are methods of perfusion culturing an adherent mammalian cell using a shake flask and a plurality of microcarriers, and various methods that utilize these culturing methods.

Abstract: Provided herein are seed train processes and methods of producing a recombinant protein that include the use of these seed train processes.

Abstract: Provided herein are methods of perfusion culturing an adherent mammalian cell using a shake flask and a plurality of microcarriers, and various methods that utilize these culturing methods.

Abstract: Provided herein are methods of perfusion culturing an adherent mammalian cell using a shake flask and a plurality of microcarriers, and various methods that utilize these culturing methods.

Abstract: Provided herein are methods of culturing a mammalian cell and various methods that utilize these culturing methods.

Abstract: Provided herein are seed train processes and methods of producing a recombinant protein that include the use of these seed train processes.

Abstract: The present invention is directed to stable protein derivatives, e.g., antibodies, antibody fragments or peptides, with at least one free thiol group coupled to N-acetyl-L-cysteine, N-ethyl-maleimide, or cysteine and the methods of making such derivatives. In addition, stable liquid pharmaceutical formulations comprising such proteins or their derivatives and stable lyophilized pharmaceutical formulations comprising such proteins are provided. The present invention is also directed to a method of making a stable Fab? fragment of an antibody and a method of controlling vascularization in injured or cancerous tissue comprising applying to the injured tissue one or more doses of the pharmaceutical formulations.

Abstract: A process for large scale virus production is disclosed, especially large scale adenovirus production. The methods described are preferably adapted to suspension culture of mammalian host cells in a large scale bioreactor where gas sparging becomes essential to provide adequate aeration through the duration of the culture. This methodology includes an elevated concentration of a compound which protects host cells from the shearing effects of gas sparging and agitation as well as utilizing virus seed stocks which have been generated free of cell lysis reagents. The invention also relates to methods of producing these virus seed stocks, which are scaleable and the resultant unclarified virus seed stocks which are concentrated to reduce storage volume for infection of large scale culture and which are free of cell lysis components, such as the detergent Triton X-100 or Polysorbate 80.