Abstract: The present invention relates to method of using spectroscopy for real time measuring of concentration of desired product and using measured data for monitoring and control of chromatography. It develops a method and system for measuring real-time concentration of clarified harvest and that of flow through of loading step of the chromatography and using measured data for determining breakthrough in real-time. The two modes of operation are used viz. first mode (Part A) uses a single near infrared spectroscopy (NIR) flow cell prior to the continuous chromatography column to ensure optimal loading in each cycle based on dynamic binding capacity studies carried out previously with the desired Protein A resin and second mode (Part B) uses two near infrared spectroscopy (NIR) flow cells, one before and one after the column, to detect the breakthrough curve (from 1% breakthrough onwards).

Abstract: The present disclosure relates to a formulation including: a) a dendron of Formula I; b) at least one bio-therapeutic; c) at least one buffer; and d) at least one salt, wherein the bio-therapeutic to dendron molar ratio is in the range of 1:0.5-1:3. The dendron stabilizes the bio-therapeutic in the formulation at a temperature of up to 55° C.

Abstract: Process control of continuous production of biomolecules is a major challenge due to complex nature of processes and time scales of operations involved. Availability of key process variables in real-time is one of main requirements. This disclosure relates to a processor implemented method of controlling a continuous bioprocessing plant which includes at least one of: receiving, an input data associated with one or more equipments; generating, by a recipe builder, a sequence of unit operations to determine at least one job order based on the at least input data; obtaining, a control decision associated with a control parameter based on the at least one job order; communicating, via the middleware, the control decision associated with the control parameter to the PLC; and executing, by a control system of the PLC, the control decision on a unit equipment to control: (i) a continuous bioprocessing train, and (ii) an individual unit operation.

Abstract: The present invention relates to method of using spectroscopy for real time measuring of concentration of desired product and using measured data for monitoring and control of chromatography. It develops a method and system for measuring real-time concentration of clarified harvest and that of flow through of loading step of the chromatography and using measured data for determining breakthrough in real-time. The two modes of operation are used viz. first mode (Part A) uses a single near infrared spectroscopy (NIR) flow cell prior to the continuous chromatography column to ensure optimal loading in each cycle based on dynamic binding capacity studies carried out previously with the desired Protein A resin and second mode (Part B) uses two near infrared spectroscopy (NIR) flow cells, one before and one after the column, to detect the breakthrough curve (from 1% breakthrough onwards).

Abstract: The present disclosure relates to a formulation including: a) a dendron of Formula I; b) at least one bio-therapeutic; c) at least one buffer; and d) at least one salt, wherein the bio-therapeutic to dendron molar ratio is in the range of 1:0.5-1:3. The dendron stabilizes the bio-therapeutic in the formulation at a temperature of up to 55° C.

Abstract: The present invention relates to methods for purification of recombinant human granulocyte colony stimulating factor (rHu GCSF). The present invention particularly relates to methods for purification of rHu GCSF involving techniques such as aqueous two phase extraction and multimodal chromatographic purification to obtain highly purified rHu GCSF. The present invention also provides a pharmaceutical composition comprising the rHu GCSF, purified using the methods described herein.

Abstract: The present invention relates to methods for purification of recombinant human granulocyte colony stimulating factor (rHu GCSF). The present invention particularly relates to methods for purification of rHu GCSF involving techniques such as aqueous two phase extraction and multimodal chromatographic purification to obtain highly purified rHu GCSF. The present invention also provides a pharmaceutical composition comprising the rHu GCSF, purified using the methods described herein.